advanced medical technologies http://blog.mediligence.com insights, perspectives and inside data from medtech market analysis at MedMarket Diligence, LLC Mon, 30 May 2016 20:49:11 +0000 en-US hourly 1 Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022 http://blog.mediligence.com/2016/05/30/global-dynamics-of-surgical-and-interventional-cardiovascular-procedures-2015-2022/ Mon, 30 May 2016 20:49:11 +0000 http://blog.mediligence.com/?p=9321 Continue reading Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022]]> Publishing June 2016:
Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022

This is a global report from MedMarket Diligence detailing from 2015 to 2022 the volume of interventional and surgical cardiovascular procedures, including open heart, peripheral vascular, cerebrovascular and all associated endovascular interventions.

Table of Contents

Executive Summary

Section 1: Common Acute and Chronic Cardiovascular Conditions Targeted by Surgical and Transcatheter Interventions

1.1     Ischemic Heart Disease

1.1.1     Angina Pectoris
1.1.2     Acute Myocardial Infarction
1.1.3     Incidence, Prevalence, Established Treatment Modalities

1.2     Heart Failure

1.2.1     Incidence, Prevalence, Established Treatment Modalities

1.3     Peripheral Artery Disease

1.3.1     Critical Limb Ischemia
1.3.2     Incidence, Prevalence, Established Treatment Modalities
1.3.3     Aortic Aneurysm
1.3.4     Incidence, Prevalence, Established Treatment Modalities

1.4     Peripheral Venous Disorders

1.4.1     Deep Venous Thrombosis and Pulmonary Embolism
1.4.2     Chronic Venous Insufficiency and Varicose Veins
1.4.3     Incidence, Prevalence, Established Treatment Modalities

1.5     Cerebrovascular Disorders

1.5.1     Cerebrovascular Occlusions and Acute Ischemic Stroke
1.5.2     Cerebral Aneurysm & AVM and Hemorrhagic Stroke
1.5.3     Incidence, Prevalence, Established Treatment Modalities

1.6     Structural Heart Disorders

1.6.1     Congenital Heart Defects

1.6.1.1     Incidence, Prevalence, Established Treatment Modalities

1.6.2     Valvular Disorders

1.6.2.1     Incidence, Prevalence, Established Treatment Modalities

1.7     Cardiac Rhythm Disorders

1.7.1     Bradycardia
1.7.2     Tachycardia

1.7.2.1     Atrial Fibrillation

1.7.3     Incidence, Prevalence, Established Treatment Modalities

Section 2: Current and Projected Volumes of Therapeutic Interventional and Surgical Cardiovascular Procedures

2.1    Coronary Artery Revascularization

2.1.1    Coronary Artery Bypass Graft Surgery

2.1.1.1    Utilization Trends and Procedure Volumes

2.1.2    Percutaneous Coronary Interventions

2.1.2.1    Coronary Angioplasty and Stenting

2.1.2.1.1 Utilization Trends and Procedure Volumes

2.1.2.2    CoronaryMechanical and Laser Atherectomy

2.1.2.2.1 Utilization Trends and Procedure Volumes

2.1.2.3    Mechanical Thrombectomy

2.1.2.3.1 Utilization Trends and Procedure Volumes

2.2    Acute and Chronic Heart Failure Management

2.2.1    Ventricular Assist Device Placement

2.2.1.1    Utilization Trends and Procedure Volumes

2.2.2    Total Artificial Heart Implantation

2.2.2.1    Utilization Trends and Procedure Volumes

2.2.3    Donor Heart Transplantation

2.2.3.1    Utilization Trends and Procedure Volumes

2.3    Peripheral Artery Revascularization

2.3.1    Lower Extremity Arterial Bypass Surgery

2.3.1.1    Utilization Trends and Procedure Volumes

2.3.2     Percutaneous Transcatheter Interventions

2.3.2.1    Angioplasty and Stenting

2.3.2.1.1 PTA and Bare Metal Stenting
2.3.2.1.2 PTA and Drug-Eluting Stenting
2.3.2.1.3 PTA with Drug-Coated Balloons
2.3.2.1.4 Utilization Trends and Procedure Volumes

2.3.2.2    Mechanical and Laser Atherectomy

2.3.2.2.1 Utilization Trends and Procedure Volumes

2.3.2.3    Catheter-Directed Thrombolysis and Thrombectomy

2.3.2.3.1 Utilization Trends and Procedure Volumes

2.4    Aortic Aneurysm Repair

2.4.1    Surgical AAA and TAA Repair
2.4.2    Endovascular AAA and TAA Repaire
2.4.3    Utilization Trends and Procedure Volumes

2.5    DVT and CVI Management

2.5.1    Vena Cava Filter Placement

2.5.1.1    Utilization Trends and Procedure Volumes

2.5.2    Endovenous Ablation

2.5.2.1    Utilization Trends and Procedure Volumes

2.5.3    Venous Revascularization

2.5.3.1    Mechanical Thrombectomy
2.5.3.2    Venous Angioplasty and Stenting
2.5.3.2     Utilization Trends and Procedure Volumes

2.6    Acute Stroke Prophylaxis and Treatment

2.6.1    Carotid Artery Stenosis Management

2.6.1.1    Carotid Endarterectomy
2.6.1.2    Carotid Artery Stenting
2.6.1.3    Utilization Trends and Procedure Volumes

2.6.2    Cerebral Thrombectomy

2.6.2.1    Utilization Trends and Procedure Volumes

2.6.3    Cerebral Aneurysm and AVM Repair

2.6.3.1    Cerebral Aneurysm and AVM Surgical Clipping
2.6.3.2    Cerebral Aneurysm and AVM Coiling & Flow Diversion
2.6.3.3    Utilization Trends and Procedure Volumes

2.7    Treatment of Structural Heart Disorders

2.7.1     Congenital Heart Defect Repair

2.7.1.1    Utilization Trends and Procedure Volumes

2.7.2    Heart Valve Repair and Replacement

2.7.2.1    Heart Valve Repair and Replacement Surgery
2.7.2.2    Utilization Trends and Procedure Volumes
2.7.2.3    Transcatheter Valve Repair and Replacement
2.7.2.4    Utilization Trends and Procedure Volumes

2.8    Cardiac Rhythm Management

2.8.1    Implantable Pulse Generator-Based Therapy

2.8.1.1    Pacemaker Implantation
2.8.1.2    Implantable Cardioverter Defibrillator Placement
2.8.1.3    Cardiac Resynchronization Therapy Device Placement
2.8.1.4    Utilization Trends and Procedure Volumes

2.8.2    Arrhythmia Ablation Therapy

2.8.2.1    Standard SVT Ablation
2.8.2.2    Utilization Trends and Procedure Volumes
2.8.2.3    AFib Ablation

2.8.2.3.1 Surgical AFib Ablation
2.8.2.3.2 Transcatheter AFib Ablation
2.8.2.3.3 Utilization Trends and Procedure Volumes

Section 3: Country Healthcare Profiles

3.1    United States and Other Americas

3.1.1    United States
3.1.2    Brazil
3.1.3    Canada
3.1.4    Mexico

3.2    Largest West European States

3.2.1    France
3.2.2    Germany
3.2.3    Italy
3.2.4    Spain
3.2.5    United Kingdom

3.3    Major Asian States

3.3.1    China
3.3.2    India
3.3.3    Japan


Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022
June 2016
Price:  $3,950 (print or PDF; add $200 for both).  Site/Global License also available.
For immediate download, order online or fax your order form.  Site/Global License also available.

 

 

 

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Sealants, hemostats, glues — future markets foreseen http://blog.mediligence.com/2016/05/26/sealants-hemostats-glues-future-markets-foreseen/ Thu, 26 May 2016 23:43:12 +0000 http://blog.mediligence.com/?p=9316 Continue reading Sealants, hemostats, glues — future markets foreseen]]> From our past coverage of surgical sealants, glues, hemostats in our 2014 Report #S192.  (See the forthcoming June 2016 report, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022”, Report #S290.)

Fibrin and synthetic sealants offer a significant advantage over pure hemostats because they do not rely on the full complement of blood factors to produce hemostasis. Sealants provide all the components necessary to prevent bleeding and will often prevent bleeding from tissues where blood flow is under pressure and the damage is extensive.

CryoLife
Source: CryoLife

These products have the potential to replace sutures in some cases where speed and strength of securement are priorities for the surgical procedure.

Biologically active sealants typically contain various formulations of fibrin and/or thrombin, either of human or animal origin, which mimic or facilitate the final stages of the coagulation cascade. The most common consist of a liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder. Before use, both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components just prior to delivery to the wound. Because of the laborious preparation process, these products are not easy to use. However, manufacturers have been developing some new formulations designed to make the process more user friendly. Leaders in biologic surgical sealant space include Baxter International and Johnson & Johnson’s Ethicon Biosurgery division, but there are a number of smaller suppliers as well, in what has become an increasingly crowded field.

Compared to biologically active sealants containing fibrin and other human- or animal-derived products, synthetic sealants represent a much larger segment of the sealant market in terms of the number of competitors, variety of products, and next-generation products in development. Non-active synthetic sealants do not contain ingredients such as fibrin that actively mediate the blood clotting cascade, rather they act as mechanical hemostats, binding with or adhering to the tissues to help stop or prevent active bleeding during surgery.

Synthetic sealants represent an active category for R&D investment in large part because they offer several advantages over fibrin-based and other biologically active sealants. First and foremost, they are not derived from animal or human donor sources and thus eliminate the risks of disease transmission. Moreover, they are typically easier to use than biological products, often requiring no mixing or special storage, and many of these products have demonstrated improved sealing strength versus their biological counterparts. Synthetic products also have the potential to be more cost-effective than their biologically active counterparts. Leaders in the synthetic surgical sealants space include Baxter International Inc., CryoLife, CR Bard, and Ethicon/J&J; however, there are many up-and-coming competitors operating in this segment of the market with some interesting next-generation technologies that could gain significant traction in the years ahead. Moreover, unlike the fibrin sealants segment, where most products have more general indications for surgical hemostasis, a good number of competitors in the synthetic sealant field are focused on specific clinical applications for their products, such as cardiovascular surgery, plastic surgery, or ophthalmic surgery.

Sealants-Hemostats-Glues-companies-by-type
Source: Report #S192 (pub. 2014)

The non-active hemostats segment of the market includes a variety of scaffolds, patches, sponges, putties, powders, and matrices made of various nonactive materials that act mechanically to stop/absorb active bleeding, often in conjunction with manual compression, during surgical procedures as well as emergency use. Many of the companies active in the first two market segments discussed above also participate in this sector, including Ethicon/J&J, CR Bard, Baxter, and CryoLife, but there are also many other companies that compete in the hemostats market worldwide.


MedMarket Diligence is completing a global analysis of medical and surgical sealants, glues, and hemostats to reveal the patterns of sales, product adoption rates, and the realized/unrealized opportunities for extant stakeholders inclusive of manufacturers, buyers, and the investment arena. Publishing in June 2016, Report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022”.

 

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Growth Factors in Wound Management http://blog.mediligence.com/2016/05/24/growth-factors-in-wound-management-3/ Tue, 24 May 2016 22:38:08 +0000 http://blog.mediligence.com/?p=9312 Growth Factors, Production and Known Effects in Wound Healing
Growth FactorProduced byCurrently Known Effects
Epidermal Growth Factor (EGF)Platelets, macrophagesStimulates fibroblasts to secrete collagenase to degrade the matrix during the remodeling phase. Stimulates keratinocyte and fibroblast proliferation. May reduce healing time when applied topically.
Transforming Growth Factor (TGF)Platelets, macrophages, lymphocytes, hepatocytesTGF-a: Mitogenic and chemotactic for keratinocytes and fibroblasts
TGFPlatelets, macrophages, lymphocytes, hepatocytesTGF-b1 and TGF-b2: Promotes angiogenesis, up-regulates collagen production and inhibits degradation, promotes chemo attraction of inflammatory cells.
TGFPlatelets, macrophages, lymphocytes, hepatocytesTGF-b3 (antagonist to TGF-b1 and b2): Has been found in high levels in fetal scarless wound healing and has promoted scarless healing in adults experimentally when TGF-b1 and TGF-b2 are suppressed.
Vascular Endothelial Growth Factor (VEGF)Endothelial cellsPromotes angiogenesis in hypoxic tissues.
Fibroblast Growth Factor (FGF)Macrophages, mast cells, T-lymphocytesPromotes angiogenesis, granulation, and epithelialization via endothelial cell, fibroblast, and keratinocyte migration, respectively.
Platelet-Derived Growth Factor (PDGF)Platelets, macrophages, and endothelial cellsAttracts macrophages and fibroblasts to zone of injury. Promotes collagen and proteoglycan synthesis.
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-1: Proinflammatory, chemotactic for neutrophils, fibroblasts, and keratinocytes. Activates neutrophils
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-4: Activates fibroblast differentiation. Induces collagen and proteoglycan synthesis.
InterleukinsMacrophages, keratinocytes, endothelial cells, lymphocytes, fibroblasts, osteoblasts, basophils, mast cellsIL-8: Chemotactic for neutrophils and fibroblasts.
Colony Stimulating Factors (CSF)Stromal cells, fibroblasts, endothelial cells, lymphocytesGranulocyte colony stimulating factor (G-CSF): Stimulates granulocyte proliferation.
CSFStromal cells, fibroblasts, endothelial cells, lymphocytesGranulocyte Macrophage Colony Stimulating Factor (GM-CSF): Stimulates granulocyte and macrophage proliferation.
Keratinocyte growth factorFibroblastsStimulates keratinocyte migration, differentiation, and proliferation.

Source: “Wound Management to 2024”, Report #S251

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Wound healing factors; Growth in peripheral stenting; Nanomed applications http://blog.mediligence.com/2016/05/23/wound-healing-factors-growth-in-peripheral-stenting-nanomed-applications/ Mon, 23 May 2016 20:40:33 +0000 http://blog.mediligence.com/?p=9306 Continue reading Wound healing factors; Growth in peripheral stenting; Nanomed applications]]> From our weekly email to blog subscribers…

Extrinsic Factors Affecting Wound Healing

From Report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World.”

Extrinsic factors affecting wound healing include:

Mechanical stress
Debris
Temperature
Desiccation and maceration
Infection
Chemical stress
Medications
Other factors

Mechanical stress factors include pressure, shear, and friction. Pressure can result from immobility, such as experienced by a bed- or chair-bound patient, or local pressures generated by a cast or poorly fitting shoe on a diabetic foot. When pressure is applied to an area for sufficient time and duration, blood flow to the area is compromised and healing cannot take place. Shear forces may occlude blood vessels, and disrupt or damage granulation tissue. Friction wears away newly formed epithelium or granulation tissue and may return the wound to the inflammatory phase.

Debris, such as necrotic tissue or foreign material, must be removed from the wound site in order to allow the wound to progress from the inflammatory stage to the proliferative stage of healing. Necrotic debris includes eschar and slough. The removal of necrotic tissue is called debridement and may be accomplished by mechanical, chemical, autolytic, or surgical means. Foreign material may include sutures, dressing residues, fibers shed by dressings, and foreign material which were introduced during the wounding process, such as dirt or glass.

Temperature controls the rate of chemical and enzymatic processes occurring within the wound and the metabolism of cells and tissue engaged in the repair process. Frequent dressing changes or wound cleansing with room temperature solutions may reduce wound temperature, often requiring several hours for recovery to physiological levels. Thus, wound dressings that promote a “cooling” effect, while they may help to decrease pain, may not support wound repair.

Desiccation of the wound surface removes the physiological fluids that support wound healing activity. Dry wounds are more painful, itchy, and produce scab material in an attempt to reduce fluid loss. Cell proliferation, leukocyte activity, wound contraction, and revascularization are all reduced in a dry environment. Epithelialization is drastically slowed in the presence of scab tissue that forces epithelial cells to burrow rather than freely migrate over granulation tissue. Advanced wound dressings provide protection against desiccation.

Maceration resulting from prolonged exposure to moisture may occur from incontinence, sweat accumulation, or excess exudates. Maceration can lead to enlargement of the wound, increased susceptibility to mechanical forces, and infection. Advanced wound products are designed to remove sources of moisture, manage wound exudates, and protect skin at the edges of the wound from exposure to exudates, incontinence, or perspiration.

Infection at the wound site will ensure that the healing process remains in the inflammatory phase. Pathogenic microbes in the wound compete with macrophages and fibroblasts for limited resources and may cause further necrosis in the wound bed. Serious wound infection can lead to sepsis and death. While all ulcers are considered contaminated, the diagnosis of infection is made when the wound culture demonstrates bacterial counts in excess of 105 microorganisms per gram of tissue. The clinical signs of wound infection are erythema, heat, local swelling, and pain.

Chemical stress is often applied to the wound through the use of antiseptics and cleansing agents. Routine, prolonged use of iodine, peroxide, chlorhexidine, alcohol, and acetic acid has been shown to damage cells and tissue involved in wound repair. Their use is now primarily limited to those wounds and circumstances when infection risk is high. The use of such products is rapidly discontinued in favor of using less cytotoxic agents, such as saline and nonionic surfactants.

Medication may have significant effects on the phases of wound healing. Anti-inflammatory drugs such as steroids and non-steroidal anti-inflammatory drugs may reduce the inflammatory response necessary to prepare the wound bed for granulation. Chemotherapeutic agents affect the function of normal cells as well as their target tumor tissue; their effects include reduction in the inflammatory response, suppression of protein synthesis, and inhibition of cell reproduction. Immunosuppressive drugs reduce WBC counts, reducing inflammatory activities and increasing the risk of wound infection.

Other extrinsic factors that may affect wound healing include alcohol abuse, smoking, and radiation therapy. Alcohol abuse and smoking interfere with body’s defense system, and side effects from radiation treatments include specific disruptions to the immune system, including suppression of leukocyte production that increases the risk of infection in ulcers. Radiation for treatment of cancer causes secondary complications to the skin and underlying tissue. Early signs of radiation side effects include acute inflammation, exudation, and scabbing. Later signs, which may appear four to six months after radiation, include woody, fibrous, and edematous skin. Advanced radiated skin appearances can include avascular tissue and ulcerations in the circumscribed area of the original radiation. The radiated wound may not become evident until as long as 10-20 years after the end of therapy.

Source: “Wound Management to 2024”, Report #S251.


Screen Shot 2016-05-22 at 8.35.06 PM

Source: “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.


Selected Therapeutic and Diagnostic Applications of Nanotechnology in Medicine

Below are selected applications for neuromedical technologies in development or on the market currently.

Drug Delivery
Chemotherapy drug delivery
Magnetic nanoparticles attached to cancer cells
Nanoparticles carrying drugs to arterial wall plaques
Therapeutic magnetic carriers (TMMC) [guided using magnetic resonance navigation, or MRN]

Drugs and Therapies
Diabetes
Combatting antimicrobial resistance
Alzheimer’s Disease
Infectious Disease
Arthritis

Tissue, cell and genetic engineering involving nanomedical tools
Nanomedical tools in gene therapy for inherited diseases
Artificial kidney
ACL replacements
Ophthalmology
Implanted nanodevices for alleviation of pain

Biomaterials 

Nanomedicine and Personalized Treatments

Source: Report #T650, “Global Nanomedical Technologies, Markets and Opportunities, 2016-2021”. Report #T650.

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Medtech is Dead. Long Live Medtech. http://blog.mediligence.com/2016/05/11/medtech-is-dead-long-live-medtech/ Wed, 11 May 2016 15:15:40 +0000 http://blog.mediligence.com/?p=9296 Continue reading Medtech is Dead. Long Live Medtech.]]> The old Chinese saying, “May you live in interesting times”, is often used as a curse (and likely originated as such), since interesting is oft synonymous with challenging, uncertain, stressful or otherwise difficult. Insult or blessing, we are entering interesting times.

The coming era of development in medical technology may be the most interesting in history. Let’s get to it.

Consider the near term:

Cost pressures, demands for improved outcomes, and need for better access to healthcare have been rising to the fore as forces overhauling markets for medical technologies.

Chronic disease has always represented a major cost challenge, given the expense of ongoing care, but as cost and quality become more demanding, while prevalence of type 2 diabetes, obesity, and associated co-morbidities increase (and compounded by higher prevalence of type 2 in an increasingly older population), driven by persistent sedentary lifestyles, diet, and other health choices, it becomes clear that chronic disease will command much attention, representing real opportunities in medtech.

Never before have so many technologies, alone or in combination, been poised to change the nature of intervention:

  • bioabsorbable, bioactive, & biocompatible devices
  • drug-device hybrids
  • surgical innovations: sutureless surgery, natural orfice surgery, intraoperative imaging and intraoperative pathology assessment, energy-based technologies;
  • information-intensive device, drug, and biotech product development
  • information-intensive medical devices
  • genetically-influenced drug development

In the medium term (next 5-10 years):

  • Type 1 diabetes gradually becomes less burdensome, with fewer complications, and improved quality of life for patients.
  • Type 2 diabetes continues to plague Western markets in particular, despite advances in diagnosis, treatment, and monitoring due to challenges in patient compliance.
  • Cancer five year survival rates will dramatically increase for many cancers. The number of hits on Google searches for “cure AND cancer” will reflect this.
  • Multifaceted approaches available for treatment of traumatic brain injury and spinal cord injury – encompassing exoskeletons to help retrain/rehabilitate and increase functional mobility, nerve grafting, cell/tissue therapy, and others.
  • Organ/device hybrids will proliferate and become viable alternatives to transplant, or bridge-to-transplant, for pulmonary assist, kidney, liver, heart, pancreas and other organ.
  • The use of stem cells for therapeutics is a radically different type of medicine, and while stem cells can be powerfully therapeutic, their use has also shown the potential to cause new cancer, graft-versus-host disease, organ damage, infection, and other direct and indirect complications. Nonetheless, the excitement around stem and other pluripotent cells creates a climate not far removed from the wild west – the potential of such open territory being up for grabs has drawn hordes of activity, not all in the best interests of patients or shareholders. The stem cell industry and others will continue to press the FDA to approve more therapies, with the pressure easing up only after a scarcity of patient deaths, complications, or just lackluster results.

Beyond 10 years, many things might happen, but which one actually happens (or the degree of its success) will be dictated by timing.

Will the big success in diabetes as we approach 2030 be cell-based — as in autogeneic pancreatic cells induced from stem cells — or will the state of the art at that time still be the “pump/meter closed loop artificial pancreas” (expected to be the case well before 2030?

Will tissue engineering allow us to preempt death?

The potential for us to preempt an enormous amount of disease is already before us, yet we studiously avoid it. At what point do we take advantage of this?

Consider what will be the case beyond 2026.

Research gaps will have narrowed drastically. The gap between basic science and clinical application will be very small. Our medical diagnostics will be extremely richly detailed, near-instantaneous, and widely accessible (e.g., there will be variants or embodiments of IBM Watson and similar intelligent diagnostic systems), which will of course optimize the potential for therapeutics. But the impact on research will be dramatic, because we will be able to much more rapidly and efficiently learn from an obvious integration of routine clinical data and research data via meta-analysis-esque (for lack of a less clumsy term) capacity to derive data from disparate local and remote systems.

Our nearly complete knowledge of the full spectrum of pathogenic factors (from environmental to genetic) and their correlation with specific patient populations will have pierced the veil that has concealed the etiologies of a large number of diseases, opening the door wide to the development of therapies.

We will understand, predict, and manage the development of genetic disease.

All political denial to the side, some of the most significant threats to our health in the future will ensue from our relentless campaign to ravage the planet’s resources – air, water, food – driven by overpopulation and happily capitalized upon by what we are seeing is a growing horde of lethal, many well evolved but otherwise persistent pathogens (from tuberculosis, MRSA, Ebola, Marburg, and many others as yet unidentified), already made more threatening due to antibiotic resistance we have knowingly facilitated.

However, fear not, my 2.3% excise tax refugees. The future is bright for you, if you care to recognize your place in it.

But first, here’s a blunt reality: Medical devices, at least as we know them, will simply become irrelevant. Medical devices, no matter how sophisticated, are clunky mechanical tools for amelioration of symptoms for diseases about which know too little to solve with near-zero cost permanent cures (think of the vaccine, an unbelievable idea in the mind of those fearing polio) but only when drugs or other interventions are not also possible.

Let there be no doubt — medical technology will thrive. Disease is persistent. Conditions are worsening for the human population. But, more importantly, at least from the sense of an industry with a big financial stake in the situation, nature does not give up her secrets easily and there remain many obstacles to overcome (not least of which is wanton and persistent human ignorance) before we are able to utterly avoid or cheaply cure all diseases.

 

 

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Cerebral thrombectomy systems http://blog.mediligence.com/2016/05/05/cerebral-thrombectomy-systems/ Thu, 05 May 2016 16:36:25 +0000 http://blog.mediligence.com/?p=9293 Selected Cerebral Thrombectomy Systems on the U.S. and International Markets

From the 2015 report, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”.

CompanyDeviceFeaturesVessel RangeDevice Sizes (D/L)Regulatory Status
AcandisAperioSelf-expanding nitinol stent-based device with hybrid cell design and adaptable working length1.5 to 5.5 mm3.5, 4.5, 6.0 mm / 28, 30 or 40 mmCE Marked
BALTCatch+ Mini/, Catch+, Catch+ Maxi, Catch+ MegaSelf-expanding 16-wire nitinol baskets with tapering cell size design, closed distal tip and 3 distal-1 proximal radiopaque markers2.0 to 7.0 mm3.0, 4.0, 6.0, 9.0 mm / 15, 20, 30, 55 mmCE Marked
Codman /DePuyRevive SESelf-expanding nitinol basket with hybrid cell design, closed distal tip, and 3 radiopaque markers1.5 to 5.5 mm2.5, 3.0, 3.5, 4.0, 5.0, 6.0 mm / 20, 30, 40 mmCE Marked, Approved in China, South Korea, and Taiwan
CovidienSolitaire FRSelf-expanding nitinol stent-based device with Parametric design (for multiple planes of clot contact to enhance capture). Features 3 or 4 distal and 1 proximal markers2.0 to 5.5 mm4.0, 6.0 mm /26, 31, 42 mmCE Marked, FDA approved
NeuraviEmbotrapSelf-expanding nitinol stent-based device with open cell design, closed distal tip, and 3 radiopaque markers. Features dilating inner channel for rapid flow restoration and integrated distal and side branch protection2.0 to 5.5 mm3.0, 4.0, 6.0 mm / 15, 20, 30, 55 mmCE Marked
PenumbraPenumbra SystemAspiration based system comprised of vacuum pump, specialty clot capture & retrieval catheters, and Separator> 3 mm3.0, 4.0, 5.0 mm / 26 mmCE Marked, FDA approved, available in Asia, Australia, and South America
PhenoxpREsetSelf-expanding nitinol stent-based tapering device with closed ring design, and stable proximal opening2.0 to 4.0 mm4.0, 6.0 mm / 30, 45 mmCE Marked
StrykerTrevo Pro, Trevo View, Trevo XPLine of self-expanding nitinol stent-based devices (standard, all radiopaque, oversized) with spiral cell design and soft, guidewire-like closed distal tip1.5 to 4.0 mm4.0, 5.0, 6.0 mm / 20, 30, 40 mmCE Marked, FDA approved

Source: MedMarket Diligence, LLC; Report #C310.

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Surgical Procedures with Potential for Sealants, Glues, Hemostats http://blog.mediligence.com/2016/05/02/surgical-procedures-with-potential-for-sealants-glues-hemostats/ Mon, 02 May 2016 15:34:15 +0000 http://blog.mediligence.com/?p=9276 Continue reading Surgical Procedures with Potential for Sealants, Glues, Hemostats]]> Sealants, glues, and hemostats must offer benefit to be adopted in clinical practice, or surgical procedures. Benefits can fall into a number of categories. These range from preventing serious complications from surgery (blood loss), improved patient outcomes (fewer complications, reduction in repeats), reductions in procedure time or other time- or cost-saving benefits, or improved aesthetic and perceived benefits. See these detailed below.

Criteria for Adjunctive Use of Hemostats, Sealants, Glues and Adhesion Prevention Products in Surgery

Screen Shot 2016-05-02 at 8.24.47 AM

Source: MedMarket Diligence, LLC; Report#S192.

We have assessed surgical sealants, glues, and hemostats for their potential in general surgery, aesthetics, neurology, urological, gastroenterology, orthopedics, and cardiovascular medicine.

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Source: MedMarket Diligence, LLC; Report #S192, “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”.


See the forthcoming report #S290, “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World”.  (Contact us for details to acquire the 2014 report #S192 and the new report, #S290, for a combined price before S290 publishes.)

 

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It’s Personal. We fail in organ donation. Help one person. http://blog.mediligence.com/2016/04/29/its-personal-we-fail-in-organ-donation/ Fri, 29 Apr 2016 18:47:46 +0000 http://blog.mediligence.com/?p=9264 Continue reading It’s Personal. We fail in organ donation. Help one person.]]> I grew up around medicine, with a surgeon father and a pediatric uncle. I studied toward a profession in medicine as well, but I was also enormously intrigued with the science, business, and future of medicine, especially the potential emerging from biotech, with genetics and molecular biology at the top of the list. It led me to research many genetic diseases, among them cystic fibrosis (I knew someone who survived this very late, into college), and polycystic kidney disease (PKD).

Sadly, I also know someone with polycystic kidney disease, and her name is M. Christina Mayo. Tina is now in urgent need of both a kidney and liver to save her life.

I do not editorialize much here (I show restraint), but the state of organ donation in this country and worldwide is rather pathetic. We fail. And we cannot afford to fail at so simple a thing.

Last week, an old college friend of Tina’s, who also happens to be a very good friend of mine, opted to be evaluated as a “live liver” donor. (The liver is a “vital” organ, like heart and kidneys, that we can’t do without — we can donate one kidney, but techniques exist now to allow a donor to donate a lobe of the liver, rather than the whole, with the donate lobe eventually growing back.)
So, Tina’s and my friend was evaluated rigorously at UC San Francisco, where the donation would be. Unfortunately, despite so many indicators looking good, there was no match.

Tina is now making an urgent appeal (see below). And in the spirit my brother (a long time blood donor who passed away, but was an organ donor), I hope you read this and pass it along to ANYONE who might be able to help her.

I have nothing to gain from this except comfort in knowing that I bothered to take a few minutes out of my life to save someone else.

If you can donate, then I am asking you to consider this.

If you cannot donate, then please post to pass it along to anyone who might be able to.

Contact me if you have any questions: patrick@mediligence.com.
Online link to kidney donation questionnaire: https://www.ucsf-kidneytransplant.org/approach/?service=recipient.kidney:recipient.prereq.1#
Tina Mayo

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Top Caseload, Growth through 2020 in Peripheral Stenting http://blog.mediligence.com/2016/04/14/top-caseload-growth-through-2020-in-peripheral-stenting/ Thu, 14 Apr 2016 15:44:23 +0000 http://blog.mediligence.com/?p=9249 Continue reading Top Caseload, Growth through 2020 in Peripheral Stenting]]> Peripheral stenting technologies encompass all vasculature but coronary. We have assessed the volume of all such peripheral stenting procedures through 2020 worldwide.

Peripheral stenting procedures include lower extremity bare metal and drug-eluting stents for treatment of symptomatic periperal artery disease (PAD) and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in chronic venous insufficiency.

In 2015, these peripheral stenting systems were employed in approximately 1.565 million revascularization procedures worldwide, of which the lower extremity arterial stenting accounted for over 80%, followed by abdominal aortic aneurysm (AAA) and thoracic aortic aneurysm (TAA) endovascular repairs and peripheral venous stenting.

Below is illustrated the top geographic areas by caseload for individual peripheral stenting technologies.

Screen Shot 2016-04-14 at 8.32.04 AM

Source: MedMarket Diligence, LLC, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, Report #V201.

Below is illustrated, in order, the top growth areas geographically in peripheral stenting for the period 2015 to 2020. Note that the subtotal of all peripheral stenting products for Asia-Pacific falls within this listing of the top areas of growth in peripheral stenting.

Screen Shot 2016-04-14 at 8.18.55 AM

Source: Report #V201.

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Surgical Sealants, Glues, and Hemostats: Bioactive, Nonactive, Matrices/Scaffolds http://blog.mediligence.com/2016/04/12/surgical-sealants-glues-and-hemostats-bioactive-nonactive-matricesscaffolds-2/ Wed, 13 Apr 2016 02:09:03 +0000 http://blog.mediligence.com/?p=9238 Continue reading Surgical Sealants, Glues, and Hemostats: Bioactive, Nonactive, Matrices/Scaffolds]]> Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

Sealants and glues are emerging as important adjunctive tools for sealing staple and suture lines, and some of these products also are being employed as general hemostatic agents to control bleeding in the surgical field. Manufacturers have also developed surgical sealants and glues that are designed for specific procedures – particularly those in which staples and sutures are difficult to employ or where additional reinforcement of the internal suture/staple line provides an important safety advantage.

Surgical sealants are made of synthetic or naturally occurring materials and are commonly used with staples or sutures to help completely seal internal and external incisions after surgery. In this capacity, they are particularly important for lung, spinal, and gastrointestinal operations, where leaks of air, cerebrospinal fluid, or blood through the anastomosis can cause numerous complications. Limiting these leaks results in reduced mortality rates, less post-operative pain, shorter hospital stays for patients, and decreased health care costs.

Although some form of suturing wounds has been used for thousands of years, sutures and staples can be troublesome. There are procedures in which sutures are too large or clumsy to place effectively, and locations in which it is difficult for the surgeon to suture. Moreover, sutures can lead to complications, such as intimal hyperplasia, in which cells respond to the trauma of the needle and thread by proliferating on the inside wall of the blood vessel, causing it to narrow at that point. This increases the risk of a blood clot forming and obstructing blood flow. In addition, sutures and staples may trigger an immune response, leading to inflamed tissue that also increases the risk of a blockage. Finally, as mentioned above, sutured and stapled internal incisions may leak, leading to dangerous post-surgical complications.

These are some of the reasons why surgical adhesives are becoming increasingly popular, both for use in conjunction with suture and staples and on a stand-alone basis. As a logical derivative, surgeons want a sealant product that is strong, easy-to-use and affordable, while being biocompatible and resorbable. In reality, it is difficult for manufacturers to meet all of these requirements, particularly with biologically active sealants, which tend to be pricey. Thus, for physicians, there is usually a trade-off to consider when deciding whether or not to employ these products.

Surgical sealants, glues, and hemostats can be divided into several different categories based on their primary components and/or their intended use:

  • Products containing biologically active agents (e.g., Baxter Tisseel, Bristol-Myers Squibb Recothrom)
  • Products made from natural and synthetic (nonactive) components (e.g., Baxter CoSeal, Cohera Sylys)
  • Nonactive scaffolds, patches, sponges, putties, powders, and matrices used as surgical hemostats (e.g., Beekin Biomedical NuStat, Equimedical Equitamp)
RevMedX XStat

Drawn from: “Worldwide Surgical Sealants, Glues, and Wound Closure Markets, 2013-2018”, Report #S192.

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Wound management regional growth (“rest of north america”) http://blog.mediligence.com/2016/04/07/wound-management-regional-growth-rest-of-north-america/ Thu, 07 Apr 2016 18:33:06 +0000 http://blog.mediligence.com/?p=9233 Continue reading Wound management regional growth (“rest of north america”)]]> Screen Shot 2016-04-07 at 9.54.16 AM

From Report S251 (see global analysis and the above detail for Americas (with detail for U.S., Rest of North America and Latin America), Europe (United Kingdom, Germany, France, Spain, Italy, and Rest of Europe), Asia/Pacific (Japan, Korea, and Rest of Asia/Pacific) and Rest of World.

Do you wish to see excerpts from “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets”?

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The future (of medicine) is biology http://blog.mediligence.com/2016/03/29/the-future-of-medicine-is-biology/ Tue, 29 Mar 2016 14:14:19 +0000 http://blog.mediligence.com/?p=9214 Continue reading The future (of medicine) is biology]]> It was once quite convenient for manufacturers of deluxe medical widgets to worry only about other manufacturers of deluxe medical widgets. Manufacturers must now widen their perspective to consider current and future competition (and opportunity) from whatever direction it may come. –> Just thought I might chime in and suggest that, if you do make such widgets, it might be a good idea to maybe throw at least an occasional sidelong glance at biotech. (Most of you are, great, but some of you think biotech is too far away to compete…)

Organ Bioengineering is years away and poses little challenge to medical devices …FALSE.  Urinary bladders have been engineered for pediatric applications. Bioengineered skin (the “integumentary” organ) is now routinely bioengineered for burns, chronic wounds, and other wound types. Across a wide range of tissue types (bone, cardiac, smooth muscle, dermal, etc.) scientists — clinicians — have rapidly developed technologies to direct the construction and reconstruction of these tissues and restore their structure and function.

Cell Biology. Of course cells are engineered into tissues as part of the science of tissue engineering, but combine this with advances in engineering not just between cells but between cells AND within cells and (…sound of my head exploding). With the sum of the understanding and capacity to control we have gained over cellular processes over the past few decades now rapidly accelerating, medical science is fast approaching the point at which it can dictate outcomes for cell, tissues, organs, organ systems, and humans (I am not frightened, but excited, with caution).  Our understanding and proficiency gained in manipulating processes from cell division to pluripotency to differentiation to senescence to death OR NOT has profound consequences for fatal, debilitating, incurable, devastating, costly, and nearly every other negative superlative you can conceive.

CRISPR*: This is a new, relatively simple, but extraordinary tool allowing researchers or, more importantly, physicians to potentially swap out defective genes with healthy ones. See Nature.
(* clustered regularly interspersed short palindromic repeats)

Biotech has, over its history, often succeeded in getting attention, but has had less success justifying it, leaving investors rudely awakened to its complexities.  It has continued, however, to achieve legitimately exciting medical therapeutic advances, if only as stepping stones in the right direction, like mapping the human genome, the development of polymerase chain reaction (“PCR”), and biotech-driven advances in molecular biology, immunology, gene therapy, and others, with applications ripe for exploitation in many clinical specialties, Sadly, the agonizing delay between advanced and “available now” has typically disappointed manufacturers, investors, clinicians and patients alike. CRISPR and other tools already available (see Genetic Engineering News and others) are poised to increase the expectations – and the pace toward commercialization – in biotechnology.

Vaccines and Infectious Disease: Anyone reading this who has been under a rock for lo these many years, blissfully ignorant of SARS, Ebola, Marburg, MRSA, and many other frightening acronyms besides HIV/AIDS (more than enough for us already) should emerge and witness the plethora of risks we face (and self-inflict through neglect), any one of which might ultimately overwhelm us if not medically then economically in their impacts. But capitalists (many altruistic) and others have come to the rescue with vaccines such as for malaria and dengue-fever and, even, one for HIV that is in clinicals.

Critical Mass, Synergies, and Info Tech. Biotechnology is succeeding in raising great gobs of capital (if someone has a recommended index/database on biotech funding, let me know?).  Investors appear to be forgetful increasingly confident (in the 1990s, I saw big layoffs in biotech because of ill-advised investments, but that was then…) that their money will result in approved products with protected intellectual property and adequate reimbursement and manageable costs in order to result in attractive financials. The advances in biological and medical science alone are not enough to account for this, but such advances are almost literally being catalyzed by information technologies that make important connections faster, yielding understanding and new opportunities. The net effect of individual medically-related disciplines (commercial or academic) advancing research more efficiently as a result of info tech and info sharing/synergies between disciplines is the expected burst of medical benefits ensuing from biotech. (Take a look also at Internet of DNA.)

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Stents: From Peripheral Arterial to Peripheral Venous http://blog.mediligence.com/2016/03/21/stents-from-peripheral-arterial-to-peripheral-venous/ Mon, 21 Mar 2016 16:56:36 +0000 http://blog.mediligence.com/?p=9198 Continue reading Stents: From Peripheral Arterial to Peripheral Venous]]> Interventional technologies are expanding in all directions and vasculatures. Peripheral stenting as part of endovascular aortic repair or treatment of other symptomatic peripheral artery disease also include bare metal and drug-eluting stents for critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in CVI.

Despite similarities in market dynamics (a notable difference here is the higher growth rate of venous stents)…

Screen Shot 2016-03-21 at 9.36.37 AM

Source: MedMarket Diligence, LLC; Report #V201.

…venous markets have not yet reach the same scale as arterial stents (now shown on the same scale):

Screen Shot 2016-03-21 at 9.35.13 AM

Source: MedMarket Diligence, LLC; Report #V201.

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Venous and Arterial Stents in Peripheral Vascular Applications http://blog.mediligence.com/2016/03/18/venous-and-arterial-stents-in-peripheral-vascular-applications/ Fri, 18 Mar 2016 22:04:43 +0000 http://blog.mediligence.com/?p=9194 Continue reading Venous and Arterial Stents in Peripheral Vascular Applications]]> In the February 2016 report #V201, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, we detail the markets for peripheral stents in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting the abdominal and thoracic aortic tree and lower extremity arterial bed.

Stents are also increasingly used in the management of the debilitating conditions like venous outflow obstruction associated with deep venous thrombosis and chronic venous insufficiency.

Globally, peripheral stenting procedures for arterial indications, as in abdominal and thoracic aortic aneurysm, are growing around 6% annually, while venous procedures are a little higher. More noteworthy is the actual shifts of the market as the slowing, but still relentless, growth in China and elsewhere in Asia-Pacific region is actually changing the balance of markets, and in fact will become the dominant market for peripheral arterial stents by 2020

Periph stent px arterial

Note: Proprietary data obscured.
Source: MedMarket Diligence, LLC; Report #V201.

In the less well developed venous stenting arena, the U.S. and Europe still represent the largest share of the market, and will do so through 2020.

Screen Shot 2016-03-18 at 2.40.34 PM

Note: Proprietary data obscured.
Source: MedMarket Diligence, LLC; Report #V201.

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Bioengineered Skin & Skin Substitutes in Wound Care http://blog.mediligence.com/2016/03/17/bioengineered-skin-skin-substitutes-in-wound-care/ Thu, 17 Mar 2016 15:59:42 +0000 http://blog.mediligence.com/?p=9186 Continue reading Bioengineered Skin & Skin Substitutes in Wound Care]]> Bioengineered skin was developed because of the need to cover extensive burn injuries in patients who no longer had enough skin for grafting. Not so long ago, a patient with third degree burns over 50% of his body surface usually died from his injuries. That is no longer the case. Today, even someone with 90% TBSA has a good chance of surviving. With the array of bioengineered skin and skin substitutes available today, such products are also finding use for chronic wounds, in order to prevent infection, speed healing and provide improved cosmetic results.

apligraf
Apligraf, Organogenesis

Skin used in wound care may be autograft (from the patient’s own body, as is often the case with burn patients), allograft (cadaver skin), xenogeneic (from animals such as pigs or cows), or a combination of these. Bioengineered skin substitutes are synthetic, although they, too, may be combined with other products. It consists of an outer epidermal layer and (depending on the product) a dermal layer, which are embedded into an acellular support matrix. This product may be autogenic, or from other sources. Currently most commercial bioengineered skin is sheets of cells derived from neonatal allogenic foreskin. This source is chosen for several reasons: because the cells come from healthy newborns undergoing circumcision, and therefore the tissue would have been discarded anyway; foreskin tissue is high in epidermal keratinocyte stem cells, which grow vigorously; and because allergic reactions to this tissue is uncommon.

Selected Bioengineered Skin & Skin Substitutes

bio-skin

Source: Exhibit 3-16 in MedMarket Diligence, LLC, Report #S251. To get excerpts, Click Here

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Bioengineered skin displacing traditional wound management products http://blog.mediligence.com/2016/03/16/bioengineered-skin-displacing-traditional-wound-management-products/ Wed, 16 Mar 2016 15:27:59 +0000 http://blog.mediligence.com/?p=9180 Continue reading Bioengineered skin displacing traditional wound management products]]> Very decided shifts are taking place in the wound management market as advanced wound technologies take up caseload from traditional technologies like gauze and others. It becomes evident that traditional products once representing above average sales are now projected to be below average (gauze) as are even a moderately new technology, “negative pressure wound therapy devices” (NPWD), while bioengineered skin and skin substitutes will represent “above average”.

Global Wound Management Market,
Above/Below Average Sectors, 2015 & 2024

Screen-Shot-2016-03-16-at-8.02.29-AM

Source: Report #S251.

Global Wound Management Market, Sales, 2015 & 2024

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Source: Report #S251.

Despite the tepid growth of traditional wound management products, they remain very large markets that even the most aggressively growing segments will require time to match that volume. Bioengineered skin and skin substitutes are moving fast in that direction.

Global CAGR 2016-2024 for Wound Management Segments

Screen-Shot-2016-03-16-at-8.09.10-AM

Source: Report #S251.

If you would like excerpts from this report, Click Here!

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Wound Markets East and West: A Comparison? http://blog.mediligence.com/2016/03/07/wound-markets-east-and-west-a-comparison/ http://blog.mediligence.com/2016/03/07/wound-markets-east-and-west-a-comparison/#respond Mon, 07 Mar 2016 17:11:38 +0000 http://blog.mediligence.com/?p=9168 Continue reading Wound Markets East and West: A Comparison?]]> Placed on the same scale, U.S. markets for wound management technologies do not seem starkly different from those in the Asia/Pacific region, with insignificant differences, now and in the future, in the balance of different technologies used.

Screen Shot 2016-03-07 at 8.50.43 AMScreen Shot 2016-03-07 at 8.50.55 AM

Source: MedMarket Diligence, LLC; Report #S251.

However, one cannot really compare the U.S. and Asia/Pacific on the “same scale” without seeing the obvious differences:

Screen Shot 2016-03-07 at 8.49.54 AMScreen Shot 2016-03-07 at 8.50.28 AM

Source: MedMarket Diligence, LLC; Report #S251. If you would like excerpts from this report, Click Here.

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Peripheral Arterial Disorders http://blog.mediligence.com/2016/03/07/peripheral-arterial-disorders/ http://blog.mediligence.com/2016/03/07/peripheral-arterial-disorders/#respond Mon, 07 Mar 2016 15:37:21 +0000 http://blog.mediligence.com/?p=9163 Continue reading Peripheral Arterial Disorders]]> Excerpt from, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020.” Report #V201.

Within the arterial system, a combination of arteriosclerosis and its progressing form known as atherosclerosis, or obstructive arteriopathy, represents the most common case of PVD. Arteriosclerosis is a normal consequence of aging involving gradual thickening of arterial walls and decline in the number of arterial muscle fibers. As a result, the arteries become rigid and incapable to quickly recoil following expansion or contraction. They also lose the ability to adjust their lumen and accommodate variations in the blood flow dictated by the changing oxygen needs of tissues supplied.

atherosclerosisAtherosclerosis is a pathological complication of arteriosclerosis and not a part of the normal aging experience. It involves a deposition and built-up of plaque composed of fatty substances, cholesterol, cellular waste products, calcium and fibrin (a clotting material in the blood) on the inner lining of arterial wall. In the process of plaque formation, changes also occur to the arterial intima. The trapping of lipids and other harmful matter elicits a low grade inflammatory reaction in the vessels. As these lipids accumulate, occlusion of the vessel lumen results. The artery gradually becomes calcified in the medial layer which, in turns, leads to its stiffening. These conditions interfere with the normal flow of blood through the vessel, and occasionally thrombus formation occurs, which is believed to be caused by the hemorrhage into the plaque and formation of a blood clot on its surface. Such thrombus can fragment and break off to form emboli that travel through the blood stream and often block smaller vessels.

The ultimate causes and triggering mechanisms of atherosclerosis are still to be understood, though, many researchers assume that its onset is directly related to arterial trauma and associated inflammatory processes in the arterial intima. It is also believed that blood platelets play important role in the initiation and progression of the atherosclerotic disease. Platelets are involved in the formation of prostaglandins that might do damage to arteries. They also contain a growth factor that promotes proliferation of smooth muscle cells normally present in the arterial wall. There is a general agreement among practicing clinicians that an elevated and growing platelet count represents one of the earliest and reliable signs of progressing atherosclerosis.

One popular theory asserts the connection between atherosclerosis and excess blood lipoproteins trapped within the artery wall. According to that theory, when sufficient accumulation of such lipoproteins occurs, they become oxidized. The latter presumably leads to formation of some modified lipoproteins that are rapidly taken up by smooth muscle cells. This, in turn, triggers the foam cell forming and deposits of connective tissue cells and other elements.

Still another theory under investigation is focused on possible viral or bacterial cause for atherosclerosis. The advent of this theory has been prompted by the recently found evidence of Chlamydia pneumonia infection in the diseased artery’s plaque.

Although the cited concepts of atherosclerosis seem to have some merit, they tend to suffer from one common deficiency – all of them consider the atherosclerotic disease as a localized phenomenon that is confined in time and space to some site or segment of arterial infrastructure. However, it appears more plausible that atherosclerosis constitutes a local vascular manifestation of a systemic disease, which is associated with some biomolecular and metabolic imbalances and aberrations resulting from the accumulated exposure to ecological, viral, hereditary as well as dietary and other lifestyle factors.

According to the American Heart Association, the common risk factors associated with the development of coronary (and peripheral) atherosclerosis include elevated levels of blood cholesterol (particularly, low density lipoproteins), cigarette smoking, diabetes, hypertension, obesity, physical inactivity, and family history of vascular disease.

XPbtk_hero
Abbott Vascular

Due to largely asymptomatic character of early peripheral atherosclerosis (intermittent claudication, which serves as a primary reason for consulting with a physician, typically occurs in advanced stage of the disease) the available epidemiological data on this vascular disorder are arbitrary and inconclusive. The American Heart Association in its official guidelines on the management of peripheral atherosclerosis states that it afflicts about 5% of all men and 2% of all women aged 50 or older – which adds up to roughly 4.0 million patient caseloads. At the same time, other AHA publications assert that peripheral arterial disorders accompany at least 50% cases of the coronary artery disease and are being discovered in about the same share of all post-mortal exams. On their part, the industry data on the U.S. prevalence of peripheral arterial disease are ranging from 3.5 million cases at the lower end to as high as 25-35 million. Finally, experts in the field generally agree that symptomatic peripheral atherosclerosis affects approximately 8 to 12 million Americans, with about 2.0 million cases of clinically significant cases warranting intervention being diagnosed annually. There are some signs that the incidence of atherosclerosis has been rising during the last decade, reflecting both the aging of the population and continuing expansion of the patient caseloads afflicted by the diabetes, hypertension, and obesity. Arterial vessels of the lower extremities constitute both the most common sites of chronic peripheral vascular occlusions caused by atherosclerosis, and the primary target for interventional treatment with the use of percutaneous transluminal angioplasty (PTA) and stenting techniques.

Aside from their primarily intended uses in recanalization of occluded vascular conduits, covered peripheral stenting devices, or endoluminal stent-grafts are also increasingly employed in less-invasive transcatheter repair (isolation) of rupture-prone aortic aneurysms warranting intervention.

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Growth in advanced wound tech, Germany and Japan http://blog.mediligence.com/2016/03/03/growth-in-advanced-wound-tech-germany-and-japan/ http://blog.mediligence.com/2016/03/03/growth-in-advanced-wound-tech-germany-and-japan/#respond Thu, 03 Mar 2016 17:43:44 +0000 http://blog.mediligence.com/?p=9158 Screen Shot 2016-03-03 at 9.33.34 AM

Source: Report #S251.

 

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Source: Report #S251.

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Growth in wound management from trends in prevalence, technology http://blog.mediligence.com/2016/03/02/growth-in-wound-management-from-trends-in-prevalence-technology/ http://blog.mediligence.com/2016/03/02/growth-in-wound-management-from-trends-in-prevalence-technology/#respond Wed, 02 Mar 2016 20:47:57 +0000 http://blog.mediligence.com/?p=9154 Continue reading Growth in wound management from trends in prevalence, technology]]> Worldwide, an enormous number of wounds are driving a $15 billion market that will soon pass $20 billion. What is driving wound sales is the continued growth and prevalence of different wound types targeted by medical technologies ranging from bandages to bioengineered skin, physical systems like negative pressure wound therapy, biological growth factors, and others.

Most attention in wound management is focused on improving conventional wound healing in difficult clinical situations, especially for chronic wounds, in the expansion of wound management technologies to global markets, and in the application of advanced technologies to improve healing of acute wounds, especially surgical wounds.

Global Prevalence of Wound Types, 2015

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Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.

Total Wound Care Market as Percent of Entire Market, 2024

Screen Shot 2016-03-02 at 12.44.46 PM

Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.


Buy the Executive Summary for “Wound Management to 2024” (purchase price may be applied to subsequent full report purchase):

Or buy the full report:

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