Cardiovascular Surgical Procedures, Technologies Trended Globally to 2022

cardiovascular procedures

Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.

Publishing July 2016

This report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).

The report offers current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest-of-the-world.

See the complete table of contents at Report C500.

 

 

Abbott’s fully-absorbing stent gets FDA nod

AbsorbOUS-heroAbbott’s resorbable coronary stent, Absorb, gained FDA regulatory approval today, the first for a fully-dissolving coronary stent. Designed to be fully resorbed by the body within three years of implantation, the device is intended to achieve the endpoint of a more natural vasculature than can be achieved with metal stents.


In July 2016, MedMarket Diligence is publishing, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500.

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.


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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.

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)…

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Source: MedMarket Diligence, LLC; Report #V201.

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

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Source: MedMarket Diligence, LLC; Report #V201.

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.

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

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.

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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.

Common Peripheral Vascular Metal Stent Designs

Conceptually, a stent’s design and architecture are based on the underlying rationale of providing adequate endoluminal scaffolding support of recanalized vascular conduit for a desired period of time, with minimally possible obstruction of normal circulatory flow and propensity to reocclusions associated with healing processes or other plausible causes. Stenting device designs also tend to reflect etiological and anatomical specifics of the targeted occlusive conditions and indications, characteristics of preferred device materials, and technical capabilities of existing manufacturing tools and technologies. 

Common Peripheral Vascular Metal Stent Designs. The vast majority of peripheral vascular stents on the market (which are usually made of metal structural materials) typically feature one of three basic designs: slotted tube, wire mesh, or flattened coil/spiral. The same basic designs are used in non-vascular metallic stents, which in many instances constitute a line extension of corresponding vascular systems.

medtronicstentsThe most popular slotted tube stents – which are cut from tubular metal structures with computer-guided laser and electropolished – are available in several design sub-types including closed-cell flexsegment, open-cell multilink and micromesh versions. Generally, all slotted tube stenting devices combine good radial strength, relatively even distribution of scaffolding support, and minimal foreshortening, and compatibility with low profile delivery systems. The closed-cell flexsegment architecture (usually featuring circumferentially distributed hexagonal, heart, or diamond-shaped cells with one or more common sides) offers enhanced scaffolding and relative lesion coverage at the expense of longitudinal flexibility and kink resistance. open-cell multilink design (with sinusoidal ring-segments and evenly spaced co-axial links/ connectors) provides significantly better longitudinal flexibility (particularly with the use of corrugated links) and more even endoluminal support which come at a price of reduced stent to lesion surface ratio and reduced radiopacity. The micromesh configuration (representing a high-density hybrid version of the close-cell flexsegment and open-cell multilink architectures, with larger number of smaller zigzag cells per ring and closely linked ring segments) approximates the advantageous features of the both designs by offering significant improvement in flexibility over the former one better stent-to-vessel/lesion ratio compared to the latter one.

The wire mesh – featuring unrestricted diamond-shaped cells formed by one or several diagonally interwoven (braided) wire filaments – is arguably the oldest type of metal stent design. High stent-to-vessel/lesion surface ratio, good conformability and even scaffolding, along with technological simplicity and relatively low manufacturing cost constitute the primary benefits of braided wire mesh stenting devices. Unfortunately, such devices are also characterized by a mediocre radial strength, very significant (up to 15%) foreshortening, and poor kink resistance, which radically undercut their utility in critical indications.

Coil or spiral stents (which could be configured as a single or double helix with a flat or flattened wire struts) theoretically offer the best combination of radial strength and longitudinal flexibility. However, spiral devices are also characterized by significant foreshortening, propensity to recoil, and uneven scaffolding support in bended or bending circulatory conduits.

Comparative Advantages and Drawbacks of Most Common Stenting Device Designs

Stent-Design-table-for-blog
Report #V201 (February 2016)

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

Arterial and Venous Peripheral Stenting in AAA, TAA, Chronic Venous Insufficiency, Others

Critical limb ischemia, aortic aneurysm, chronic venous insufficiency and other pathologies continue to represent vertical and horizontal opportunities for medtech manufacturers, with expanded clinical applications and global growth, according to MedMarket Diligence.

“Peripheral arterial and venous vessel pathologies reduce the quality of life and can be fatal, but medtech manufacturers have developed highly effective peripheral stents, using core platform technologies often developed in parallel with those for coronary applications,” says Patrick Driscoll of MedMarket Diligence. These pathologies include the most prevalent occlusive circulatory conditions affecting the abdominal and thoracic trees (including aortic aneurysm) and lower extremities as well as the venous outflow conditions, deep venous thrombosis and chronic venous insufficiency.

“By 2020, these pathologies will produce over 2 million interventions annually worldwide, arising from opportunities for improved performance in challenging vasculature as well as from the growing economies, especially China, in the Asia-Pacific region,” says Driscoll, who notes that venous stenting’s very large potential patient caseload opportunity is of particular interest to a number of key medtech players who have already taken steps toward seizing it.

Peripheral stenting systems are used for the management of occlusive disorders and other pathologies affecting peripheral arterial and venous vasculature. These include lower extremity bare metal and drug-eluting stents for treatment of symptomatic peripheral artery disease 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 CVI.

For more information, see “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, contact reports@mediligence.com or call +1.949.891.1753.

Peripheral Stents Taking on New Caseload, Markets, According to New MedMarket Diligence Report

FOOTHILL RANCH, Calif. – February 17, 2016 – Peripheral stents — the use of specific devices to maintain the patency of arterial and venous blood vessels outside of the heart – will account for over $4.6 billion in worldwide sales by 2020. Critical limb ischemia, aortic aneurysm, chronic venous insufficiency and other pathologies continue to represent vertical and horizontal opportunities for medtech manufacturers, with expanded clinical applications and global growth. MedMarket Diligence has assessed the products, technologies, and global markets for peripheral stenting systems in the 2016 report, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020.”

“Peripheral arterial and venous vessel pathologies reduce the quality of life and can be fatal, but medtech manufacturers have developed highly effective peripheral stents, using core platform technologies often developed in parallel with those for coronary applications,” says Patrick Driscoll of MedMarket Diligence. These pathologies include the most prevalent occlusive circulatory conditions affecting the abdominal and thoracic trees (including aortic aneurysm) and lower extremities as well as the venous outflow conditions, deep venous thrombosis and chronic venous insufficiency.

“By 2020, these pathologies will produce over 2 million interventions annually worldwide, arising from opportunities for improved performance in challenging vasculature as well as from the growing economies, especially China, in the Asia-Pacific region,” says Driscoll, who notes that venous stenting’s very large potential patient caseload opportunity is of particular interest to a number of key medtech players who have already taken steps toward seizing it.

MedMarket Diligence’s report, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020″, covers the universe of stenting systems intended for the management of occlusive disorders and other pathologies affecting peripheral arterial and venous vasculature. These include lower extremity bare metal and drug-eluting stents for treatment of symptomatic peripheral artery disease 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 CVI.

The report details the global healthcare market for arterial and venous stenting in peripheral blood vessels, including the epidemiology and etiology of peripheral vascular conditions; current and forecast procedure volumes; current and emerging clinical practices employing bare metal stents, drug-eluting stents, stent-grafts for abdominal aortic aneurysm and thoracic aortic aneurysm; products and technologies on the market and in development; global competitor market shares by device type; the global and regional markets; and profiles of key active companies.

The report is described in detail including a complete table of contents and list of exhibits at http://mediligence.com/rpt/rpt-v201.htm. The report may be purchased for immediate download from https://mediligence.com/store/peripheral-stents-2015.html or via order form (http://mediligence.com/order_forms/v201_order.pdf).

For details, contact reports@mediligence.com

MedMarket Diligence, LLC
26071 Portola Parkway
Suite 1E
Foothill Ranch, CA 92610
www.mediligence.com

 

 

 

 

Peripheral Stents Heading to Far East

Stents, still a common clinical option in coronary ischemia, have migrated peripherally anatomically and far eastward geographically. Their use in peripheral applications is gaining speed, particularly outside western markets.

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Source: MedMarket Diligence, LLC; Report #V201

U.S. and Western European markets have longer history in the use of stents in peripheral arterial and venous stents, but Japan, India, and China have proven their capacity for demand in medtech.

Peripheral stents in global markets are the subject of the MedMarket Diligence, LLC, report (#V201), “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”.

The scope of market analysis of the MedMarket Diligence report #V201 is the universe of stenting systems intended for the management of occlusive disorders and other pathologies affecting peripheral arterial and venous vasculature. The cited systems include lower extremity bare metal and drug-eluting stents for treatment of symptomatic 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 CVI.