advanced medical technologies http://blog.mediligence.com insights, perspectives and inside data from medtech market analysis at MedMarket Diligence, LLC Thu, 05 May 2016 16:36:25 +0000 en-US hourly 1 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

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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.

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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.

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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)…

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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.

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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.

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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

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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

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


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Common Peripheral Vascular Metal Stent Designs http://blog.mediligence.com/2016/02/22/common-peripheral-vascular-metal-stent-designs/ http://blog.mediligence.com/2016/02/22/common-peripheral-vascular-metal-stent-designs/#respond Mon, 22 Feb 2016 16:05:33 +0000 http://blog.mediligence.com/?p=9148 Continue reading 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

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Report #V201 (February 2016)

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

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Arterial and Venous Peripheral Stenting in AAA, TAA, Chronic Venous Insufficiency, Others http://blog.mediligence.com/2016/02/19/arterial-and-venous-peripheral-stenting-in-aaa-taa-chronic-venous-insufficiency-others/ http://blog.mediligence.com/2016/02/19/arterial-and-venous-peripheral-stenting-in-aaa-taa-chronic-venous-insufficiency-others/#respond Fri, 19 Feb 2016 14:46:16 +0000 http://blog.mediligence.com/?p=9141 Continue reading 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.

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Peripheral Stents Taking on New Caseload, Markets, According to New MedMarket Diligence Report http://blog.mediligence.com/2016/02/17/peripheral-stents-taking-on-new-caseload-markets-according-to-new-medmarket-diligence-report/ http://blog.mediligence.com/2016/02/17/peripheral-stents-taking-on-new-caseload-markets-according-to-new-medmarket-diligence-report/#respond Wed, 17 Feb 2016 21:46:38 +0000 http://blog.mediligence.com/?p=9139 Continue reading 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

 

 

 

 

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Peripheral Stents Heading to Far East http://blog.mediligence.com/2016/02/16/peripheral-stents-heading-to-far-east/ http://blog.mediligence.com/2016/02/16/peripheral-stents-heading-to-far-east/#respond Wed, 17 Feb 2016 00:23:39 +0000 http://blog.mediligence.com/?p=9135 Continue reading 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.

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Peripheral Vascular Stenting to 2020 http://blog.mediligence.com/2016/02/10/peripheral-vascular-stenting-to-2020/ http://blog.mediligence.com/2016/02/10/peripheral-vascular-stenting-to-2020/#respond Wed, 10 Feb 2016 16:16:23 +0000 http://blog.mediligence.com/?p=9126 Continue reading Peripheral Vascular Stenting to 2020]]> First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications within non-coronary vasculature.

Today, peripheral vascular stenting techniques are commonly employed in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting 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.

Peripheral vascular 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.

In 2015, these peripheral stenting systems were employed in ovet 1.5 million revascularization procedures worldwide, of which lower extremity arterial stenting accounted for 81% of such interventions, followed by abdominal aortic aneurysm and thoracic aortic aneurym endovascular repairs.

Clinicians in the U.S. performed 34.1% of worldwide covered peripheral arterial and venous procedures,  followed by the major Western European countries (33.1%), major Asian-Pacific states (24.4%), and the rest-of-the-world with 8.4% of peripheral stent-based interventions.

During the forecast period, the global volume of peripheral arterial and venous stenting procedures is projected to grow an average of 5.5% and 6.2% per annum, generating over $4,620 million in cumulative product revenues in the year 2020.

The largest relative and absolute dollar gains in all covered product segments can be expected in Asian-Pacific market geography based on rapid transition to modern interventional radiology practices and availability of funding in China. Similar, but somewhat slower growth trends might be observes in the ROW zone, albeit from a much lower base.

Highly mature U.S. and Western European markets are likely to register relatively modest advances both in corresponding procedure volumes and device sales.

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Source: MedMarket Diligence, LLC; Report #V201, “Global Market Opportunities in Peripheral Arterial and Vascular Stents, Forecast to 2020” publishing February 2016).

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Source: MedMarket Diligence, LLC; Report #V201

 

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