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.

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

 

Peripheral arterial and venous stenting forecast

MedMarket Diligence is publishing within the next two weeks its 2016 report on peripheral stents for arterial and venous applications. The report is entitled, “Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast to 2020”, and is described in detail at link.

Source: MedMarket Diligence, LLC; Report #V201

Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast 2020

Publishing December 2015

Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast 2020. Report #V201 (for details, see link, or ordering see link).

This report presents a worldwide market analysis of products and technologies used in the markets for peripheral arterial and venous stenting.

The report will provide full year (actual) 2014 market size and share data, with forecast market data to 2024, for the U.S., Europe (with detail for United Kingdom, Germany, France, Spain, and Italy), and Asia/Pacific (with detail for China, India and Japan).

Executive Summary

Section 1: Global Healthcare Environment

1.1 United States

1.2 Largest Western European States

1.2.1 France

1.2.2 Germany

1.2.3 Italy

1.2.4 Spain

1.2.5 United Kingdom

1.3 Major Asian-Pacific States

1.3.1 China

1.3.2 India

1.3.3 Japan

Section 2: Existing and Emerging Peripheral Stenting Technologies – An Overview

2.1 Bare Metal Stenting Systems

2.1.1 Structural materials, design, architecture, deployment mechanisms

2.2 Drug-Eluting Stenting Systems

2.2.1 Structural materials, design, architecture, anti-restenotic drugs, drug coating and delivery mechanisms

2.3 Covered Stents and Stent-Grafts

2.3.1 Structural materials, design, architecture, delivery routes, deployment and fixation mechanisms

Section 3: Primary Clinical Applications of Peripheral Stenting

3.1 Lower Extremity Arterial Occlusions and Renal Artery Stenosis

3.1.1 Incidence, Prevalence, Established Treatment Modalities

3.1.2 Accumulated Clinical Experience with Stenting

3.1.3 Lower Extremity and Renal Stenting Procedure Volumes

3.2 Chronic Venous Insufficiency and Venous Outflow Obstructions

3.2.1 Incidence, Prevalence, Established Treatment Modalities

3.2.2 Accumulated Clinical Experience with Venous Stenting

3.3 Rupture-Prone Aortic Aneurysms and Dissections

3.3.1 Incidence, Prevalence, Established Treatment Modalities

3.3.2 Accumulated Clinical Experience with Aortic Endografts

3.2.3 Endovascular Aortic Aneurysm (Dissection) Repair Procedure Volumes

Section 4: Worldwide Markets for Peripheral Arterial and Venous Stenting Systems

4.1 Lower Extremity and Renal Arterial Stenting Systems

4.1.1 Industry Product Offering

4.1.2 Market Forecast

4.1.2.1 Competitive Analysis

4.2 Venous Stenting Systems

4.2.1 Industry Product Offering

4.2.2 Market Forecast

4.2.2.1 Competitive Analysis

4.3 AAA and TAA Repair Endograft Systems

4.3.1 Industry Product Offering

4.3.2 Market Forecast

4.3.2.1 Competitive Analysis

Section 5: Company Profiles

5.1 Abbott Vascular (Abbott Laboratories)

5.2 Alvimedica

5.3 AMG international

5.4 Andramed

5.5 Bard Peripheral (C.R. Bard)

5.6 Bentley Innomed

5.7 Biotronik

5.8 Biosensors International

5.9 Boston Scientific

5.10 Cook Medical (Cook Group)

5.11 Cordis (Cardinal Medical)

5.12 Endologix

5.13 Gore & Associates

5.14 Jotec GmbH

5.15 Lifetech Scientific

5.16 Lombard Medical

5.17 Maquet Vacular

5.18 Medtronic

5.19 OptiMed

5.20 QualiMed Innovative

5.21 TriVascular

5.22 Vascutek (Terumo)

5.23 Veniti


Global Market Opportunities in Peripheral Arterial and Venous Stents, Forecast 2020. Report #V201.

For details, including updated table of contents, see link.
For ordering all options, including PDF, Print, site license and global license, see link). Publishing December 2015.

Order “Peripheral Stents 2015” (report #V201) online to receive the $500 advance discount (until publication)  on the PDF edition: