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

 

Technologies at Medtech Startups, January 2016

Below are technologies under development at startups recently identified and included in the Medtech Startups Database.

  • Breast cancer detection.
  • Technologies in cardiac surgery, neuromodulation, and cardiac rhythm management.
  • Technologies for minimally invasive laminoplasties, foraminoplasties, and implantables in spine surgery.
  • Xenogenically-sourced tissue matrices for soft tissue, regenerative, and vascular applications.
  • Device to clean trocar during laparoscopic procedures.
  • Pressure sensors in catheterization/angiography.

For a comprehensive listing of the technologies under development at startups identified since 2008, see link.

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

Forecasts for neurointerventions in acute stroke

Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.

In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.

Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.

Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.

Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).

Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.

Source: MedMarket Diligence, LLC; Report #C310.

 

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:
  

 

 

Acute Stroke Therapeutics and a $1.7+ Billion Neurointerventional Worldwide Market; MMD Report

Stroke is a costly condition with a growing patient population targeted neurointerventional treatments that will account for hundreds of millions in sales over the next five years, according to a recent MedMarket Diligence report.

Acute stroke therapeutics are focused almost exclusively on patients’ cardiopulmonary and hemodynamic support and ad hoc containment of dangerous complications and corresponding brain damage associated with stroke. Among the life-threatening complications that commonly accompany acute cerebral hemorrhage or ischemia are cerebral edema; hydrocephalus; brain stem compression; vasospasm and pulmonary embolism. These therapeutic technologies will account for $323 million in new revenue from 2015 to 2019, according to the recently published MedMarket Diligence report, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, details

“Stroke is associated with costly long-term care, especially for a patient population that is typically older and more susceptible to its complications, but neurointerventional treatment have succeeded in both making a positive clinical impact and securing respectable revenue streams for manufacturers,” says Patrick Driscoll of MedMarket Diligence. These technologies will continue to develop and improve over the next five years, but much growth will also come from the penetration by these technologies in non-U.S. markets, where relative use is lower and shows untapped potential.

Stroke is a life-threatening medical condition characterized by a sudden catastrophic breakdown in the brain-supporting cerebrovascular system and blood supply, which, in many instances, is followed by an irreversible injury to the brain cells and severe neurological impairment or death.

Notwithstanding the remarkable progress in medical science and technology and associated improvements in clinical practices, stroke continues to constitute the major public health problem in the U.S. and overseas.

The $1.5 billion global market for acute stroke management is revealed in detail in the MedMarket Diligence report #C310, “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, (see http://mediligence.com/rpt/rpt-c310.htm). The report is a detailed market and technology assessment and forecast of the products and technologies in the management of acute stroke. The report describes the epidemiology, etiology and management of hemorrhagic stroke, ischemic stroke, subarachnoid hemorrhage, and transient ischemic attack, characterizing the patient populations, their current clinical management, and trends in clinical management as new techniques and technologies are expected to be developed and emerge. The report details the currently available products and technologies, and the manufacturers offering them. The report details the products and technologies under development and markets for each in the treatment of acute stroke. The report provides a current and forecast to 2019 by region /country for the U.S., Western Europe, the major Asia-Pacific states (China, India, and Japan), and the rest of world. The report profiles the most top companies in this industry, providing status and forecast data on their current products, current market position, and products under development.

The report is described in detail at http://mediligence.com/rpt/rpt-c310.htm and may be ordered for immediate download from https://www.mediligence.com/store/page54.html.

 

Three Key Forces Behind Startups and Investment in Medical Technology

We see three key forces underlying investment trends in medical technology:

  • The spectrum of competition has been broadened and sometimes isn’t even obvious.

Widely different technologies (as in treatment of coronary artery disease, see white paper) can address a clinical condition, with the solution to the problem being the focus of new investment.

New materials for devices, drug-device hybrids, biotech-driven solutions, and other innovations can create competition between very different technologies. As a result, the paradigms and truths that held true in the past, when devices only went head-to-head with devices, are no longer relevant, creating the need to better assess the competitive landscape.

Manufacturers must there develop good market awareness, as in being cognizant of all the potential source of competition, such as from companies in adjacent markets who might pivot and seize market share.

  • Money flows to niches in medtech where the demand for clinical utility is high.

The biggest forces driving medtech are increasing patient populations or the cost of managing them. Niches that address the challenges of an older population with unsolved painful and or costly conditions (orthopedics, chronic wounds, diabetes, bariatrics) have prominent cost targets that stimulate investment.

Patient demographics, healthcare cost/utility demands and other forces make some medtech niches very attractive, even if only as a result of technology migration (e.g., to growth geo markets).

  • Underserved patient populations command almost as much attention as the untapped patient populations.

There is much potential return on investment to be made in blockbuster treatments, but these can be financial sinkholes compared to less grandiose technology solutions. A motive force exists in medtech, centered around healthcare costs, that is relentlessly forcing medical technology innovators to find opportunity within existing markets, by eliminating cost (e.g., shifting care to outpatient as via minimally invasive technologies). Significant medical technology investment has already recognized the value in targeting conditions for which new technology, new clinical practices and/or simply new ways of thinking can improve the quality of life, patient costs or both.

Medtech investment is most serious when it is (1) in high dollar value, or (2) tied to the formation of companies. It reflects confidence in that sector to the degree set by the investment.

In the past five years, MedMarket Diligence has tracked the identification of over 600 companies in medtech. Below is the distribution of their focus across a large number of clinical and technology areas (multiple possible, as in “minimally invasive” and “orthomusculoskeletal”).

These companies have also been tracked through their specific investments (detailed historically at link).

Source: MedMarket Diligence, LLC; Medtech Startups Database.

Cardiology, orthopedics, and surgery are mainstay drivers of new technology development in medtech, as has been the push for minimally invasive therapies, but nanotechnology, interventional (e.g., transcatheter) technologies, biomaterials, wound management and other niches have a steady stream of new company formations.


See recent reports from MedMarket Diligence in the following clinical areas.

Technologies in Development at Medtech Startups, October 2015

In our flurry of activity in October, we overlooked summarizing the new medical technologies identified at startups and added to the Medtech Startups Database:

  • Neodymium vaginal dilator for treatment of pelvic pain.
  • Large bore, power injection vascular access
  • Surgical instruments for use in bariatrics.
  • Surgical oncology.
  • Spine surgical technology including expandable intervertebral cage.
  • Technologies to treat hearing loss.
  • Device to determine blood vessel size.
  • Cerebrospinal fluid shunt.
  • Focused ultrasonic surgical devices for hemostasis, cauterization, and ablation.
  • Collagen polymers to create 3D tissue systems for drug discovery, engineered tissue/organ, wound management, and 3D bioprinting.
  • Regenerative medicine to treat brain injury or damage.
  • Neuro-monitoring and neuro-critical care.
  • Orthomusculoskeletal implants.
  • Devices and methods for hip replacement
  • Intraoperative image system.
  • Exocentric medical device
  • Electro-hydraulic generated shockwave for cosmetic, medical applications.

For a historical listing of technologies at medtech startups, see link.

Technologies in Development at Medtech Startups, November 2015

Below is a list of the technologies under development at new medtech companies and recently added to the Medtech Startups Database.

  • Devices to assist pulmonary function.
  • Technologies to improve performance of orthopedic implantation.
  • Treatments for conditions associated with spinal cord injury and disease.
  • Technologies for the preservation and transport of organs and biologicals.
  • Interventional technologies for the treatment of neurovascular technologies.
  • Spinal fusion technologies
  • Orthopedic implants, including a prosthetic meniscus for placement in the knee joint.
  • Women’s health products including low risk device to measure cervical dilation.
  • Medical device to rapidly and accurately diagnose otitis media.
  • Bioabsorbable heart valve.
  • Electro-hydraulic generated shockwave for cosmetic, medical applications.

For a historical listing of technologies at medtech startups, see link.