Compliance with New EU-MDR May Lead to Shortage of Medical Devices amidst COVID-19 Crisis

The European Parliament recently announced the postponement of the implementation of the new Medical Device Regulation (MDR) by a year, due to the unprecedented COVID-19 (coronavirus) outbreak. This will help medtech companies in the vascular closure devices market to stabilize their operations, owing to the debilitating consequences of the pandemic. This postponement is to come in practice after individual member states share their approval. However, the COVID-19 crisis has slowed down innovations in the vascular closure devices market and postponement of the regulations is anticipated to affect the growth rate of the market.

Given the current pressure on the national health authorities, popular news outlets state that compliance with new regulations could create a shortage and delay in the supply of medical devices in Europe. Hence, the postponement of the new Medical Device Regulation (MDR) will help medical device manufacturers to meet urgent demands in healthcare facilities caused due to the COVID-19 outbreak.

vascular closure devices market infographic

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Biomechanical Vascular Closure Devices Overcome Limitations in Closure of Large Bore Femoral Arteriotomies

Specialty-focused solutions are acquiring prominence in the vascular closure devices market. For instance, leading supplier of specialty medical devices for critical care and surgery Teleflex, announced to showcase their MANTA® vascular closure device at the 2019 PCR London Valves-a cross-disciplinary course being held in London, U.K. Specialty-focused solutions are helping healthcare providers to improve the health and patient quality of life worldwide. Companies are increasing efforts to develop products that simplify complex procedures and overcome barriers associated with common procedural challenges.

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Novel biomechanical vascular closure devices (VDCs) are boosting the credibility of companies in the market landscape. These devices are being pervasively used by interventionalists worldwide for the closure of large bore femoral arteriotomies. Companies in the vascular closure devices market are designing products that seal arterial puncture holes post percutaneous coronary intervention (PCI) catheter-based vascular procedures. As such, the revenue of peripheral vascular interventions is anticipated for robust growth during the forecast period.

Devices with Biocompatible Stainless Steel Implants Gain Prominence in Intra-Arterial Procedures

Companies in the vascular closure devices market are investing in capacity additions to manufacture products used to close femoral arteriotomies following intra-arterial procedures. This explains why cardiac interventions dictate the highest revenue among all applications in the vascular closure devices market, since these devices are being increasingly used in peripheral and coronary angioplasty, owing to the high prevalence of cardiovascular diseases worldwide. As such, the market is estimated to reach a value of ~US$ 1 Bn by the end of 2027.

Other important applications demanding vascular closure devices are other intra-arterial procedures such as arterial stents, balloon angioplasty, and diagnostic or interventional catheterization procedures. Hence, companies in the vascular closure devices market are increasing their production capabilities to manufacture biocompatible stainless steel implants. They are increasing R&D to design implants that can be applied both inside and outside of the puncture site in the femoral artery.

Improved Suture-based Techniques Aid in Challenging Procedures of Final Vascular Closures

Suture-based closure devices are being adopted by healthcare professionals for percutaneous closure of large-bore arteriotomies. Such advancements are boosting the growth for the vascular closure devices market, which is predicted to grow at a robust CAGR of ~7% during the forecast period. However, suture-based closure devices are cumbersome and are experiencing a downtick, owing to their long learning curve and increased risk of complications. Hence, companies in the vascular closure devices market are increasing their efforts to design devices that are used in parallel or angulated configuration.

Prominent medical devices and healthcare company Abbott is increasing awareness about Perclose ProGlide-an improved suture-based vascular closure device, which is being frequently used in large-bore vessel closures. Advanced vascular closure devices are performing in challenging procedures such as suture knots that are advanced to the vessel wall for final vascular closures. Recent trends include single-device deployment in hybrid closure techniques. On the other hand, dedicated large-bore closure devices are overcoming limitations of surgical and suture-based closure techniques.

vascular closure devices market segmentation

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Analysts’ Viewpoint

Europe dominates the second-highest revenue among all regions in the vascular closure devices market, but is challenged with urgent needs, owing to the COVID-19 pandemic, which is relatively severe in European countries. As such, the postponement of the new EU-MDR will help medtech companies to stabilize their operations over the next few months and prevent shortage of medical devices.

Though suture-based techniques form the current standard of care, these techniques remain technically demanding for inexperienced healthcare operators and are relatively time consuming. Hence, companies should increase the availability of dedicated large-bore devices that overcome the drawbacks associated with suture-based closure devices.

Vascular Closure Devices Market: Overview

  • This report analyzes the current scenario and future growth prospects of the global vascular closure devices market
  • The report provides an elaborate executive summary, which provides a snapshot of various segments of the global market. It also provides information and data analysis of the global vascular closure devices market with respect to segments based on product, access type, application, end user, and region.
  • The overview section of the report provides a detailed qualitative analysis of drivers, restraints, and opportunities that impact the global vascular closure devices market
  • The report includes company profiles, which provide information about business strategies, product portfolios, and financials of players operating in the global vascular closure devices market and competitive landscape of the market
  • The report on the global vascular closure devices market offers attractiveness analysis of different segments of the market across regions
  • The last section of the report comprises quantitative and qualitative analysis on market share/position of key players operating in the market. It analyzes key competitive strategies adopted by major market players, thereby presenting a thorough understanding of the competition scenario in the global vascular closure devices market.

Vascular Closure Devices Market: Key Segments

  • In terms of product, the market has been segmented into passive approximators, active approximators, and external hemostatic devices. The passive approximators segment is further categorized into collagen plugs, sealant or gel-based devices, and compression-assist devices. The active approximators segment is further categorized into suture-based devices and clip-based devices.
  • The passive approximators segment dominated the market in 2018 and the trend is projected to continue during the forecast period, owing to extensive use of these devices for vessel closure
  • Based on access type, the market has been classified into femoral access and radial access. The femoral access segment accounted for the largest market share in 2018. The femoral access segment projected to dominate the market during the forecast period due to increase in availability of femoral access site closure devices.
  • In terms of application, the global market has been categorized into cardiac interventions cerebrovascular interventions, peripheral vascular interventions, and others. The cardiac interventions segment is dominated in 2018 and expected to continue its growth during the forecast period, owing to an increase in prevalence of cardiovascular diseases. As per the American Heart Association estimates, more than 130 million adults are likely to suffer from cardiovascular disorders in the U.S. by 2035.
  • In terms of end user, the global market has been divided into hospitals, ambulatory surgical centers, and cardiac catheterization laboratories. The hospitals segment is likely to continue its dominance during the forecast period due to increase in number of cases heart disease and related complications.
  • Market size and forecast for each of the segments of the global vascular closure devices market have been provided for the period from 2017 to 2027. The CAGRs of the segments of the global vascular closure devices market have also been provided for the period from 2019 to 2027, considering 2018 as the base year.

Vascular Closure Devices Market: Regional Outlook

  • In terms of region, the global vascular closure devices market has been segmented into North America (U.S. and Canada), Europe (U.K., Germany, Spain, Italy, France, and Rest of Europe), Asia Pacific (China, India, Japan, Australia & New Zealand, and Rest of Asia Pacific), Latin America (Brazil, Mexico, and Rest of Latin America), and Middle East & Africa (GCC Countries, South Africa, and Rest of Middle East & Africa). Each region of the global market has been divided into major countries/sub-regions.
  • The report provides the size and forecast of the market in each region and country/sub-region for the period from 2017 to 2027. The CAGR of the market in each of these regions and countries/sub-regions has also been provided for the period from 2019 to 2027. The study also covers the market competition scenario in these regions.
  • Continuous focus on quality management, increase in number of healthcare providers opting for vascular closure devices, and rise in prevalence of lifestyle diseases leading to cardiac arrest & other heart diseases are expected to boost the growth of the market in North America

Companies Covered in Vascular Closure Devices Market Report

  • Key players in the global vascular closure devices market have been profiled based on attributes such as company overview, product portfolio, financial overview, recent developments, and competitive business strategies
  • Major companies profiled in the global vascular closure devices market report are 
    • Terumo Medical Corporation
    • Cardinal Health
    • Abbott
    • Cardiva Medical, Inc.
    • Medtronic plc
    • BIOTRONIK
    • Teleflex Incorporated
    • Tricol Medical
    • Merit Medical Systems, Inc.
    • Z-Medica, LLC

Vascular Closure Devices Market - Scope of the Report

TMR’s report on the global vascular closure devices market studies the past as well as current growth trends and opportunities to gain valuable insights of these indicators for the market during the forecast period from 2019 to 2027. The report provides the revenue of the global vascular closure devices market for the period 2017–2027, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global vascular closure devices market for the forecast period.

The report has been prepared after an extensive research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Extensive secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global vascular closure devices market.

Secondary research also included internet sources, statistical data from government agencies, websites, and trade associations. Analysts have also employed a combination of the top-down and bottom-up approaches to study various phenomena in the global vascular closure devices market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Furthermore, the report sheds light on the changing competitive dynamics in the global vascular closure devices market. These indices serve as valuable tools for existing market players as well as for entities interested in participating in the global vascular closure devices market. The next section of the global vascular closure devices market report highlights the USPs, which include regulatory scenario by region/globally, technological advancements and key industry events (mergers, acquisitions, new service launch, etc.)

The report delves into the competitive landscape of the global vascular closure devices market. Key players operating in the global vascular closure devices market have been identified, and each one of these has been profiled for their distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players profiled in the global vascular closure devices market report.

Key Questions Answered in Vascular Closure Devices Market Report

  • What are the major drivers, restraints, and opportunities in the global market?
  • What are the revenue share projections of key segments of the global vascular closure devices market during the forecast period?
  • Which segment is likely to lead the global vascular closure devices market in terms of revenue by 2027?
  • How alliances & partnerships among players are widening the scope of the global vascular closure devices market?
  • What is the market position of different companies operating in the global vascular closure devices market?

Vascular Closure Devices Market - Research Objectives and Research Approach

The comprehensive report on the global vascular closure devices market begins with an overview of the market, followed by the scope and objectives of this study. Following this, the report provides detailed explanation of the objectives behind this study and healthcare compliances laid down by accredited agencies in the purview of research on the global vascular closure devices market. It is followed by market introduction, market dynamics, and an overview of the global vascular closure devices market, which includes TMR analysis of market drivers, restraints, and trends affecting the growth of the global vascular closure devices market. Furthermore, Y-o-Y analysis with elaborate insights has been provided to understand the Y-o-Y trends in the global vascular closure devices market. The next section of the global vascular closure devices report highlights the USPs, which include regulatory scenario by region/globally, epidemiology of cardiovascular diseases, technological advancements and key industry events (mergers, acquisitions, new service launch, etc.)

For reading comprehensibility, the report has been compiled in a chapter-wise layout, with each section further divided into smaller ones. The entire report comprises an exhaustive collection of graphs and tables that are appropriately interspersed in the entire compilation. Pictorial representation of actual and projected values of key segments is visually appealing to readers. This also allows comparison of the market shares of key segments in the past and at the end of the forecast period.

The report analyzes the global vascular closure devices market in terms of product, access type, application, end user, and region. Key segments under each criteria have been studied at length and the market share for each of these at the end of 2027 has been provided. Such valuable insights enable market stakeholders in making informed business decisions for investments in the global vascular closure devices market.

Vascular Closure Devices Market - Segmentation

Product

  • Passive Approximators
    • Collagen Plugs
    • Sealant or Gel-based Devices
    • Compression-assist Devices
  • Active Approximators
    • Suture-based Devices
    • Clip-based Devices
  • External Hemostatic Devices

Access Type

  • Femoral Access
  • Radial Access

Application

  • Cardiac Interventions
  • Cerebrovascular Interventions
  • Peripheral Vascular Interventions
  • Others

End User

  • Hospitals
  • Ambulatory Surgical Centers
  • Cardiac Catheterization Laboratories

Region

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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