The Global "Embolic Protection Devices Market" is expected to grow at a high CAGR during the forecasting period (2022-2029).
Embolic protection devices are used for reducing the complications due to debris being released into the bloodstream and causing blockages in smaller vessels. These devices are beneficial for capturing and removing the debris, and emboli from the bloodstream. The market is dominated by the availability of the different types of embolic protection devices such as distal occlusion devices, distal filters, and proximal occlusion devices.
The market is driven by increasing demand for embolic protection devices with the increasing prevalence of cardiovascular, peripheral, and neurovascular diseases. failures. According to the World Health Organization (WHO), approximately 17.9 million people died due to cardiovascular diseases (CVDs) worldwide in 2016. According to the World Heart Federation (WHF), around 15 million people suffer from stroke. There is growing adoption of embolic protection devices for performing artery stenting procedures. Embolic protection devices are widely used in saphenous vein graft (SVG) interventions and carotid artery stenting procedures. The growing usage of minimally invasive surgeries shall stimulate market growth.
There is an increase in the approval of the embolic protection devices. For instance, in March 2020, Keystone Heart had received the CE Mark for the TriGUARD 3 cerebral embolic protection (CEP) device. This device diverts embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. TriGUARD 3 CEP device can accommodate a variety of patient anatomies.
In September 2018, Contego Medical had received the 510(k) clearance from the United States Food and Drug Administration (FDA) for filter-based Integrated Embolic Protection (IEP) device i.e., the Paladin Carotid PTA Balloon System. The Paladin Carotid PTA Balloon System with Integrated Embolic Protection contains an angioplasty balloon and an integrated 40-micron filter. It provides an added measure of protection and procedural flexibility. It allows the physician to adjust the size of the embolic protection filter in vivo to suit each individual patient’s anatomy. It provides optimized micro-embolic protection during the most vulnerable aspects of the procedure. The Paladin System with Integrated Embolic Protection (IEP), is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. It is also used for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material.
The market is witnessing technological advancement for the development of embolic protection devices. For instance, Medtronic has developed Mo. Ma Ultra proximal cerebral protection device. This embolic protection device comprised of the double-occlusion balloon system allows for proximal embolic protection prior to crossing a carotid lesion. The Mo.Ma Ultra proximal cerebral protection device is used to remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the carotid bifurcation.
However, the high rate of embolic protection devices’ failures and recalls is hindering market growth. For instance, in March 2019, Medtronic had recalled the SpiderFX Embolic Protection Devices in the United States. The use of these products has resulted in adverse reactions or quality problems among the patients treated with these products. The lack of proper reimbursement policies for embolic protection devices could have a negative impact on the market.
The embolic protection devices market is segmented based on product type as the distal filter devices, distal occlusion devices, and proximal occlusion devices. The distal filter devices segment accounts for the highest market share of XX% in 2019 due to the higher adoption of the distal filter devices due to their advantages such as ease of use, enhanced visibility, and crossing profile. Distal filter devices are comprised of the basket which is supported by an expandable metal. These devices allow the blood to continue circulating through the filters’ pores. Distal filter devices also allow for contrast media injection during the procedure for lesion and arterial visualization. The distal filter devices provide the non-interference with lesion visualization. These devices are widely available in different specifications.
The distal occlusion systems segment is expected to grow at the highest CAGR over the forecasted period. Distal occlusion systems involve the use of the balloon catheter to temporarily block the flow of blood in a vessel. Distal occlusion systems exhibit several advantages such as low crossing profile and minimum area requirement for the occlusion balloon.
Further, the embolic protection devices market is also classified based on the application as cardiovascular diseases, neurovascular diseases, and peripheral vascular diseases. The cardiovascular diseases segment accounts for the highest market share of XX% in 2019 owing to the higher usage of embolic protection devices for the treatment of cardiovascular diseases. Embolic protection devices are widely used for the treatment of the coronary saphenous vein bypass grafts, & acute coronary syndromes, and performing carotid arterial stenting. Embolic protection devices are useful for preventing major adverse cardiovascular events. These devices are also being preferred for the treatment of the renal arteries and lower extremities.
By region, the embolic protection devices market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the embolic protection devices market due to the higher penetration of the embolic protection devices due to the higher prevalence of cardiovascular diseases, neurovascular diseases, and peripheral vascular diseases. According to the American Heart Association, cardiovascular diseases affect around half of all adults in the United States. According to the Centres for Disease Control and Prevention (CDC), around 18.2 million adults age 20 and older are suffering from coronary heart disease. There is growing adoption of advanced embolic protection devices in hospitals, ambulatory care centers, and others. There is an increase in the number of people undergoing the Trans-Catheter Aortic Valve Replacement (TAVR) procedures. According to the Paul J. Pearson study et.al., 2017 published in the cardiac intervention journal, the number of approved Trans-Catheter Aortic Valve Replacement (TAVR) centers has increased from 156 in 2012 to 511 in 2017. Around 35,000 patients underwent Trans-Catheter Aortic Valve Replacement (TAVR) procedures in the United States in 2016. The high healthcare expenditure for improving the healthcare infrastructure and facilities.
Asia-Pacific is expected to have positive market growth due to the increasing research and development activities for embolic protection devices. There is an increase in the number of market players developing embolic protection devices. Several public and private companies are raising the investment for the development of embolic protection devices. There is growing awareness regarding the use of embolic protection devices. The increasing usage of minimally invasive techniques shall stimulate market growth.
The devices embolic protection market is highly competitive with the presence of several international and local market players. Product diversification, technological advancement, revenue generation, and opportunities intensify the market competition. Medtronic, Abbott Laboratories, Boston Scientific, Contego Medical, W. L. Gore & Associates, Claret Medical, Allium Medical Solutions, and Angioslide are the leading market players with significant market share.
Companies are using novel product launches, technological advancement, new product development, product approval, capacity utilization, and market expansion strategies for holding their position in the market. For instance, in June 2017, Claret Medical had received the de novo clearance for commercializing its Sentinel cerebral protection system (CPS). This system provides the protection from the risk of stroke. It captures and removes debris ejected during transcatheter aortic valve replacement (TAVR) before it reaches the brain. This new embolic protection device is delivered safely and added minimal time to the procedure. It captures the embolic material. It is effective in reducing ischemic brain injury.
In July 2015, Allium Medical had received clearance from the United States Food and Drug Administration (FDA) for Giardia's Wiring system for carotid indication. It is recommended for clinical indication of embolic protection during carotid artery catheterization procedures.
In March 2013, InspireMD, Inc. had received the CE mark approval for the self-expanding Nitinol carotid EPS. This carotid embolic protection stent is based on the proprietary MicroNet mesh protection platform technology used to treat heart attack patients with InspireMD's commercially available coronary EPS stents, MGuard and MGuard Prime.
The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to increase the demand for Embolic Protection Devices and their expansion across the globe. For instance, in August 2019, Cardiovascular Systems (CSI) had acquired the Wirion Embolic Protection System and related assets from Allium Medical Solutions’ wholly-owned Israeli subsidiary Giardia Medical. Wirion System is an easy-to-use distal embolic protection filter is used to capture debris that can be associated with all types of peripheral vascular intervention (PVI) procedures. Wirion can be used with any .014” guidewire and for all types of peripheral interventions and is indicated for use with any atherectomy system.
In July 2018, Boston Scientific had acquired Claret Medical, developer of the Sentinel cerebral protection system. Under the terms of agreement, the transaction price comprised of the $220 million in up-front cash, and potential reimbursement-based milestone payment of up to $50 million.
Several companies are raising the investment and funding for the development of embolic protection devices. For instance, in July 2019, Filterlex Medical had completed the Series A financing round, raising a total of $3 million for its Captis embolic protection device for reducing the risk of stroke and other complications during catheter-based structural heart procedures.
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