Increasing prevalence of renal diseases is a major factor driving bio-engineered stents market growth. According to American Heart Association Council, in 2015, cardiovascular disease was the leading cause of death worldwide, accounting for over 17.9 million deaths annually and this number is expected to increase to over 23.6 million by 2030. According to the same source, cardiovascular diseases accounted for around 836,546 deaths in the U.S. in 2015, which accounted for around 1 in every 3 deaths.
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Moreover, key players in the market are focused on adopting various strategies such as new Product Type launch and approvals and partnerships and collaborations to increase their foothold in the market. For instance, in May 2017, Medtronic plc., received the U.S. Food and Drug Administration (FDA) approval and Resolute Onyx, 4.5 MM and 5 mm sizes Drug-Eluting Stent. This device has proven clinical performance and superior deliverability of the Resolute Integrity. This device is intended to treat people with coronary artery disease in the U.S.
However, availability of alternatives for the treatment of cardiac diseases, Product Type recalls and failure, and stringent regulations for Product Type approvals are expected to hinder the market growth. For instance in November 2017, Abbott recall Class 1 Device Recall Absorb Bioresorbable Vascular Scaffold (BVS) System, an absorbable coronary drug-eluting stent due to elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.
Key players in the market are focused on launching novel bio-engineered stent in order to reduce thrombus accumulation and address the critical unmet needs of patients in venous access. For instance, in May 2018, Abbott received the U.S. Food and Drug Administration (FDA) approval for XIENCE Sierra, a gold-standard XIENCE everolimus-eluting coronary stent system.
Similarly, in May, 2018, Pursuit Vascular, Inc., received the U.S. FDA clearance for broader indication of its ClearGuard HD caps to include reduction in the incidence of central-line associated bloodstream infection (CLABSI) in hemodialysis patients. In May 2017, Medtronic, Plc. received the U.S. FDA approval for its Resolute Onyx, a 2.0mm size zotarolimus-eluting stent with unique continuous sinusoid technology.
For instance, in February 2016, Maquet Medical Systems, a Getinge Group Company, announced plans to enter into partnership with Biotronik, a Germany-based manufacturer of cardiovascular and endovascular medical devices, to distribute Biotronik’s peripheral vascular devices in the U.S.
According to World Population Prospects, the number of people aged 80 or over is projected to triple by 2050, from 137 million in 2017 to 425 million in 2050 in the U.S. This age bracket is expected to more than double worldwide, increasing from 962 million in 2017 to 2.1 billion in 2050.
Moreover, key players in the market are focused on receiving regulatory approvals for novel products to reduce the burden of blood stream infections associated with bio-engineered stents. For instance, in September 2018, Biotronik SE & Co. KG received the U.S. Food and Drug Administration (FDA) approval for PK Papyrus covered coronary stent system for the treatment of acute coronary artery.
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Major players operating in the global bio-engineered stent market include, Medtronic, plc., Boston Scientific Corporation, Abbott Laboratories, Biotronik SE & Co. KG, B. Braun Melsungen AG, Terumo Corporation, MicroPort Scientific Corporation, Stentys Sao, Meril Life Sciences Pvt. Ltd, Vascular Concepts, W. L. Gore and Associates, C. R. Bard, Endologix, Inc., Lombard Medical Technologies, Translumina GmbH, and JOTEC GmbH.