The prosthetic heart valve offers excellent valve function and works in coordination with the entire circulatory system to protect each part from damage. There are many kinds of technologies for prosthetic heart valves, which includes anti-calcification, sutureless valves, polymers, and carbon-based technologies. An anticalcification technology is more common technology that may irreversibly choke calcium binding sites in bioprosthetic valves and protect the bioprosthetic valves from deterioration. In February 2016, the U.S. FDA approved a new technology called sutureless aortic valve replacement that is used for treatment of aortic valve disease.
Many adults worldwide battle against conditions such as valvular heart disease and aortic stenosis, the narrowing of the aortic valve. In fact, aortic stenosis is the world’s most common non-congenital valve disease. According to NCBI, 2014, Rheumatic heart disease continues to affect millions of children and young adults in the Indian subcontinent with prevalence rates as high as 51 per 1000 population. So continuous advancements in surgical replacement technologies for patients with damaged, diseased or malfunctioning heart valves by manufacturers, is likely to fuel the demand of these devices substantially over the next few years. For instance, in 2016, St. Jude Medical Inc. launched the advanced tissue valve—the Trifecta valve with Glide Technology (GT)—for the treatment of patients with unhealthy, damaged or malfunctioning aortic heart valves in U.S. This Trifecta GT tissue valve offers patients enhanced valve delivery to ease implantation in challenging anatomies and during minimally invasive surgical approaches.
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The aging population and increasing patient population of heart disease are expected to drive demand for prosthetic heart valve-based treatment in the future. For instance, According to the statistics of World Health Organization in 2012, 17.6 million people died of cardiovascular disease (CVD) worldwide, and proportionally, this accounts for 31.43% of global mortality. Moreover, The emergence of valve-in-valve procedures serves as a significant market opportunity for the prosthetic heart valve.
Physicians are opting to use bioprosthetic valves because they are confident that in the case of tissue valve degeneration, they will be able to re-intervene and percutaneously implant a transcatheter valve. Given the high treatment costs associated with Transcatheter Aortic Heart Valve (TAVR), strict regulations by the government may restraint the market growth during the forecast period. However, if the cost of this technology can be reduced, as is expected with the approval of next-generation devices by manufacturers, the prosthetic heart valve will be the most lucrative market for medical device companies. For instance, in February, 2018, Medtronic Plc’s product- Mosaic bioprosthetic heart valve demonstrated positive performance and Long-Term Durability Up to 12 Years in International Study. This clinical study supports the long-term, robust performance of the Mosaic valve, and reinforces the trend in the decreasing average age of recipients.
Competition in the prosthetic heart valves market is intense and in order to maintain their competitiveness, companies are adopting strategies such as inorganic growth, merger and acquisition and product innovation. Product innovation continues to drive pricing, which acts as a huge barrier for new entrants in the market. Market players are also investing in expanding their product portfolios, resulting in their growing pipelines in the prosthetic heart valves market. For instance, in March 2017, Boston Scientific Corporation acquired Symetis SA, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation (TAVI) devices. The Symetis portfolio includes the Acurate TA and Acurate neo/TF valve systems for use in the treatment of high-risk patients suffering from severe and symptomatic aortic valve stenosis, which are sold in Europe and in other geographies outside of the United States. Symetis is also developing the ACURATE neo/AS next generation valve system, currently in a clinical trial intended to serve as the basis for a future CE mark application.
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