Aortic valve is a valve in the human heart between the left ventricle and the aorta. In case the aortic valve gets damaged, it is replaced or removed with an artificial aortic valve. The aortic valve replacement is done through open surgical procedures or minimally invasive surgical procedures. The aortic valve market is witnessing tremendous growth potentials, predicts the research carried out by P&S Market Research. According to the report, this growth is attributable to the increasing prevalence of valvular diseases, increasing demand for minimally invasive surgeries (MISs), rise in number of clinical trials for heart valves, and introduction of advanced implants.
Favorable insurance policies and reimbursement scenario is one of the crucial factors, which is anticipated to drive the aortic valve market in the following years. The growing number of approvals and increasing number of sponsors in this market are some of the factors, which are also contributing to improved coverage. For instance, the Centers for Medicare & Medicaid Services (CMS) announced that it had issued coverage of TAVR under the Medicare National Coverage Determination policy. The reimbursement rates for various procedures varies according to the insurance company. Heart valve replacement falls under major illness category. The amount of the reimbursement is dependent on the sum insured.
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The regulatory requirements for medical devices are vast and rapidly evolving. These regulations are mostly complicated due to legal technicalities. The safety, consistent quality and performance of medical devices are necessary facets that need stringent evaluation for international public health. Therefore, it leads to complex and stringent regulations and standards for medical devices affiliation. According to the Institute of Medicine of the National Academies’ report to Congress 2011, the medical device approval process is too stringent and time-consuming, which delays new medical devices entering the market. It also leads to increase in the cost of research and development. It has been observed that medical device regulations and requirements vary by country, specific product claims, intended use of the device and the level of risk involved.
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Edwards Lifesciences Corporation and Medtronic plc are the leading players in the transcatheter aortic valve market. As of 2017, Edwards Lifesciences Corporation and Medtronic plc accounted for 59.0% and 25.2% share, respectively, in the global market.