STRUCTURAL HEART DEVICES MARKET ANALYSIS

Structural Heart Devices MarketSize and Trends

Structural Heart Devices Market Drivers

In 2017, Medtronic plc. received the U.S. Food and Drug Administration (FDA) approval for its new CoreValve Evolut PRO valve for the treatment of severe aortic stenosis in symptomatic patients who are at high or extreme risk for open heart surgery. Moreover, the company has launched CoreValve Evolut PRO valve in the U.S. market in the same year. In 2017, Medtronic plc. received CE Mark for its CoreValve Evolut R 34 mm valve and launched it in European market. CoreValve Evolut R 34 mm is the largest sized transcatheter aortic valve implantation (TAVI) system available in Europe. In 2015, Edwards Lifesciences Corporation, an U.S.-based company focused on heart valves and hemodynamic monitoring received U.S. Food and Drug Administration (FDA) approval for its Edwards SAPIEN 3 valve, a transcatheter aortic heart valve used for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. Furthermore, companies operating in the area are looking to expand product portfolio through inorganic growth. For instance, in 2015, CryoLife, Inc., an U.S.-based medical device company acquired the U.S. based On-X Life Technologies Holdings, Inc., a privately held mechanical heart valve company. CryoLife, Inc. entered in mechanical valve market with On-X Life Technologies Holdings, Inc.’s products with this strategic acquisition.

Market Trends increasing prevalence of Valvular Heart Disease (VHD) in the region. According to a study published in British Medical Journal (BMJ) in 2017, incidence of VHD was 63.9 per 100 000 person-years, with aortic stenosis (AS; 47.2%), mitral regurgitation (MR; 24.2%) and aortic regurgitation (AR; 18.0%). The study analyzed nationwide hospital data between 2003 and 2010 to reach to this conclusion.