Structural heart diseases refer to cardiac defects, which are congenital (by birth) in nature and also includes the abnormalities developed in valves and vessels of the heart caused by wear or tear due to some disease. Structural heart diseases is a non-coronary abnormality of heart, which does not affect the blood vessels in the heart. Common structural heart condition includes atrial septal defect, patent foramen oval, ventricular septal defect, paravalvular leak, arterial/venous fistulae, and congenital heart disease.

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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.

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Key Vendors:

Abbott Laboratories, Medtronic Plc., Edwards Lifesciences Corporation, Boston Scientific Corporation, CryoLife Inc., LivaNova Plc., Cook Group Incorporated, Endologix Inc., and W. L. Gore & Associates, Inc.

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