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.

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.

Structural Heart Devices Market Regional Analysis

North America is expected to hold a dominant position in global structural heart devices market, owing to continued research for the development of novel product and subsequent launches by major key players present in the region. For Instance, in 2017, Edwards Lifesciences Corporation, an U.S-based company is focusing on Launch of SAPIEN 3 Ultra and CENTERA Valves. SAPIEN 3 Ultra system is a next-generation platform with expandable Axela sheath technology and on-balloon delivery design. This novel product is expected to accelerate the make procedures with less chances of mistakes. Furthermore, Europe is expected to witness significant growth in structural heart devices market, owing to 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.

Structural Heart Devices Market Restraint

Advanced products such as sutureless heart valve costs significantly higher than earlier available product. For instance, the price of suture less heart valve, aortic manufactured by LivaNova, Plc. is more than US$ 9,000 whereas tissue heart valves manufactured by Medtronic Plc., and Abbott Laboratories costs around US$ 5,000 in the U.S. This almost double price of sutureless device has limited its adoption, which in turn is restraining growth of the market.

Structural Heart Devices Market Key Players

Key players in global structural heart devices market include 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. Key players in the market are focused on strategic merger and acquisition in order to expand its structural heart device product portfolio. For instance, in 2017, Edwards Lifesciences Corporation, an U.S. based medical device manufacturer, acquired Harpoon Medical, Inc. in US$ 100 cash and additional US$150 million in milestone payments over 10 years. With this strategic acquisition Edwards Lifesciences Corporation has widen its offerings with mitral valve repair technology, which is designed to reduce the amount of time required for mitral valve surgery.

Structural Heart Devices Market Taxonomy

The global structural heart devices market is segmented on the basis of product type, indication, end user, and region.

Product Type
- Heart Valve
  - Transcatheter Heart Valve
  - Mechanical Heart Valve
  - Surgical Heart Valve
- Annuloplasty rings
- Occlusion Devices
Indication
- Valvular Heart Disease
  - Regurgitation
  - Stenosis
- Cardiomyopathy
- Congenital Heart Defects
- Others
End User
- Hospitals
- Ambulatory Surgical Centers
Region
- North America
- Latin America
- Europe
- Asia Pacific
- Middle East
- Africa

About Author

Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.