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According to a new series of reports on the U.S. market for cardiac surgery and heart valve devices by iData Research, there is an emerging trend towards the use of minimally invasive procedures to treat heart conditions. The aging population is driving the market since the elderly in need of treatment are often not suitable for open heart surgery. As a result, procedures such as transcatheter heart valve replacement (THVR) are gaining prominence. These devices are replacing the heart valves used in open heart surgery as the standard way of replacing heart valves.

If given the choice, many patients would prefer the less invasive transcatheter aortic valve replacement (TAVR) procedure to open heart surgery. Rapid growth in unit sales of transcatheter aortic valve implantation (TAVI) devices is expected as patients elect to undergo TAVR procedures rather than surgical aortic valve replacement procedures. If the FDA approves TAVR devices for treatment of lower-risk patients, further unit sales growth is expected.

“Cardiac surgery is a rapidly growing market with new technological innovations occurring constantly,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “Over the next several years, new percutaneous aortic and mitral valve replacement devices are expected to be introduced into the U.S. market.”

Competition between manufacturers will cause a slight decline in average selling price (ASP). However, large expenditures in research and development from major players in the market will limit the ASP decline as more advanced technology will command price premiums. Therefore, the large increase in unit sales will apply upward pressure on market value. These new products, their delivery systems and the surgical techniques used for placing them will allow for a greater number of patients to be treated successfully. The increased procedural volume combined with the high ASP of percutaneous products is expected to propel growth in market value.

Edwards Lifesciences is the leading competitor in the U.S. TAVR market. Edwards Lifesciences was the first company to develop a percutaneous aortic valve replacement device. Their SAPIEN 3® is a TAVR device used for aortic valve replacement while the SAPIEN XT® is used for both aortic and pulmonary valve replacement. Edwards Lifesciences also offers a wide range of delivery systems alongside their heart valves.

Medtronic is the second leading competitor in the TAVR market. The company offers the CoreValve Evolut R® and PRO® Transcatheter Aortic Valve Replacement products. For pulmonary valve replacement, Medtronic has their Melody® Transcatheter Pulmonary Valve Therapy which has been approved by the FDA in 2017.

For Further Information
More on the transcatheter heart valve replacement market in the U.S. can be found in a series of reports published by iData Research entitled the U.S. Market Report Suite for Cardiac Surgery and Heart Valve Devices 2018. The full report suite on the U.S. market for cardiac surgery and heart valve devices includes tissue heart valves, mechanical heart valves, annuloplasty repair devices, transcatheter mitral valve repair devices, transcatheter aortic valve replacement devices, devices used to perform on and off-pump coronary artery bypass procedures, endoscopic vessel harvesting devices, anastomosis assist devices, transmyocardial revascularization devices, ventricular assist devices, inter-aortic balloon pumps, artificial heart devices, remote hemodynamic monitoring devices, patent foramen ovale closure devices, atrial septal defect closure devices, ventricular septal defect closure devices, left atrial appendage closure devices and extracorporeal membrane oxygenation machines and disposables.

The iData report series on cardiac surgery devices covers the U.S. and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxembourg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about cardiac surgery market and procedure data, register online or email us at [email protected] for a U.S. Market Report Suite for Cardiac Surgery and Heart Valve Devices 2018 brochure and synopsis.