Edwards Lifesciences Sapien

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According to a new report series on the U.S. cardiac surgery market by iData Research, transcatheter aortic valve implantation (TAVI) procedures are expected to increase in volume due to a large population of patients who would be able to benefit from TAVI, improved diagnostic capabilities, advancements in transcatheter aortic valve technology and the expanding indication for use of TAVI devices. These devices are only designated for use in patients that are unable to undergo or have a high-risk for complications during open heart surgery.

Aortic stenosis is by far the most common type of aortic valve problem, with more than 1.2 million Americans, mostly over 65 years old, having calcified aortic valves. The most common method for treating heart valve conditions is through the use of open surgery to replace a valve. However, some patients with heart valve problems are poor candidates for valve replacement surgery due to advanced age or pre-existing conditions. These high-risk patients are good candidates for transcatheter aortic valve implantation.

In addition, it is estimated that 50% of patients suffering from severe symptomatic mitral regurgitation (MR) are not referred for surgery and go untreated. These patients are not treated because surgeons deem the surgery unsafe, generally because the patients are either only showing early symptoms, their condition is too advanced for surgery, or they do not possess the strength to withstand and heal from an open heart surgery. But advances in diagnostic technologies, such as computed tomography and magnetic resonance imaging, are facilitating the earlier diagnosis of heart valve defects. While in the past, many patients with heart valve problems may not have been diagnosed until after showing serious symptoms, some valve defects are now being detected during routine checks.

This currently untreated demographic is the initial target market for transcatheter mitral valve implantation (TMVI) devices. As of July 2015, a price for TMVI devices had not been announced publicly. However, it is expected that TMVI devices will be priced slightly higher than TAVI devices, which are in the $30,000 range.

“If given the choice, many patients would prefer the less invasive TAVI procedure to open heart surgery”, explains Dr. Kamran Zamanian, CEO of iData. “Large growth in unit sales of TAVI devices is thus expected as patients elect to undergo transcatheter aortic valve replacement procedures rather than surgical aortic valve replacement procedures.”

Further growth in unit sales of TAVI devices is expected if the FDA approves TAVI devices for treatment of intermediate and moderate-risk patients. Large expenditures in research and development from major players in the market will limit the decline in average selling price (ASP), as more advanced technology will be able to command price premiums. The large increase in unit sales will therefore fuel market value growth.

Edwards Lifesciences, as the first company to develop a percutaneous aortic valve replacement device, has become the leading competitor in the market for heart valve defect treatments. The company offers a wide range of products used in aortic valve replacement procedures. Edwards’ presence in this sector combined with its relationships with the small number of specialized surgeons who perform these procedures will greatly assist in the adoption of this product as the market develops. However, other competitors such as Medtronic are gaining market share from Edwards Lifesciences. Medtronic acquired CoreValve, Inc. in 2009 to obtain the rights to the CoreValve® System, which has obtained approval from the FDA. The CoreValve Evolut R® is approved for use in patients who are unable to undergo, or at high-risk, for open heart surgery.

For Further Information
More on the cardiac surgery market in the US can be found in a series of reports published by iData comprising the US Market for Cardiac Surgery and Heart Valve Devices. The market segments covered in these reports include tissue heart valves, mechanical heart valves, annuloplasty repair devices, transcatheter heart valve repair devices, transcatheter heart valve implantations, on-pump coronary artery bypass devices, off-pump coronary artery bypass devices, endoscopic vessel harvesting market, anastomosis assist devices, transmyocardial revascularization devices, ventricular assist devices, intra-aortic balloon pump devices, artificial heart replacement devices, patent foramen ovale devices, atrial & ventricular septal defect devices, and left atrial appendage closure devices.

The iData series on cardiac surgery covers the U.S., China, Japan, South Korea, Australia, and 15 countries in Europe encompassing Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands and Luxemburg), Scandinavia (Finland, Denmark, Sweden and Norway), Portugal, Austria and Switzerland. Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment.

Register online or email us at [email protected] for a 2016 U.S. Markets for Cardiac Surgery and Heart Valve Devices report brochure and synopsis and let us know if you will be attending the 2015 Transcatheter Cardiovascular Therapeutics TCT Conference in San Francisco, California from October 12-14. We will be at our booth #2429 in the Publications area on the show floor located near the TCT Lounge and the Conference Suites. Come visit us and participate in our 2015 TCT Physician Survey and receive a free gift.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by State, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

About Reimbursement Tracker
iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.


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