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The FDA has approved the Evolut R by Medtronic, a new recapturable, self-expanding system for transcatheter aortic valve replacement (TAVR). The first of its kind in the US, this new device is for the treatment of patients with severe aortic stenosis who are at high or extreme risk for surgery. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.

“The FDA approval of Evolut R marks a significant milestone for Medtronic and TAVR, and ushers in a new era in transcatheter aortic valves with advanced, recapturable capabilities,” said Rhonda Robb, vice president and general manager, Heart Valve Therapies, Medtronic. “This approval is an outcome of our commitment to building a market-leading innovation pipeline in the transcatheter space, and we look forward to supporting heart teams as they look to next-generation technologies that optimize valve performance for a broad range of patients.”

“In a short time, the TAVR procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable to undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” Mathew Williams, MD, chief of adult cardiac surgery and director of interventional cardiology and structural heart at NYU Langone Medical Center, said in the release. “The advancement of recapturability with Evolut R gives physicians more confidence during the procedure.”

About Medtronic
Medtronic (, headquartered in Dublin, Ireland, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.

For Further Information
More on the interventional cardiology market in the U.S. can be found in the report published by iData entitled U.S. Market for Interventional Cardiology Devices. This report also covers the U.S. market segments for bare-metal and drug-eluting stents, PTCA and cutting balloons, balloon-inflation devices, interventional coronary catheters, interventional coronary guidewires, coronary embolic protection devices, coronary atherectomy devices, coronary thrombectomy devices, coronary chronic total occlusion crossers, introducer sheaths, coronary vascular closure devices, diagnostic coronary catheter and guidewires, intravascular ultrasound catheters, and optical coherence tomography catheters.

The iData series on the market for interventional cardiology devices covers the U.S., Japan, Brazil, and 15 countries in Europe. 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.

To find out more about U.S interventional cardiology market data or procedure data, register online or email us at [email protected] for a U.S. Market for Interventional Cardiology Devices report brochure and synopsis.

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

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