FDA OKs Recapturable TAVR System from Medtronic

Competition in the U.S. transcatheter aortic valve replacement (TAVR) market continues to heat up.

The U.S. Food and Drug Administration (FDA) has approved the new recapturable, self-expanding CoreValve Evolut R System from Medtronic plc. The company claims the implant is “the first-and-only recapturable and repositionable device available” in the United States for TAVR in severe aortic stenosis patients who are at high or extreme risk for surgery.

The same technology received CE mark in Europe in February.

Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death.

Designed to treat patients with aortic stenosis, a condition where the aortic valve narrows thereby limiting blood flow from the aorta to the rest of the body.

“In a short time, the TAVR procedure has become an established treatment option for high-risk patients with severe aortic stenosis who are unable undergo surgery, and physicians are looking to technology advancements to help deliver even better patient outcomes,” said Mathew Williams, M.D., co-primary investigator for the clinical study that evaluated the technology, as well as chief of adult cardiac surgery and director of Interventional Cardiology and Structural Heart at the NYU Langone Medical Center in New York, N.Y. “Clinical data have shown the best patient outcomes are achieved when the valve is properly positioned. The advancement of recapturability with Evolut R gives physicians more confidence during the procedure and provides advantages that are non-existent in other TAVR systems.”

The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R Delivery System, which features a sheath that reduces the profile to the lowest on the market (14 Fr equivalent, less than a fifth of an inch). A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5 millimeters), through the preferred transfemoral access route, which may minimize the risk of major vascular complications in some patients, according to the company.

Based on the knowledge gained through the extensive experience with the CoreValve System, the Evolut R is optimized to increase conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance. An extended sealing skirt on the 26 millimeter and 29 millimeter valve sizes is intended to further promote valve sealing at the annulus, said officials with Dublin, Ireland-based Medtronic.

“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 March, the CoreValve System was the first TAVR system to be approved in the United States for valve-in-valve procedures in patients whose surgical aortic heart valves have failed. Also in March, the highly anticipated two-year data from the high-risk study of the CoreValve U.S. pivotal trial was presented at American College of Cardiology annual meeting, which showed superior survival benefit at two years for TAVR with the CoreValve System compared to patients who underwent surgical aortic valve replacement.

Recently, market research firm GlobalData reported that the compound annual growth rate (CAGR) for TAVR valves will increase 19.7 percent between 2013 and 2020, expanding from $881 million to more than $3 billion over the period. The projection is based on sales in the United States, Germany, France, Italy, Spain, the United Kingdom, Japan, Brazil, China and India. The United States and Germany, to date, are considered the leading growth opportunities, analysts noted.

Demand for surgical valves will continue to increase as well, but as a much slower rate. The CAGR for surgical valves was placed at 3.2 percent, with the market reaching $1.08 billion by 2020. In the U.S., TAVR valves can cost 10 times or more than surgical valves.

Analysts cited regulatory approval of TAVR devices as drivers of growth. The FDA has allowed marketing of Sapien valves from Edwards Lifesciences and CoreValve systems from Medtronic in the U.S. Newer generation devices from these companies—such as the technolgoy mentioned above—as well offerings from other companies such as Boston Scientific’s Lotus valve system will impact the market as well.