Edwards' Competitive Edge in TAVR Gets Even Sharper

Posted in Cardiovascular by Nancy Crotti on June 7, 2017

Editor's Note: This story has been updated to clarify that Medtronic was first to recieve FDA approval for aortic valve-in-valve replacement procedures in 2015, while Edwards is now first to recieve the valve-in-valve indication for mitral valve replacement procedures.

 

The valve-in-valve replacement indication for Sapien 3 is a U.S. first for mitral vales, but Medtronic's CoreValve and Evolut R systems received FDA approval for aortic valve-in-valve replacements in 2015.

Nancy Crotti

FDA has given Edwards Lifesciences’ Sapien 3 transcatheter heart valve expanded approval to replace older bioprosthetic aortic or mitral valves in patients at high risk for death or severe complications from surgery. The mitral valve-in-valve indication is a first for FDA, and gives Edwards a further edge against rivals Boston Scientific and Medtronic. It is important to note, however, that Medtronic received FDA approval for aortic valve-in-valve procedures, which was the first time FDA approved any transcatheter heart valve for the valve-in-valve indication.

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Edwards Sapien 3 is now FDA approved for aortic, and mitral valve-in-valve replacement procedures in patients who are considered high risk for death or severe complications from open surgery.

Bioprosthetic transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR) implants are placed in a patient’s heart via a blood vessel or a small cut in the chest. Like the valves they replace, these prosthetic valves may also begin to fail over time due to age, patient anatomy, or stenosis, causing a patient’s heart to work harder or to leak blood backward, or both. Treatment for failing aortic valve devices would normally require repeat open-heart surgery. Patients who have failing mitral valve devices are not considered candidates for surgery.

"This new approval offers U.S. patients with failing surgical bioprosthetic aortic or mitral valves a less-invasive treatment option," said Bram Zuckerman, MD, director of the division of cardiovascular devices at FDA’s Center for Devices and Radiological Health in an agency statement.

“FDA approval of the Sapien 3 transcatheter heart valve for this new valve-in-valve indication represents a small but important option for those patients with no other options,” Larry Wood, Edwards' corporate vice president of transcatheter heart valves, told Qmed in an email. “For U.S. patients in need of another mitral valve replacement, this FDA approval gives them an option that previously did not exist.”

FDA originally approved the Sapien 3 for high-risk patients in 2015 and for intermediate-risk patients the following year. Before expanding its approval for valve-in-valve replacements, the agency evaluated data from the Transcatheter Valve Therapy Registry, a partnership of the American College of Cardiology and the Society of Thoracic Surgeons. The registry collects clinical data on the safety and effectiveness of TAVR procedures performed in a real-world setting.

The outcome data used to support Edwards’ latest Sapien 3 application consisted of 314 patients who had undergone aortic valve-in-valve procedures and 311 patients who had undergone mitral valve-in-valve procedures, FDA noted.

The registry data showed that more than 85% of patients who underwent aortic or mitral valve-in-valve procedures experienced clinically meaningful improvement in their heart failure symptoms 30 days after the procedure, as shown by their New York Heart Association (NYHA) classifications. The NYHA classification is a common heart failure symptom rating system. In both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery, the agency said.

Wood declined to comment on whether Edwards is seeking a similar approval from the EU. The company will continue to evaluate whether to ask for FDA approval for valve-in-valve TAVR and TMVR replacements in patients who have moderate risk from open heart surgery, he said.

Edwards continues to lead the way in the TAVR market. During the recent EuroPCR meeting, the company released several new study results, including data demonstrating excellent outcomes for TAVR patients treated with the Centera valve. These 30-day results were the first data presented on the company's new self-expanding valve.

Nancy Crotti is a contributor to Qmed.

 

[Image credit: Edwards Lifesciences Corp.]