Feature | June 14, 2012

FDA Panel Recommends Expanding Sapien Transcatheter Valve for High-Risk Patients

Expanded indication would make TAVR more widely available

June 14, 2012 — A U.S. Food and Drug Administration (FDA) advisory panel voted in favor of recommending expanding the indication for the Edwards Lifesciences Sapien transcatheter heart valve for the treatment of high-risk patients. Currently, the Sapien is only indicated for patients who are too sick to undergo valve replacement surgery for severe, symptomatic aortic stenosis. The panel voted 11-0, with one abstention, that the benefits of the heart valve outweighed the risks for these patients.

If the FDA clears the additional indication, it will further expand the use of transcatheter aortic valve replacement (TAVR) therapy to more patients. Many experts predict TAVR will eventually replace the very invasive gold-standard therapy of open-heart aortic valve replacement surgery in the coming years.

Edwards submitted a premarket application (PMA) in April 2011 based on data from the high-risk cohort (Cohort A) of the PARTNER trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery, evenly randomized to receive either surgical aortic valve replacement or the Sapien valve via transfemoral or transapical delivery. In November 2011, the FDA approved the Sapien valve via transfemoral delivery for the treatment of inoperable patients with severe, symptomatic aortic stenosis.

"We are very encouraged by the advisory panel's strong recommendation for approval to expand the current indication for the Edwards Sapien valve to patients at high risk for surgery. A broader indication for high-risk patients would enable multi-disciplinary heart teams to choose the approach best suited to their patients' needs, including for the first time a transapical delivery option," said Michael A. Mussallem, Edwards' chairman and CEO. "We look forward to working closely with the FDA during the review process, and thank the panel for their thoughtful analysis of the PARTNER trial results."

The Sapien valve is currently an investigational device for the treatment of high-risk operable patients in the United States.

For more information: www.edwards.com

Related Content

Medtronic Announces TAVR Study of Aortic Stenosis Patients With Bicuspid Valves
News | Heart Valve Technology | September 19, 2018
The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) to initiate a new...
4C Medical's AltaValve First-in-Human Experience to be Presented at TCT 2018
News | Heart Valve Technology | September 17, 2018
September 17, 2018 — 4C Medical Technologies Inc.
Gore Acquires Pipeline Medical Technologies Inc.
News | Heart Valve Technology | September 06, 2018
W. L. Gore & Associates Inc. (Gore) announced the acquisition of Pipeline Medical Technologies Inc., a privately...
The Edwards Lifesciences Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May.

The Edwards Cardioband Tricuspid Valve Reconstruction System received the European CE mark approval in May, becoming the first transcatheter tricuspid repair device to be approved in the world.

Feature | Heart Valve Technology | August 21, 2018 | Jeff Zagoudis
The tricuspid valve has been dubbed “the forgotten valve” by many practitioners in the interventional cardiology spac
Earlier Intervention for Mitral Valve Disease May Lead to Improved Outcomes
News | Heart Valve Technology | July 26, 2018
The number of patients undergoing mitral valve operations are at an all-time high, and new research suggests many...
The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system  is being tested in the SUMMIT Trial.

The Abbott Tendyne transcatheter mitral valve replacement (TMVR) system.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — The pivotal clinical study in the U.S.
A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

A CoreValve TAVR valve seen in a CT scan looking down from the aortic arch into the left ventricle using reconstruction software from TeraRecon.

Feature | Heart Valve Technology | July 26, 2018
July 26, 2018 — A new multi-societal expert consensus document has been released that summarizes the position of thes
Abbott Receives FDA Approval for Third-Generation MitraClip Device
Technology | Heart Valve Technology | July 18, 2018
July 18, 2018 — Abbott announced it received approval from the U.S.
Videos | Heart Valve Technology | July 18, 2018
Jonathon Leipsic, M.D., FSCCT, professor of radiology and cardiology at the University of British Columbia, Vancouver
Videos | Heart Valve Technology | July 10, 2018
Ori Ben-Yehuda, M.D., executive director of the Cardiovascular Research Foundation Clinical Trial Center, discusses t
Overlay Init