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

TOBA-BTK study, twelve-month results, SCAI 2016, Tack Endovascular System, critical limb ischemia
News | Peripheral Arterial Disease (PAD)| May 05, 2016
Intact Vascular Inc. announced that positive twelve-month results from its Tack Optimized Balloon Angioplasty – Below-...
SCAI, cath lab, best practices, guidelines, 2016
News | Cath Lab| May 05, 2016
May 5, 2016 — The Society for Cardiovascular Angiography and Interventions (SCAI) published an update to its 2012 pap
aortic valve reconstruction, surgery, PinnacleHealth, Pennsylvania
News | Cardiovascular Surgery| May 04, 2016
Three PinnacleHealth patients recently underwent a new procedure for aortic valve reconstruction using the patients'...
FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Mitralign Percutaneous Annuloplasty System, MPAS, CE Mark approval
News | Annuloplasty Rings| April 27, 2016
Mitralign Inc. announced its Mitralign Percutaneous Annuloplasty System (MPAS) has received CE mark approval from its...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Overlay Init