One Step Closer To FDA Approval For SAPIEN Aortic Valve?

Within our patient and caregiver community, there is great excitement about transcatheter aortic valve replacement technology. These non-invasive approaches for aortic stenosis treatment are often described with adjectives including revolutionary and transformational.


Edwards SAPIEN Heart Valve Replacement

I wanted to relay new information about the FDA approval process for one of these percutaneous devices, the SAPIEN aortic valve replacement by Edwards Lifesciences. This valve, which does not require an incision to the sternum or ribs for implant, received two favorable votes from an advisory panel of cardiologists which reviewed its most recent clinical trial:

  • The panel voted 9 to 0 that the SAPIEN’s benefits outweigh its risks (one member of the panel abstained).
  • The panel voted 7 to 3 that the SAPIEN is safe for its intended patient category, which is comprised of high-risk patients that are too frail for traditional surgical approaches.

This is a significant step for the SAPIEN as there continues to be concern about the increased rate of stroke and patient complications for SAPIEN trial recipients, according to Medical News Today.

Dr. Augusto Pichard, a principal investigator for the SAPIEN trial at the Washington Hospital Center, said that although vascular complications declined during the trial, the causes of a 7.3% stroke rate in the first month and 10.6% rate in the first twelve months were unclear. However, looking forward, Dr. Pichard called the potential approval a “saving grace” for inoperable patients with severe aortic stenosis. (To learn more about stenosis, click here.)

While this minimally invasive device — which is delivered through the femoral artery or the left ventricle — has yet to receive FDA approval in the United States, the SAPIEN is commercially available in Europe. (On Sunday, my dad told me that one of his friends just traveled to Germany to have the SAPIEN implanted.)

Medical Image Of TAVI Positioned Via Transfemoral
SAPIEN Heart Valve Replacement Implant Procedure

Interestingly, the FDA does not need to accept the view of its advisory panels. Several reports, however, suggest this is a common practice. As of yet, no date has been provided as to when the official FDA evaluation will come for the SAPIEN device.

Needless to say, I will continue to monitor the SAPIEN and other technologies that could greatly impact valvular treatment in the future.

Keep on tickin!

Adam Pick
Written by Adam Pick

Adam Pick is a patient, author of The Patient's Guide To Heart Valve Surgery and the founder of HeartValveSurgery.com.

To learn how Adam has helped millions of people with heart valve disease, watch Adam's video, subscribe to his free newsletter, or visit his Facebook, or Twitter pages.

  • Jim Hayden

    I have a prosthetic aortic valve. Can the Sapien be installed in the prosthetic if it has stenosis?

  • robin fairchild

    I will very soon have a tissue aortic valve replacement. So this question is very pointed for me since my new valve may fail in a decade, (or more, or less), and it would be nice to know I would not have to be surgically invaded again.

  • GAIL DAVIS

    IS THE SAPIEN VALVE OPERATION PERFORMED IN STOKE,STAFFORDSHIRE,ENGLAND,UK
    MY FATHER IS ABOUT TO UNDERGO VALVE REPLACEMENT AND HE HAS ONLY BEEN OFFERED THE OPEN HEART METHOD OF SURGERY
    HE IS 80YRS OLD

  • 5AshliPoplin

    I love it! Excellent article. Cool to read such a well-considered article! By the way, if anyone is facing a problem of filling a form, I’ve found a template here http://goo.gl/klcSyp. You also can esign the form and fax it.

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