An FDA report released Monday showed that Edwards Lifesciences' Sapien heart valve, which can be implanted without major surgery, significantly reduced rates of death versus standard therapy in people with severe aortic stenosis. However, there was a higher incidence of major strokes and major vascular events seen in the group receiving the Sapien valve.
In its report, the FDA said "preclinical and clinical studies submitted in the PMA application provide reasonable assurance that the Model 9000TFX...are safe and effective for the replacement of native aortic valves when used according to the approved labeling." The Edwards Sapien transcather heart valve would be used in patients who are ineligible for open aortic valve replacement.
In a study, 358 patients with aortic stenosis were randomly assigned to standard therapy or Sapien implantation through the transfemoral approach. At one year, the rate of death from any cause among the intent to treat patients was 30.7% with the Edwards valve versus 50.7% with standard therapy, according to the FDA's report.
An FDA panel of experts will review the data on Wednesday to recommend whether the device's benefits outweigh its risks. As Reuters notes, if the valve eventually gets the regulatory sign off, it would be the first transcatheter aortic valve sold in the U.S. Commercial distribution of the SAPIEN Transcatheter heart valve Model 9000TFX and accessories outside the U.S. began in October 2007. Currently, the device is distributed in the EU, Russia, Israel, Singapore and a number of other countries.
On Thursday, the panel will make recommendations and vote on information related to the humanitarian device exemption for the Berlin Heart EXCOR pediatric ventricular assist device. The device is designed to provide bridge-to-transplant mechanical support to the heart.