Edwards Lifesciences is reporting that the first three human implants of the next-generation Edwards transcatheter aortic heart valve, dubbed Edwards Sapien THV, were performed by John Webb, M.D., director of the cath lab and cardiac intervention at St. Paul’s Hospital in Vancouver, BC. This percutaneous valve, conceived for the treatment of severe aortic stenosis, could be delivered via transfemoral approach (with the RetroFlex delivery system) or via transapical placement (with the Ascendra delivery system). The picture below illustrates the transapical approach.
Edwards’ next-generation balloon-expandable pericardial tissue valve features a cobalt chromium alloy frame that reduces the profile by four to five French. This enables easier access into and within the patient’s vasculature for delivery of the valve without open-heart surgery. The new valve will also be offered in additional sizes and builds upon Edwards’ more than 20 years of clinical experience and innovation with the most advanced tissue engineering technologies.
"This is a very exciting milestone in the progression of minimally-invasive valve therapy. The refinements to the new Edwards valve provide the opportunity to make the transcatheter technology available to an even broader group of patients suffering from severe aortic stenosis," said Webb, who along with his multidisciplinary team has performed more than 150 transcatheter aortic valve replacement procedures. "Providing patients and clinicians with a comprehensive selection of treatment options, including this new valve, can increase the likelihood that these very ill patients will seek and find appropriate treatment."
Edwards is the only company currently engaged in a U.S. clinical trial of a transcatheter aortic heart valve. The Edwards SAPIEN valve with both the RetroFlex transfemoral and Ascendra transapical delivery systems is being evaluated in the PARTNER (Placement of AoRTic traNscathetER valves) pivotal trial for U.S. Food and Drug Administration (FDA) approval.
"We estimate that for every patient who receives an aortic valve replacement, there is another who goes untreated; half of these untreated patients with severe symptoms will die within two years," said Craig Smith, M.D., chief of the division of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center and the co-principal investigator for the U.S. PARTNER trial. "Soon physicians will be able to treat virtually all high-risk aortic stenosis patients with transcatheter valves, delivered transapically or transfemorally, as we continue to carefully study the long-term performance of this technology."