According to an announcement in Cardiovascular Business, Edwards LifeSciences is scheduled to receive a review of the PMA submission for its transcatheter aortic valve, SAPIEN, on July 20. Pending approval, the SAPIEN will be the first commercially available transcatheter aortic valve in the United States. Designed to provide a minimally invasive alternative to traditional surgical aortic valve replacement, the SAPIEN offers a new therapy to treat severe aortic stenosis in inoperable or high-risk patients. Given the device's great success in Europe, Canada, and Australia, interventional cardiologists and cardiac surgeons in the U.S. are eagerly anticipating its release.
Edwards submitted its PMA application for approval in fall of 2010 following positive results in the Cohort B arm of the pivotal PARTNER trial. Findings demonstrated a significant improvement in mortality for inoperable patients who received the therapy versus those who were managed medically. Moreover, in April of 2011, results of the Cohort A arm, which randomized high-risk patients to SAPIEN versus surgical replacement, were released and showed non-inferiority in mortality.
Technology Insights will continue to monitor the FDA panel and updates in the transcatheter valve space.