FDA Approves Revised Labeling to Allow Alternative Access Sites for Edwards Sapien TAVR Device
September 23, 2013—The US Food and Drug Administration (FDA) announced that the agency has approved revised labeling for the Sapien transcatheter heart valve (THV) from Edwards Lifesciences Corporation (Irvine, CA).
The FDA noted that the Sapien device was previously approved for a transfemoral and a transapical approach in patients who have inoperable aortic valve stenosis. The new labeling removes references to specific access points now making it available for inoperable patients who need an alternate access point.
Edwards Lifesciences commented on the approval of the revised labeling in a statement to Cardiac Interventions Today, stating, “Edwards is pleased with the FDA’s approval to revise the labeling for the Sapien valve, which will enable expanded access for inoperable and high-risk patients with severe symptomatic aortic stenosis without restricting alternative access approaches.”
According to the FDA, to support the labeling change, Edwards Lifesciences submitted data from the Transcatheter Valve Therapy Registry (TVTR) in the United States and THV device registries in Europe, along with data from FDA-approved clinical studies and peer-reviewed medical journals. The TVTR data came from several thousand procedures performed on patients using an alternative access point and showed no evidence that the device performs differently or has a different benefit-risk profile based on the access point. The manufacturer will continue to use data from the TVTR to study short- and long-term patient outcomes of THV procedures using alternative access sites.
The TVTR, launched in 2012, collects clinical data on all transcatheter aortic valve replacements performed in the United States in order to study the short- and long-term outcomes of the procedure. The data are also an important source of clinical safety and effectiveness information once THVs are on the market. The TVTR is managed by the American College of Cardiology and the Society of Thoracic Surgeons.
Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health, commented on the approval in the agency’s press release. Dr. Shuren stated, “Just 2 years after the THV entered the market for a specific patient population, data from the TVTR were used to support FDA approval that expands patient access to a life-saving therapy. Medical device registries like the TVTR not only play an important role in the FDA’s postmarket surveillance system, [but] they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy.“
Dr. Shuren added, “Leveraging clinical research inside the framework of a device registry to expand access to therapy for more patients is a new paradigm for the FDA, researchers, registry sponsors, and the medical device industry. We believe this approach can be used with future well-designed device registries to speed patient access to important, well-evaluated therapies.”