BETHESDA, MD — The US Food and Drug Administration has approved new labeling for the Sapien transcatheter valve (Edwards Lifesciences) that excludes references to the specific access sites used by operators implanting the valves. The change effectively makes it possible for interventionalists and surgeons to use whatever approach is best suited to the patient's anatomy—the previously approved transfemoral and transaortic approaches, as well as the subclavian approach not mentioned in previous labeling.
The expanded labeling information is supported by data from the Transcatheter Valve Therapy Registry (TVTR) in the US, plus other registries in Europe.
"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," an FDA announcement reads. "The manufacturer will continue to use data from the TVTR to study short- and long-term patient outcomes of [transcatheter heart valve] procedures using alternative access sites."
Reacting to the announcement, president of the American College of Cardiology Dr John G Harold says the FDA's decision collected some credit on behalf of the ACC and Society for Thoracic Surgeons, who partnered on the Transcatheter Valve Therapy Registry. "The FDA's decision is a true testament to the efficiency of rigorous clinical registries, which allowed the FDA to make a prompt decision that will impact thousands of patients who previously would have not had access to this procedure."
Cite this: Expanded FDA Indication for Sapien Valve - Medscape - Sep 24, 2013.