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The labeling for the Sapien transcatheter heart valve no longer includes references to specific access points, which will expand the group of patients who can be treated with the device, the Food and Drug Administration announced.
Approval has been for use via a transfemoral or transapical approach. But revised labeling for the device has been approved, which removes references to specific access points, according to the FDA statement issued on Sept. 23. Spokespersons for the FDA and for Edwards Lifesciences, the manufacturer of the valve, confirmed that the references to specific access points have been dropped for both inoperable and high-risk patients.
The approval for this change was based on data from patient registries in the United States and Europe and other sources, according to the announcement.
The percutaneous valve was approved in 2011 for treating patients with severe aortic stenosis who are considered inoperable, making it the first artificial heart valve that could be used to replace a damaged valve without open heart surgery. That approval was expanded in October 2012 to include patients who are operable but at high risk.
Edwards submitted data to the FDA for the labeling change from the Transcatheter Valve Therapy Registry (TVTR) in the United States, transcatheter heart valve (THV) device registries in Europe, as well as FDA-approved clinical studies and peer-reviewed medical journals. Data from the TVTR, which is managed by the American College of Cardiology (ACC) and the Society of Thoracic Surgeons, 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 statement said.
"Just 2 years after the THV entered the market for a specific patient population, data from the TVTR was used to support FDA approval that expands patient access to a lifesaving therapy," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the statement. "Medical device registries like the TVTR not only play an important role in the FDA’s postmarket surveillance system, they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy," he 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," Dr. Shuren noted.
Since 2012, the TVTR has collected data on all transcatheter aortic valve replacements performed in the United States. The manufacturer will use these data to evaluate short- and long-term outcomes in patients who receive the Sapien valve through an alternative access site, the FDA statement said.
ACC President John G. Harold, M.D., said in a statement that "the FDA’s decision is a true testament to the efficiency of rigorous clinical registries, which allowed FDA to make a prompt decision that will impact thousands of patients who previously would have not had access to this procedure."
