The US Food and Drug Administration today approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis, a disease of the heart valves that causes narrowing of the aortic valve, restricting blood flow from the heart.
People with severe aortic valve stenosis must have a heart valve replacement to restore normal blood flow.
Those who are in good enough health to tolerate surgery usually undergo aortic valve replacement during open-heart surgery using a heart-lung machine to take over the function of the heart and lungs during the surgical procedure.
Because of the overall risks and extended recovery time associated with open-heart surgery, about 30 percent of patients are considered inoperable or at high risk for surgical complications and are not referred for this surgery.
The Sapien THV is implanted without opening the chest or heart and does not require a heart-lung machine. The device is compressed into a thin, flexible delivery catheter, inserted into an access point in the body and threaded to the site of the diseased valve.
The FDA previously approved the valve for insertion through the femoral artery (transfemoral approach), through the leg or through the lower tip of the heart (transapical approach). The new labeling removes references to specific access points now making it available for inoperable patients who need an alternate access point.
To support the labeling change, Edwards Lifesciences Corp. 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 is 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 (ACC) and the Society of Thoracic Surgeons (STS).
“Just two 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 life-saving therapy,” said Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health.
“Medical device registries like the TVTR, not only play an important role in the FDA’s post market surveillance system, they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy. “
“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,” said Shuren.
“We believe this approach can be used with future well-designed device registries to speed patient access to important, well-evaluated therapies.”
The Sapien Transcatheter Heart Valve (THV) is made by Edwards Lifesciences Corp., headquartered in Irvine, Calif.