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.
To support the labeling change, Edwards 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 and the Society of Thoracic Surgeons.
“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.”
Analysts estimate as many as 70,000 to 100,000 patients per year could eventually receive the Sapien replacement valve.
Edwards Lifesciences Corp. reported $182 million in sales of the heart valve in the last quarter, or 35 percent of the company's total sales.