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Balloon-expandable TAVR system receives FDA indication for use in intermediate-risk patients
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Edwards Lifesciences Corporation and the FDA announced that the agency has granted an indication for use of its balloon-expandable transcatheter aortic valve replacement system in patients with severe symptomatic aortic stenosis at intermediate risk for open-heart surgery.
The valves (Sapien 3 and Sapien XT) are the first TAVR therapies to be approved for the intermediate-risk population in the United States, the company and the FDA stated in press releases.
“The clinical outcomes of 1.1% mortality and 1% disabling stroke at 30 days in this intermediate-risk population treated with the Sapien 3 valve are changing the paradigm of how we treat patients with aortic stenosis,” Vinod Thourani, MD, co-director of Emory Heart and Vascular Center’s Structural Heart and Valve Center and professor of cardiothoracic surgery at Emory University School of Medicine, Atlanta, said in the company release.
Vinod Thourani
Approval was based on data from the PARTNER II trial, which involved 2,005 intermediate-risk patients at 51 sites in the U.S. and Canada. The study showed that patients treated with the transcatheter valve experienced clinically significant improvements for the composite primary endpoint of mortality, stroke and moderate or severe aortic regurgitation at 1 year compared with those undergoing surgery.
Patients with a mortality risk score of 3% at 30 days based on the Society of Thoracic Surgeons Predicted Risk of Mortality calculator and other clinical comorbidities as determined by a Heart Team are eligible for the treatment with the valve, the company stated.
According to the FDA release, a condition of the approval is that Edwards must conduct a post-approval study to follow intermediate-risk patients treated in PARTNER II with Sapien 3 or Sapien XT for 10 years to accumulate additional safety and efficacy data.
"This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement," Bram Zuckerman, MD, director of the division of cardiovascular devices at FDA's Center for Devices and Radiological Health, said in the agency release.
According to the FDA, the device is contraindicated for patients who cannot tolerate blood-thinning medication or are being treated for an infection, and complications from the procedure can include death, stroke, acute kidney injury, MI, bleeding and permanent pacemaker implantation.
Disclosure: Thourani reports serving on the steering committee for the PARTNER trial and consulting for Direct Flow Medical, Edwards Lifesciences, Sorin and St. Jude Medical. Zuckerman is an employee of the FDA.
Editor's Note: This article was updated on Aug. 19, 2016 to add information from the FDA press release, including the Sapien XT device being covered by the approval.