FDA OKs new Sapien 3 valve from Edwards

The FDA said today that it approved Edwards Lifesciences‘s (NYSE:EW) Sapien 3 transcatheter heart valve for inoperable or high-risk patients with a narrowing in the heart’s aortic valve.

The approval was based on a 583-patient clinical study of patients who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk, the federal watchdog said.

“Clinical data showed that the Sapien 3 transcatheter heart valve is superior to the 1st generation Sapien transcatheter heart valve, with significantly less leakage through and around the valve,” FDA director of the center for devices and radiological health Dr. William Maisel said in an FDA news release.

The FDA said that Sapien 3 patients could also face risks of serious complications from implantation, including “death, stroke, acute kidney injury, heart attack, bleeding and the need for a permanent pacemaker.” The federal watchdog also said that the device was not indicated for patients who could not tolerate anticoagulation or antiplatelet therapy.

Earlier this year, Edwards CEO Michael Mussallem said the company was hopeful the FDA would approve the Sapien 3 this year. CFO Scott Ullem said a 4th-quarter approval for the Sapien 3 valve would add only about $10 million in sales in the 1st few months.

The Sapien 3 valve, designed in part to address some of the concerns about leakage in earlier generations of valves, has been on the European market since approval in January 2014. The Sapein 3 is Edwards 3rd generation Sapien heart valve, originally approved by the FDA in 2011.

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