UPDATED June 18, 2015, with details from Edwards and Leerink Partners.
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.
“The Sapien 3 valve sets a new standard for transcatheter heart valve performance and patient outcomes. We have seen some of the best results to date from the Partner II trial in treating high-risk patients with the Sapien 3 valve. The Partner II study concluded that this new valve reduced several complications associated with the TAVR procedure such as paravalvular leakage and stroke, and represented a meaningful improvement over data from prior studies with earlier-generation devices,” co-principal investigator Dr. Martin Leon director at the Columbia University Medical Center said in a press release.
“U.S. physicians have been eagerly awaiting the launch of the Edwards Sapien 3 valve since it became available in Europe last year, and we appreciate the FDA’s timely and thoughtful review in making this device available to American patients. Based on extensive research and high quality clinical data, we believe the Sapien 3 valve has the potential to transform patient care in the U.S.,” Edwards corporate veep of transcatheter heart valves Larry Wood, Edwards said in prepared remarks
Earlier this year, Edwards CEO Michael Mussallem said the company was hopeful the FDA would approve the Sapien 3 this year.
An analyst’s letter, released yesterday from Leerink partners, said the early approval will drive upside of its 2015 sales and earnings per share estimates of $2.39 billion and $4.25 respectively, and consensus at $2.40 billion and $4.28.
“To us, this approval in both inoperable and high-risk patients positions EW for share gains in the U.S. in the near term, much as it did upon launch in Europe,” the letter said. “Our MedaCorp physician conversations over the last 18+ months lead us to view Sapien 3 as a best-in-class valve, with low rates of stroke and paravalvular leak as well as significantly improved ease-of-use.”
CFO Scott Ullem said last year that 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 Sapien 3 is Edwards’s 3rd-generation Sapien heart valve, originally approved by the FDA in 2011.