Edwards earns first FDA approval for heart valve in intermediate-risk patients

human heart

Correction: This article has been changed to indicate that the approval is an expansion for the treatment of intermediate-risk patients. The approval for high-risk patients was issued in 2015.

Edwards Lifesciences has earned an expansion on its FDA approval for its SAPIEN 3 transcatheter aortic heart valve with the Commander Delivery System. The extension covers the treatment of intermediate-risk patients.

Courtesy of Edwards Lifesciences
This extension represents the first ever transcatheter aortic valve that has been approved in the U.S. for use in intermediate risk patients, according to Bram Zuckerman, the FDA’s director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health. “This new approval significantly expands the number of patients indicated for this less invasive procedure for aortic valve replacement,” Zuckerman explained.  

Intermediate risk patients fall into a category where there is a greater than 3% risk of death within 30 days of open-heart surgery, which is the gold standard for aortic valve replacement for those patients. However, open-heart surgery involves a larger incision and longer recovery time than treatment with a transcatheter aortic valve does.

Approval of the Edwards’ SAPIEN 3 valve means intermediate-risk patients now have the option for a less-invasive procedure than before.

"The intermediate-risk approval of the SAPIEN 3 valve is a major milestone, since it provides a less-invasive therapy that has demonstrated better outcomes for aortic valve patients, and is supported by the largest and rigorous comparative body of evidence for the treatment of aortic stenosis," said Larry L. Wood, Edwards' corporate vice president of transcatheter heart valves, in the announcement.

According to Danielle Antalffy of Leerink, this approval puts Edwards in position for solid growth. "While largely as expected, intermediate risk positions EW for sustainably strong double-digit growth over the near-to-medium term," the analyst said in a report. "And the incremental upside from here could come from more rapid adoption than currently reflected in this much-larger indication representing the size of at least high risk + inoperable combined."

In 2015, SAPIEN 3 earned approval for the treatment of high-risk patients suffering from severe, symptomatic aortic stenosis. "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,” Leon said in the 2015 announcement. “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."

SAPIEN 3 was approved based off of the PARTNER II study which looked at 583 high-risk patients. The valve is available in sizes ranging from 20mm to 29mm and has a cuff of fabric that surrounds the valve to protect against paravalvular leak.

SAPIEN 3 has been commercially available in Europe since January 2014, and has been used to treat over 150,000 patients globally.

- here's Edwards' announcement
- and the FDA's release

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