October 22nd, 2012
FDA Approves the Sapien Transcatheter Heart Valve for High-Risk Patients
Larry Husten, PHD
The FDA today approved an expanded indication for Edwards Lifesciences’ Sapien transcatheter heart valve (THV). The device can now be implanted in patients who are eligible for aortic valve replacement surgery but are at high risk for serious surgical complications or death. Previously the Sapien valve was approved only for use in patients who were not eligible for surgery.
The FDA also said the device could be delivered through both the transfemoral route and the transapical route. Previously the device could only be delivered through the transfemoral route.
“Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases that risk may be especially high,” said the FDA’s Christy Foreman, in an FDA press release. “The THV serves as an alternative for some very high-risk patients.” The FDA requires that before being deemed eligible for the Sapien valve a patient must be evaluated by a heart team, which includes a heart surgeon.
The new approval in high-risk patients was based on findings from the PARTNER A trial. The earlier approval in non-operable patients was based on findings from the PARTNER B trial.
The FDA will continue to require Edwards to evaluate the Sapien device through a national registry.
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