November 2, 2011 (Silver Spring, Maryland) — The US Food and Drug Administration has approved the first-ever transcatheter valve for the treatment of inoperable aortic-stenosis disease, the Sapien (Edwards Lifesciences) .
The FDA's decision comes within months of a positive opinion from its Circulatory System Devices Committee, which, back in July, voted 7 to 3 that the device demonstrated reasonable assurances of safety, 9 to 1 that the device demonstrated reasonable assurances of efficacy, and 9 to 0 (with one abstention) that its benefits outweighed the risks.
The valve device is approved for "patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus," an FDA press release notes. "The product label advises that a heart surgeon should be involved in determining if the Sapien [transcatheter valve] is an appropriate treatment for the patient."
That indication covers patients similar to those enrolled in PARTNER cohort B.
As previously reported by heartwire , PARTNER cohort B showed that patients treated with transcatheter aortic-valve implantation (TAVI) experienced a relative risk reduction in all-cause mortality of 46% compared with best medical therapy (a 20% absolute difference). Cardiovascular mortality risk was reduced by 61% compared with patients receiving the best medical care, including balloon valvuloplasty. Risk of a composite end point of dying or needing repeat hospitalization was also lower in TAVI-treated patients, although the risk of stroke and vascular complications was higher in the TAVI group.
The device manufacturer has submitted a separate premarket approval (PMA) application to the FDA for use of the device in high-risk surgical patients (those studied in PARTNER cohort A, which included patients who received the device via a transapical approach). This PMA will be the focus of a separate advisory committee meeting.
The next big question to be resolved is Medicare coverage of the device. As reported by heartwire , the Centers for Medicare and Medicaid Services (CMS) announced in late September that it had opened a "national coverage analysis" (NCA) for TAVI devices in response to a request from the American College of Cardiology (ACC) and the Society for Thoracic Surgeons (STS). A 30-day comment period on that proposed coverage lasted until October 28.
Edwards is expected to price the device at around $30,000 to $35,000, although experts have told heartwire that the actual costs of the device, procedure, and patient care will climb up to nearly twice that amount.
Heartwire from Medscape © 2011 Medscape, LLC
Cite this: Sapien Transcatheter Valve Approved for Aortic-Valve Disease - Medscape - Nov 02, 2011.