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WASHINGTON -- The FDA approved the Sapien Transcatheter Heart Valve for treatment of patients too sick to undergo open-heart surgery to repair calcified aortic valves.
The Sapien valve, from Edwards Lifesciences, is a replacement valve that doesn't require major surgery.
In July, an FDA advisory panel voted 9-0, with one abstention, to recommend approval for the Sapien transcatheter heart valve.
The Sapien valve is approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus.
The product label advises that a heart surgeon should be involved in determining if the Sapien valve is an appropriate treatment for the patient. It is not approved for patients who can be treated by open-heart surgery. As a sign of the significance of this device coming to market, the American Heart Association will feature a special session on transaortic valve replacement at its meeting later this month.
The AHA's program chair, Elliott Antman, MD, of Brigham and Women's Hospital in Boston, told ľֱ that the TAVI session will include leading surgeons, interventional cardiologists, and general cardiologists, all of whom will wrestle with "the ways in which this device will change practice."
The FDA panel had analyzed results from the two-part PARTNER trial, which tested the device in patients too sick to undergo surgery, as well as in patients who were candidates for surgical repair.
Patients receiving the Sapien valve experienced two-and-a-half times more strokes and eight times as many vascular and bleeding complications than patients who did not receive the implant; however, they were more likely to survive one year after surgery. After a year, 69% of the Sapien patients were alive compared with 50 percent of those who received an alternative treatment, such as balloon valvuloplasty.
Both the Society of Thoracic Surgeons (STS) and the American College of Cardiology (ACC) have been working with the FDA and the Centers for Medicare and Medicaid Services (CMS) to facilitate the creation of the national Transcatheter Valve Therapy registry that will serve as a platform for continued evaluation of post-market experience with this and future transcatheter devices and procedures for the treatment of aortic stenosis, according to the FDA.
CMS's decision regarding coverage for transcatheter aortic valve implantation (TAVI) is expected sometime this month.
Both the STS and ACC have endorsed a national coverage determination, while the Society for Cardiovascular Angiography and Interventions (SCAI) supports a local coverage determination.
"The benefit of a national coverage determination is that it restricts the use of the technology to larger experienced centers, mostly those who participated in the trials," Christopher White, MD, president of SCAI told ľֱ.
"A local coverage determination, however, allows you to control where the resources go regionally," White said.
SCAI is still smarting after the national coverage determination for carotid stenting. He said that many patients "fall through the cracks" and cannot receive stenting because of the restrictions placed upon it by CMS. But if the decision were in the hands of local carriers, at least providers could appeal in individual cases.
"A local coverage determination is a more personalized way to deliver medicine," he said.