Edwards Lifesciences to Introduce Less-Invasive Heart Valve in the United States

Edwards Lifesciences Corp. will market the Sapien, the first less-invasive heart valve for patients too sick for chest-opening surgery in the United States. The device instead is implanted by a catheter threaded through the leg or ribs.

An advisory panel to the U.S. Food and Drug Administration (FDA) determined the Sapien’s benefits to patients with a narrow aortic valve outweighed the device’s risks, namely stroke and hemorrhage. The ruling came in a 9-0 vote, with one abstention The panel earlier voted 7-3 that the Irvine, Calif.-based company’s valve is safe and 9-1 that it is effective.

If approved, the Sapien would be the first so-called transcatheter valve sold in a U.S. market, which is estimated to reach $1.3 billion by 2014, according to reports. The valve has been available in Europe since 2007.

“We feel this reduction in mortality in inoperable patients outweighed the significant risks with the device, most notably stroke and vascular injury,” Julie Swain, staff fellow with the FDA’s circulatory support and prosthetics branch in the division of cardiovascular devices, told the panel.

According to Edwards, about 300,000 people in the United States suffer from severe aortic stenosis, a narrowing of the aortic valve. Two-thirds undergo standard chest-cracking surgery to replace the valve, but the risk of surgery may be too high for the remaining third.

“We are pleased with the panel’s recommendation,” Michael A. Mussallem, Edwards’ chairman and CEO, said in a statement. “This represents another important step on the path to what we hope will lead to FDA approval.”

A July 18 FDA staff report revealed that 69 percent of patients who received the Sapien valve lived after one year compared with 50 percent in a clinical trial group receiving standard therapy. The agency called the results “an impressive reduction of mortality” while raising concerns that not much data exists beyond two years.

Panel concerns included the high percentage of death rates in a small group of patients enrolled in a continuing access program after the study was complete. Thirteen patients, or 32 percent, who received the valve died after one year in the continuing access program compared with 10 patients, or 20 percent, who received other therapy.

In the clinical trial, 20 patients, or about 11 percent, who received the Sapien valve experienced a stroke after one year, compared with eight patients, or 4.5 percent, who were treated with an alternate therapy, such as balloon aortic valvuloplasty. According to the FDA, Edwards underreported stroke in its analysis of the study by counting only “major strokes” though stroke severity wasn’t measured during the trial. One hundred patients, or 60 percent, who received the valve experienced complications such as blood clots after one year, compared with 25 patients, or 14 percent, who were treated with other therapy.

The FDA staff recommended a post-approval study to provide long-term follow up data. Edwards plans to analyze the durability of the valve and patient quality of life for five years in additional post-approval research, according to a company presentation to the panel.