Edwards Lifesciences Corp. (EW) won approval for the first less-invasive heart valve to be marketed in the U.S. to treat patients who are too sick for chest-opening surgery.
The Food and Drug Administration cleared the device to treat patients with a narrowing of their aortic valve, the agency said today in a statement posted on its website. The Edwards device is the first so-called transcatheter valve sold in a U.S. market estimated to reach $1.1 billion by 2014, according to a report from Bloomberg Industries.
Edwards, based in Irvine, California, expects U.S. sales of the valve, called Sapien, to reach as much as $25 million in the first three months after its debut and $150 million to $250 million in the first full year, Mike Mussallem, chairman and chief executive officer, said Oct. 19 on an earnings call. The company plans to price Sapien about $30,000, he said.
“This day marks an important milestone for inoperable American patients who have long been awaiting a therapeutic option for the often debilitating symptoms associated with severe aortic stenosis,” Mussallem said today in a statement after the approval.
Edwards rose 4.2 percent to $77.48 at 6:05 p.m. New York time in extended trading. The company’s shares have declined 8 percent this year.
The Sapien valve has been available in Europe since 2007. Transcatheter sales generated $206 million last year for Edwards, according to data compiled by Bloomberg.
About 300,000 people in the U.S. suffer from severe aortic stenosis, a narrowing of the valve, according to Edwards. Two- thirds undergo standard chest-cracking surgery to replace the valve, while the risk of surgery may be too high for the rest.
The Sapien can be implanted by a catheter threaded through the leg or ribs rather than conventional chest-opening surgery.
The Centers for Medicare and Medicaid Services may pay for the transcatheter valve only if it is used in a specialized heart center by a team with appropriate training because of the high risk of stroke and death associated with the device, the agency said. The Society of Thoracic Surgeons and the American College of Cardiology requested the formal national coverage decision Sept. 22.
Edwards accepted many of the restrictions sought by the societies in comments posted Oct. 27 to on Medicare’s website.
The coverage decision will be completed June 26, according to the agency. Minneapolis-based Medtronic Inc. (MDT) began a clinical trial in December in the U.S. of a rival device.
The thoracic surgeons and cardiologists are also working on guidelines for training and qualifying physicians and centers to perform surgery with transcatheter valves. Center qualifications may limit Sapien use, Michael Weinstein, an analyst with JPMorgan Chase & Co. in New York, wrote Oct. 17 in a note to clients.
“Not every patient can travel and not everyone will have access to the largest centers,” he said.
Sixty-nine percent of patients who received the Sapien valve lived after one year compared with 50 percent in a clinical trial group receiving standard therapy, according to an FDA staff report released July 18. The agency called the results “an impressive reduction of mortality” while raising concerns that not much data exists beyond two years.
In the clinical trial, 20 patients, or about 11 percent, who received the device experienced a stroke after one year compared with eight patients, or 4.5 percent, who were treated with other therapy, such as balloon aortic valvuloplasty, according to the report.
Edwards also is seeking FDA approval of Sapien in high-risk patients who are able to undergo surgery. The company expects approval in the second quarter of 2012, Mussallem said.
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