Updated 11/3/2011 at 2:00 p.m.
Edwards Lifesciences Corp. (NYSE:EW) is the first to bring a catheter-based aortic valve to the U.S. market with FDA pre-market approval for the Sapien transcatheter device today.
Edwards has been hanging fire since July, when an FDA advisory panel recommended that the federal watchdog agency approve the Sapien device.
The clearance marks the first time the FDA has given the green light to a device enabling coronary valve replacement without open-heart surgery, according to a press release.
Hospital sites involved with Sapien’s clinical trials can now buy the device directly from Edwards and offer it to patients, company spokeswoman Sarah Huoh told MassDevice. Edwards expects U.S. sales between $20 million and $25 million in the first 3 months after launch, and up to $150 million to $250 million in the first year, she 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," chairman & CEO Michael Mussallem said in prepared remarks.
Sapien is made of cow tissues and polyester supported with a stainless steel mesh frame, according to an FDA press release. The device is compressed into the end of a catheter, which is slightly wider than a pencil, and inserted into the femoral artery through an incision in the leg. A physician threads the catheter to the heart where the Sapien device is released and expanded using a balloon.
The device is only approved for patients who are at too high a risk for open-heart surgery.
Edwards filed its PMA application in October 2010, sinking about $40 million into a launch that chairman & CEO Michael Mussallem has said will allow the company to compete in 200 to 400 medical centers in the U.S.
News surrounding Sapien over the past few months has sent the company’s shares on a roller coaster driven by rumors and fears.
When an FDA advisory panel voted strongly in favor of Sapien’s approval on July 21 EW shares lost 4 percent on The Street, a surprising result considering that Edwards had been on a hot streak for more than a year, jumping nearly 60 percent since July 21, 2010. EW shares closed at $82.55, compared to $87.53 the day before.
Shares sank again at the end of September, losing 7 percent when the Centers for Medicare & Medicaid decided to review its coverage policy for a type of replacement heart valve. EW shares, which ended Sept. 29 at $75.87, sank 6 percent to $71.28 by close of Sept. 30.
Earlier this month EW shares took a 5 percent dive on a rumor that FDA approval could be delayed, closing at $68.53 on October 17 from $72 the day before. The sell-off started after Wells Fargo analyst Larry Biegelsen reported that a member of the FDA advisory panel that recommended approval of Sapien said the device wouldn’t get a green light until April 2012. Edwards denied the rumor, saying that it still planned on approval “any day now.”
Shares bumped up 2.5 percent today to $76.18 in early afternoon trading, compared to last night’s closing price of $74.37.
The Sapien heart valve is cleared for sale in 27 EU countries and in other countries that recognize the CE Mark.
The companies have duked it out in court and the EU market for more than four years. That may be peanuts compared to the U.S. market, however, at least according to some estimates. About 100,000 U.S. patients — roughly a third of the global market — are candidates for transcatheter aortic valve replacement.