Medical device giant Edwards Lifesciences (NYSE:EW) won FDA approval to revise labeling for the Sapien transcatheter aortic valve implantation system, extending the device to a wider swath of patients.
The new approval allows Edwards to market Sapien for implantation via whatever method a physician chooses, rather than specifying insertion through the femoral artery. That means Edwards can officially market the device for use in patients who need alternative access points for the minimally invasive surgery.
The news had yet to make an impact on EW shares, which have been down about 1% for most of the day. Shares were trading at $69.27 as of about 4:55 p.m.
Approved by the FDA in November 2011, Edwards’ Sapien device remains the only transcatheter aortic valve implantation available on the U.S. market, initially indicated for treatment of inoperable patients. That indication was extended in October 2012 to include treatment of high-risk patients. The new approval expands Sapien’s reach even further.
"Just 2 years after the THV entered the market for a specific patient population, data from the TVTR was used to support FDA approval that expands patient access to a life-saving therapy," FDA medical device chief Dr. Jeffrey Shuren said in prepared remarks. "Medical device registries like the TVTR, not only play an important role in the FDA’s post market surveillance system, they also collect robust and timely data that can be used to identify additional patient populations that benefit from the therapy."
FDA regulators approved the extended indication based on data from Edwards’ Transcatheter Valve Therapy Registry and from European registries, including real-world patient data from "several thousand" procedures performed via non-femoral access routes. The data suggested that using non-femoral delivery routes had no effect on device performance, according to an FDA statement.
Edwards’ next-generation Sapien XT recently became the 1st transcatheter aortic valve implant to hit the market in Japan and is available in the U.S. as part of an 500-patient trial, which Edwards is ramping up after winning investigational device exemption from the FDA.