Edwards Lifesciences Corp. (NYSE:EW) will get its much-anticipated date with the FDA for its flagship Sapien transcatheter heart valve device on July 20.
The federal watchdog agency’s circulatory system devices advisory panel will review the company’s pre-market approval application for the Sapien system. If it gets a green light from the panel, it should gain approval from the watchdog agency for commercial sale in the U.S., possibly by the end of the summer (the FDA is not bound by its advisory panels’ recommendations, but usually follows their guidance). Edwards filed its PMA application in October 2010 and has staked its flag on an October 2011 release, sinking about $40 million into a launch that CEO Michael Mussallem said will allow the company to compete in 200 to 400 centers in the U.S.
Edwards officials have said they believe a green light from the FDA for Sapien could bring in $20 million to $25 million in U.S. sales. Edwards has been riding a wave of positives for the device, which performed well in an eagerly awaited study early this year.
Sapien sales in the EU helped drive solid results for Edwards’ transcatheter heart valves unit during the first quarter. The division posted sales of $72.7 million, up 85.7 percent over Q1 2010. The CE Mark, for a larger size of the Sapien device, helped add $2 million to $3 million to the tally.
Edwards has already raised its outlook on the rest of the year, boosting its 2011 sales forecast by $70 million to $1.66 billion to $1.74 billion and increasing its diluted EPS prediction to $2.01 to $2.07, chairman and CEO Michael Mussallem said.
The panel date means Edwards is still on track to have a healthy head start on rival Medtronic Inc. (NYSE:MDT) and its CoreValve System in the robust replacement heart valve market. 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 the therapy, which involves replacing the diseased aortic valve with an implant inserted via catheter, rather than with open heart surgery.
In the same announcement, the panel said it will also be reviewing the EXCOR Pediatric Ventricular Assist Device (VAD) made by Berlin Heart, Inc. The product is a “pneumatically-driven extracorporeal ventricular assist device” designed to provide bridge-to-transplant mechanical support to the heart.
As per standard procedure, the committee will release background material on the device two days prior to the panel.