ABMD shares closed up 18.0% at $72.48 on the news. The stock is up some 94% this year.
The PMA indication is for up to 6 hours of treatment using the Impella 2.5, a tiny pump that’s threaded into the heart’s left ventricle to support blood flow during percutaneous coronary interventions for high-risk patients. Physicians may elect to leave the Impella 2.5 in place for longer than 6 hours "due to unforeseen circumstances," Abiomed said.
The decision to treat with PCI or open heart surgery is made by a "heart team" that includes a cardiac surgeon, much like the protocol used in deciding whether to treat aortic stenosis with surgery or a transcatheter aortic valve implant, the Danvers, Mass.-based company said.
“If the protocol determines that PCI is appropriate, Impella is the only hemodynamic support device proven safe and effective for high-risk PCI," Abiomed said.
"The heart team approach has evolved into a mainstream practice recognized by the guidelines for determining the need for PCI versus surgery and will continue to act as a platform for the screening and determination of the appropriate revascularization treatment for this high risk patient population," Dr. William O’Neill of Detroit’s Henry Ford Hospital said in prepared remarks. "The rigorous data from FDA clinical trials such as Protect I and Protect II demonstrate that complex, high-risk patients undergoing protected PCI with Impella 2.5 support experience reduced adverse events, improved quality of life and are able to return home faster with fewer repeat procedures."
The FDA’s Circulatory Devices panel recommended in late 2012 that devices like Abiomed’s flagship Impella 2.5 device be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s less-stringent 510(k) clearance protocol. Last October Abiomed said it had reached a deal with the federal safety watchdog on the indication for Impella 2.5.
"Abiomed would like to thank the FDA and all the dedicated caregivers and investigators for this achievement. The FDA approval of the Impella 2.5 device is one of our most significant milestones, representing a clinical advancement for physicians and patients. The FDA’s recognition of this elective and urgent patient population is an important acknowledgement of their growing need for treatment. As heart disease patients get sicker, more complex, and desire minimally invasive solutions, there are few options available to them to help improve their quality of life in a cost effective manner," chairman, president & CEO Michael Minogue said in a statement. "We are excited that Impella has been recognized as a device that can potentially become the new standard of care with a ‘1st-of-its-kind’ approval."