The Impella CP device, which won pre-market approval earlier this year for up to 4 hours of treating patients for cardiogenic shock after acute myocardial infarction or cardiac surgery, can now be used to for up to 6 hours during high-risk percutaneous coronary interventions, Danvers, Mass.-based Abiomed said.
“This latest approval for Impella expands the hemodynamic options for the cardiovascular community to effectively revascularize severely ill patients who have limited options and high mortality risk,” Dr. Jeffrey Moses, of New York City’s Columbia University Medical Center, said in prepared remarks. “Backed by clinical data and real world experience since 2008, interventional cardiologists working with their heart teams to identify complex PCI candidates can perform complete revascularization on previously untreatable patients to improve their quality of life and their native heart function.”
The Impella CP initially won 510(k) clearance from the FDA in September 2012, but the federal safety watchdog’s Circulatory Devices Advisory panel later decided that the Impella pumps are Class III devices requiring PMAs. It took nearly 4 years, but Abiomed and the FDA eventually came to terms over the indications for the devices in March.
ABMD shares were trading at $113.46 apiece today in mid-morning activity, up 0.5%.