The Danvers, Mass.-based medical device company said it landed 510(k) clearance from the FDA for the percutaneous, catheter-based heart pump, which it says can provide peak flows of 4 liters per minute, about 80% of what a healthy heart can pump.
The Impella CP is intended for "partial circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods up to 6 hours) during procedures not requiring cardiopulmonary bypass,” according to a press release.
Last week, Abiomed shares popped on news that the its Impella 2.5 heart pump beat out intra-aortic balloon pump therapy in supporting heart failure patients undergoing percutaneous coronary intervention.*
Results of the 452-patient trial showed that the next-generation Impella system led to a reduction in adverse events in and out of the hospital and a reduction in repeat vascularization when compared to IABP therapy, according to the report published late last month in the journal Circulation.
ABMD shares were down slightly this morning, trading at $20.91 apiece as of about 10:40 for a 0.4% decline.
*Correction, Sept. 10, 2012: This article originally stated that the Protect II study compared IABP therapy during CABG procedures, rather than with percutaneous coronary interventions. Return to the corrected sentence.