Abiomed’s (NSDQ:ABMD) Impella 2.5 beat out intra-aortic balloon pump therapy in supporting heart failure patients undergoing percutaneous coronary intervention, according to newly released study results.*
The Impella 2.5 device is a percutaneous "micro heart pump" with integrated motor and sensors, which the company bills as the world’s smallest heart pump.
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 as well as a reduction in repeat vascularization when compared to IABP therapy during PCIs, according to the report published late last month in the journal Circulation.
ABMD shares gained a few points today, trading 1.5% higher at $22.66 as of about 1:35 p.m.
That’s more good news for the device maker, which earlier this year posted record Q1 sales and 30% year-over-year Impella sales growth, which Abiomed chairman, president & CEO Michael Minogue told investors was a sign that the technology was becoming the new standard of care for percutaneous circulatory support in the U.S.
"The company is off to a fast start this fiscal year, solidifying our position in the industry as one of the fastest growing profitable medical device company," Minogue told investors during a conference call last month.
Abiomed’s Impella line makes up the bulk of its sales, accounting for $107 million during the fiscal year ended March 31. The company attributed most of that to disposable product sales of Impella 2.5.
Abiomed is currently conducting its USpella study, "the first U.S. multicenter observational registry collecting clinical data and outcomes for patients supported with Impella 2.5 and 5.0 during elective, urgent and emergent procedures," according to a company report. More than 40 hospitals in the U.S. and Canada are participating in that study.
Abiomed is expecting to win a nod from the FDA for its next-generation Impella cVAD heart pump, Minogue said on the call. The Impella cVAD in April won CE Mark approval in the European Union, where the medical device company gave the heart pumps away for free.
Abiomed is also expecting to win a nod from the FDA for its next-generation Impella cVAD heart pump. The Impella cVAD in April won CE Mark approval in the European Union, where the medical device company gave the heart pumps away for free.
*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.