Abiomed Launches Plan To Counter Unfavorable Impella Data
Abiomed is trying to counter the negative publicity created by the recent publication of retrospective studies showing higher costs and worse outcomes in coronary intervention cases with Impella than in comparable procedures with intra-aortic balloon pumps. The company insists this analysis is deeply flawed.
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The circulatory support device company is transforming into “Abiomed 2.0” by investing in remote monitoring technology as well as online customer service and virtual training programs.
Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.
In a letter sent 21 May, the US FDA tells physicians the benefits of Abiomed’s Impella RP right-heart circulatory support device outweigh the risks in appropriately selected patients. In February, the agency warned doctors that the postmarket study of the device showed worse survival than the premarket clinical trial.