Abiomed Expects Good Result From Halted Impella Trial

Article preview from "The Gray Sheet" - December 8, 2010

Despite having to halt its large study evaluating the Impella 2.5 circulatory support system in high-risk, non-emergent angioplasties because it was unlikely to meet its endpoint, Abiomed insists the partial dataset will ultimately accelerate adoption of its lead product.

Abiomed Expects Good Result From Halted Impella Trial

Article preview from "The Gray Sheet" - December 8, 2010

Despite having to halt its large study evaluating the Impella 2.5 circulatory support system in high-risk, non-emergent angioplasties because it was unlikely to meet its endpoint, Abiomed insists the partial dataset will ultimately accelerate adoption of its lead product.

The firm blames the trial halt on the increased use of an additional interventional technique by investigators in the Impella arm compared to the control group. It says that detailed subgroup analyses of the collected data will prove the short-term percutaneous cardiac assist device has an important role to play in at least a portion of the 60,000 or so high-risk percutaneous coronary interventions (PCI) performed in the U.S. annually.

Lead investigators plan to present such analyses next spring at the American College of Cardiology annual meeting. Abiomed hopes the presentation will help get the 510(k)-cleared Impella written into PCI guidelines.

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