(AP) — Abiomed, Inc. said it is ending a study using its Impella heart product because the results will likely fall short of the main goal of reducing major adverse events related to surgery. The company said it based the move on a recommendation from an independent monitoring board.
The Impella Cardiac Assist Device system allows surgeons to implant a device to keep blood flowing during and after surgery and prevent heart failure. The current study focused on high-risk angioplasty patients receiving support with Impella compared with patients receiving support with an intra-aortic balloon pump. Impella patients had a 38 percent rate of major events, compared with 43 percent on the intra-aortic balloon at 30 days. A subpopulation of patients not receiving an atherectomy had a 32 percent rate, compared with 43 percent on the intra-aortic balloon.
An atherectomy is a surgery that uses a catheter to remove plaque from blood vessels. The company said it faced "confounding" results in a population of patients receiving the surgery, with 72 percent experiencing major adverse events, compared with 46 percent on the intra-aortic balloon.