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Abiomed to start trials of Impella circulatory support system after receiving FDA approval
New York, June 27 - Abiomed, Inc. said it plans to start immediately U.S. clinical trials of its Impella 5.0 catheter-based circulatory support system after receiving conditional approval by the Food and Drug Administration of its Investigational Device Exemption.
Impella Recover 5.0 devices are already available in Europe under CE Mark approval and have been used to treat more than 250 patients in need of cardiac support resulting from postcardiotomy cardiogenic shock, myocarditis, low cardiac output post-acute myocardial infarction, or post-coronary intervention procedures, or as a bridge to other circulatory support devices.
The pilot study in the United States will enroll up to 20 patients at seven sites.
The study will include postcardiotomy patients who have been weaned from heart-lung machines and whose hearts require added support to maintain good blood flow. The study will enroll those patients that would typically need more flow and hemodynamic support than provided by an intra-aortic balloon pump.
"The Impella micro-VAD technology is likely a window into the future where heart assist is headed. We look forward to evaluating the safety of this device in patients whose hearts are weakened after heart surgery. Because of the small size, they are assembled on a catheter that can be placed through an artery and into the heart," Bartley Griffith, chief of cardiac surgery and heart & lung transplantation at the University of Maryland School of Medicine and principal investigator of the study, said in a news release.
Abiomed is a Danvers, Mass., medical device company.
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