The FDA today gave approval to Abiomed to proceed with a clinical study of the Impella® 2.5 Circulatory Support System for patients with acute myocardial infarction (AMI). (2.5 refers to the ability of the device to augment the cardiac output by 2.5 liters per minute.) We’ve been following Impella, a ventricular assist device designed for percutaneous placement in the catheterization lab, for at least four years now, ever since it was designed and manufactured by Impella CardioSystems AG of Germany.
From today’s announcement:
The AMI shock study will determine the safety and effectiveness of the Impella 2.5 as a left ventricular assist device for heart attack patients as compared to optimal medical management with an Intra-Aortic Balloon Pump (IABP). According to a recent American Heart Association report, approximately 865,000 AMI patients are treated annually in the U.S. The study is approved under category B2 status and the trial sites are eligible for full reimbursement from the Centers for Medicare and Medicaid Services (CMS).
The randomized study, at up to 150 hospitals, is comprised of two arms; those patients that receive the Impella 2.5 for up to five days as a left ventricular assist device (VAD) and patients that receive IABP therapy. The study will compare 192 Impella 2.5 patients to 192 IABP patients relative to a composite end point comparing safety and efficacy. The primary endpoint will be a composite endpoint of major events assessed at 30 days post-PCI. These major events include but are not limited to: death, acute renal failure, and need for a major cardiovascular operation. The secondary endpoint will be a composite of cardiac function such as ejection fraction, requirement for inotropic support and cardiac power output. Following Institutional Review Board (IRB) approval at each participating hospital and requisite training, the Company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites.
Product page: Impella 2.5…