March 18, 2008 - Abiomed Inc. received conditional approval from the FDA to begin its Impella 2.5 Circulatory Support System study in the U.S. under an investigational device exemption (IDE) for hemodynamically unstable patients undergoing a percutaneous coronary intervention (PCI) procedure due to acute myocardial infarction (AMI).
Although approval is conditional upon the Company's submission of additional information to the FDA over the next 45 days, the AMI shock study is designed to 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). The AMI shock study will offer Impella heart recovery technology to a broader population of acute patients in the catheterization lab, indicated to Michael R. Minogue, chairman, president and CEO of Abiomed.
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.
For more information: www.abiomed.com