This approval is conditional upon the company’s submission of additional information to the FDA over the next 45 days. 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). 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.
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 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. 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 approval at each participating hospital and requisite training, the company plans to ship Impella 2.5 disposables and Impella consoles to enrolled sites. In addition to this AMI study, Abiomed is currently conducting a high-risk PCI pivotal study for its Impella 2.5 device. The Impella 2.5 is also under review by the FDA for 510(k) clearance which, if approved, would allow Abiomed to immediately begin selling the device to an estimated 14,000 interventional cardiologists at 1,900 hospitals in the US.
The Impella 2.5 device is a percutaneous device intended to provide the patients assistance of up to 2.5 liters of blood flow per minute. It is already used outside the US to treat conditions such as acute myocardial infarction (AMI), cardiogenic shock, and low output syndrome. The Impella 2.5 provides a new treatment option that aims to improve patient outcomes through a new standard of care.