A Medical Device Daily
Abiomed (Danvers, Massachusetts) reported conditional approval by the FDA of its investigational device exemption for the Impella 5.0 catheter-based circulatory support systems. Clinical trials in the U.S. are to begin immediately.
The Impella Recover 5.0 devices have been used to treat more than 250 patients in Europe 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, including Abiomed's AB5000 and BVS 5000 Circulatory Support Systems.
The pilot study for the Impella 5.0 will enroll up to 20 patients at seven U.S. sites, and 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.
“We are excited to receive this approval for the Impella 5.0, as we believe this technology will provide surgeons with a potent, minimally invasive, circulatory support system. Abiomed's results with the Impella 5.0 in Europe have been excellent and we look forward to ultimately bringing this technology to the U.S. through this study,” said Michael Minogue, chairman, CEO and president.
The Impella 5.0 technology consists of catheters that can be introduced percutaneously through a cut-down and surgically. Other Impella devices currently available in Europe under CE-mark approval include the Impella 2.5 and the Impella RD.
The Impella 5.0 pumps can achieve flows of up to 5.0 liters per minute, and actively unload the ventricle, reducing myocardial workload and oxygen consumption while increasing cardiac output and coronary and end-organ perfusion.
The Impella 5.0 support systems are intended to be used for up to seven days as left ventricular cardiac assist devices. The systems are comprised of the Impella mobile console, the Impella bearing purger and the Impella 5.0 catheter-based rotary blood pumps.