A Medical Device Daily

Abiomed (Danvers, Massachusetts) said it has received conditional approval from the FDA to begin its clinical trial in the U.S. for the Impella 2.5 circulatory support system. The study will determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an intra-aortic balloon pump (IABP) during “high-risk” angioplasty procedures. The study inclusion criteria have been extended to include patients with triple vessel disease with low ejection fraction.

The study will compare 327 Impella 2.5 patients to 327 IABP patients and is comprised of two arms made up of patients receiving the Impella 2.5 for up to five days as a left ventricular assist device and patients receiving IABP therapy. Following IRB approval at each participating hospital and requisite training, the company plans to ship Impella 2.5 disposables and Impella consoles to the pivotal sites.

The Impella 2.5 is a left percutaneous device inserted while in the cath-lab, which provides patients with up to 2.5 liters of blood flow per minute. It is the world’s smallest VAD and has been used to treat conditions such as acute myocardial infarction, cardiogenic shock, and low output syndrome under CE mark approval in Europe. Due to a rise in conditions such as triple vessel disease in patients with poor cardiac function, which is caused by coronary vessel blocks in three vessels of the heart, the Impella 2.5 provides a new treatment option that aims to improve patient outcomes.

Abiomed makes products that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery.