A Medical Device Daily
Abiomed (Danvers, Massachusetts) yesterday reported the start of the IMPELLA 2.5 pilot study in the U.S. with the enrollment of the first patient at William Beaumont Hospital (Royal Oak, Michigan). Abiomed bills the Impella 2.5 as the world's smallest ventricular assist device (VAD). It is currently CE-marked.
The treatment uses the Impella 2.5 VAD during high-risk angioplasty to provide hemodynamic support, with more than 2 liters of flow for the patient throughout the procedure. In this case, the patient had previously received a bypass and a defibrillator, had poor heart function and needed angioplasty to open a complex lesion in the vessel supplying blood to the heart.
The Impella 2.5 was implanted through the groin, and the patient was discharged from the hospital about 48 hours afterward.
“The Impella 2.5 technology is revolutionary and one of the most exciting new products I have seen in interventional cardiology,” said William O'Neill, corporate director of cardiology, William Beaumont Hospital System. “The ease of insertion of Impella and its unique capability to unload the left ventricle and enhance flow to the body improved the patient safety during this complex, high-risk angioplasty procedure performed by Dr. Simon Dixon.”
“We believe Impella 2.5 will change the standard of care in cath labs worldwide,” said Michael Minogue, president/CEO and chairman of Abiomed. Abiomed said that it would conduct a conference call in the future to outline the further details of the trial.
The company on May 25 reported receiving FDA approval to commence its U.S. pilot clinical trial for the Impella 2.5 VAD during high-risk angioplasty and subsequent to the procedure, if needed, for up to five days as a left VAD.
Abiomed makes products that assist or replace the pumping function of the failing heart. It manufactures the AB5000 Circulatory Support System and the BVS 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts.