The FDA has approved ABIOMED's pilot clinical trial in the U.S. for the IMPELLA 2.5, a minimally invasive ventricular assist device, the company announced May 25.
The IMPELLA 2.5 is designed to provide support during high-risk angioplasty, which involves the insertion of a catheter-guided balloon to open a narrowed coronary artery. A stent, a wire-mesh tube that expands to hold the artery open, is usually placed at the narrowed section.
The pilot trial will be conducted with "no more than seven trials and 20 patients," ABIOMED said. The Danvers, Mass.-based company must submit additional information to the FDA over the next 45 days to complete the approval process for its investigation.