A Medical Device Daily

Abiomed (Danvers, Massachusetts) said it recently received a written response from the FDA outlining four areas of concern for which they requested additional information related to the company’s submission for 510(k) clearance of the Impella 2.5.

Two of the questions requested clarification and additional information related to labeling within the 510(k) submission. A third question requested additional information related to bench-testing of the device. A fourth question requested that the company provide an updated clinical review of the global experience with the Impella 2.5 since the original 510(k) submission, including up to date information from the U.S. safety pilot clinical trial for the Impella 2.5.

“We continue to work diligently with the FDA to provide clarification on existing data and additional information related to our 510(k) clearance submission for the Impella 2.5,” said Michael Minogue, president/CEO and chairman of Abiomed. “While there are no guarantees for a 510(k) clearance, we remain confident that we are on a 510(k) path with a potential clearance sometime between November 2007 and March 2008.”

Abiomed makes products that provide circulatory support to acute heart failure patients.