A Medical Device Daily

Abiomed (Danvers, Massachusetts) said it has received a written response from the FDA related to the company’s submission for 510(k) clearance of its Impella 2.5 circulatory support device.

The company said that there were no new questions on the submission presented by the FDA to it in this response.

It said that FDA communicated that the first three areas of concern have been resolved. The clinical data provided by Abiomed has been accepted by the FDA and the labeling has been agreed upon. The remaining request for information involves comparative bench testing relative to one of the predicate devices proposed.

Usually bench testing is conducted to predict clinical results. But Abiomed said that in the case of the Impella 2.5 510(k) submission, the clinical results have been accepted and the bench testing is requested as another data set. “We are actively working with the FDA to design and complete this bench testing,” the company said in a statement.

“We are pleased with the most recent update from the FDA and will work diligently on a thorough and expedient response to this request for additional information,” said Michael Minogue, president/CEO of Abiomed. “As we have stated since our original submission, there are no guarantees but we remain confident that we will receive 510(k) clearance for the Impella 2.5.”