The FDA’s Circulatory System Devices Panel yesterday voted to keep non-roller type cardiopulmonary blood pumps at Class III status, including the Impella, which has U.S. market clearance under the FDA’s less stringent 510(k) pathway.
Abiomed president, chairman and CEO Michael Minogue thanked its physician collaborators for their work in helping the company make it case to the FDA’s 515i committee, the federal watchdog’s classification review program.
"We look forward to collaborating with the FDA on next steps and agree with the 515i Panel’s feedback that our existing data, combined with our U.S. registry, position us to work with the FDA to submit a PMA application," Minogue said in prepared remarks. "We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients."
The device maker must now submit a new application to keep Impella on the market, but the devices won’t have to come off the shelves in the mean time. The 515i program allows for devices to stay on the market while companies to resubmit FDA applications and undergo review, according to a press release.
"Following yesterday’s panel recommendation, the next steps in the 515i process include FDA issuance of a Proposed Final Order, followed by a period of public comment, FDA issuance of a Final Order, and then submission of Pre-Market Approval applications by manufacturers with devices in the category," according to Abiomed. "Throughout this series of reclassification steps, Abiomed will continue to market the Impella family of heart pumps and looks forward to working with FDA to submit the necessary clinical data under the PMA application process."
ABD shares took a hit today, losing 6.7% to trade at $12.02 as of about 12:35 p.m.