FDA wants PMA, not 510(k), for Abiomed's Impella
An FDA panel voted to keep temporary ventricular support devices such as Abiomed's ($ABMD) Impella under the Class III device designation, which, under a new set of rules, means they will need to file full PMAs even if they're already cleared.
The 515i Reclassification Panel is tasked with reviewing all 510(k) cleared Class III devices to make sure the proper safety and effectiveness controls are in place. Abiomed is taking for granted that the agency will issue a final order agreeing with the panel's ruling on Impella, and once the device is ruled a no-caveats Class III, the company will need to file a PMA application with the FDA.
That doesn't mean Impella is coming off the market, though. Abiomed says it will keep selling the device under its existing 510(k) clearance throughout the reclassification process.
"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," Abiomed CEO Michael Minogue said in a statement. "We welcome the opportunity for a PMA to strengthen our existing marketing clearances and expand the indications for Impella patients."
Impella remains Abiomed's cash cow, but the company has had to weather rumors that it might lose CMS reimbursement for the device and face investor ire after disclosing last month that the feds are investigating how it markets and labels the device. Now, some shareholders have launched a class-action suit, alleging that the company made false and misleading statements to investors.
For its part, Abiomed plans to "vigorously defend itself against the allegations," which it says "are without merit."
- here's Abiomed's statement