Abiomed, FDA come to terms on Impella PMA requirements

Abiomed (NSDQ:ABMD) said yesterday that it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels.

Danvers, Mass.-based Abiomed said the federal safety watchdog agreed on the indication for treating patients in cardiogenic shock after a heart attack or cardiac surgery with its Impella 2.5, Impella CP, Impella 5.0 and Impella LD devices.

“Based on the information available to the company to date, including multiple discussions with the FDA, the company no longer anticipates the requirement for an FDA advisory panel prior to the PMA approval,” the company said in a regulatory filing.

Abiomed said it submitted data from its 415-patient Recover 1 study, a review of data from another 692 patients in 17 trials, and a safety analysis of more than 24,000 patients using the FDA’s medical device reporting database.

“The company believes this is the most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic shock population,” the company said.

Leerink Partners analyst Danielle Antalffy said Abiomed’s timeline for approval is now “well ahead of the previously expected August 2016 timeframe.” Although cardiogenic shock already represents more than 40% of Impella sales, Abiomed hasn’t had an aggressive marketing push under its 510(k) clearance and has only a roughly 5% penetration into the 100,000-patient market, Antalffy wrote this morning in a note to investors.

“With a PMA approval for its suite of products in cardiogenic shock, ABMD will now be able to aggressively market to and train physicians and nurses using its extensive supportive clinical dataset – the most comprehensive ever in this indication,” she wrote.

“Upon approval, Impella will be the only temporary circulatory support device – vs. intra-aortic balloon pumps and [extracorporeal membrane oxygenation] – with ‘safe and effective’ on the label, something we believe will drive accelerating adoption and utilization. This is on top of the ~121,000-patient protected [percutaneous coronary intervention] market opportunity already being addressed by Impella 2.5 and also just ~5% penetrated,” Antalffy wrote.