Once-rejected CardioMEMs will get another shot at FDA approval for its Champion implantable heart failure monitoring systems when the agency’s Circulatory System Devices Panel convenes next month, according to a notice in the Federal Register.
St. Jude has put a lot of money into Georgia-based CardioMEMs, owning a 19% stake in the company as well as an option to buy. St. Jude recently deepened its interest in CardioMEMs with a $28 million debt financing that analysts said was based on "favorable due diligence."
The FDA previously rejected CardioMEMs’ PMA application on concerns about device efficacy and labeling, but analysts said that past rejected appears "more focused on semantics, less on data," and that the new chance at an FDA panel date signals a more likely approval for the Champion system.
The FDA in December 2011 rejected the Champion PMA, ruling that CardioMEMs failed to prove that its wireless, implantable heart monitor’s benefits outweigh its risks. The watchdog agency’s cardiovascular devices committee decided that a clinical trial of the device, designed to be the first permanent heart implant for a solely diagnostic purpose, was warped by the assiduous care given to its participants. That’s because the clinicians administering the single-blind trial knew which patients were implanted with the device and made sure they got specialized care.
The Champion system is set to go another round with the FDA panel, but it’s not clear what, if any, new data CardioMEMs will bring new data, Leerink Swann analysts wrote in a note to investors.
"It’s unclear as to whether the Oct. 9th FDA panel will include new data beyond the previously discussed CHAMPION clinical trial data," wrote analysts Danielle Antalffy and Robert Marcus. "But we’re inclined to believe that FDA does have some semblance of new data and/or material in hand for review at the Oct. 9th meeting. And despite the negative panel vote in Dec. 2011 – 4 to 6 that the benefits outweighed the risks of the CardioMEMs system – the CHAMPION clinical trial data seemed to be viewed largely favorably by the physician community."
CardioMEMs is fighting its way toward a market opportunity worth upwards of $1 billion, the analysts noted, approval would certainty signal a long-term upside for St. Jude’s bottom line.