FDA panel casts doubt on CardioMEMS' heart failure diagnostic

CardioMEMS and investor St. Jude Medical ($STJ) have a lot riding on the Champion heart failure device, and the pair picked up a split vote from an FDA panel, with members divided on whether the diagnostic system is effective enough to merit approval.

The Circulatory System Devices Advisory Panel voted 11-0 that the device was safe and 6-4-1 that its benefits outweigh its risks but came down 7-4 that Champion is not effective, Healio reports, putting a future FDA approval in some doubt. Neither CardioMEMS nor St. Jude responded to requests for comment.

The device is an implantable sensor that can measure pulmonary pressure in heart failure patients and wirelessly stream data to physicians, ideally slashing the rates of costly hospital re-admissions. If approved, it would be the first implantable heart failure diagnostic system in the U.S., and analysts have pegged the global market for such technology at about $2 billion.

Seeing a wealth of promise, St. Jude paid $60 million for a 19% stake in CardioMEMS back in 2010, holding the rights to snatch up the rest of the company for $375 million. Leading up to Wednesday's panel vote, St. Jude was trading at a 52-week high, riding investor optimism that Champion's day would finally come.

In 2011, the same panel rejected the device, with members saying they couldn't determine how effective it was because CardioMEMS investigators were too heavy-handed in the study, deploying company nurses to advise physicians on how to deal with patients in the treatment group, possibly skewing the results. A year later, the FDA sent CardioMEMS a non-approvable letter, tasking the company with doing a new analysis of the data while excluding the offending input.

In the latest meeting, many panel members remained unconvinced by the device's effectiveness data, with some saying the device's low risk profile made it worth a chance and others suggesting CardioMEMS start over and kick off a new randomized clinical trial.

How the FDA will act on their opinions remains to be seen. The agency is not obligated to follow the will of its advisers, and while it usually does, CardioMEMS' split vote makes for a tough call.

- read the Healio story

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