UPDATE: CardioMEMS CEO on FDA's Champion ruling

December 9, 2011 by MassDevice staff

An FDA advisory panel fails to confirm that the benefits outweigh the risks of a CardioMEMS implantable heart pressure monitor, casting a shadow on St. Jude Medical's potential $375 million buyout.


UPDATED Dec. 9, 2011, with comments from CardioMEMS CEO Dr. Jay Yadav, trial results

An FDA advisory panel decided that CardioMEMS failed to prove that its wireless, implantable heart monitor's benefits outweigh its risks, casting a shadow on a potential $375 million acquisition by St. Jude Medical (NYSE:STJ) – which already owns nearly a fifth of CardioMEMS.

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 panel voted 9-1 that the device is safe, but decided that the trial failed to prove its effectiveness on a 7-3 vote. The committee voted 4-6 that the benefits of the device, which measures pulmonary artery pressure, have been proven to outweigh its risks.

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"Everybody believes something good happened here, but we can't say why," said panel chairman Dr. Jeffrey Borer, according to Reuters.

"We can't tell you the device was critically important" to the study's results, Borer added, according to heartwire. The trial showed fewer hospitalizations for patients whose treatment was guided by reading from the device.