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.
“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.
The panel flagged recommendations that CardioMEMS nurses gave to the physicians conducting the trial, including emails and phone calls, recommending treatment options for the patients carrying the device.
"While we are disappointed with today’s outcome, we look forward to continuing discussions with the FDA to determine the best path forward. We believe this technology is a significant step forward in the management of heart failure patients," CardioMEMS CEO and founder Dr. Jay Yadav said in prepared remarks.
St. Jude dropped $60 million on a 19 percent stake in Atlanta-based CardioMEMS in September 2010. The deal contained an exclusive $375 million buyout clause, an option STJ might be reconsidering after the panel’s call.
Or maybe not, based on the trials strong showing in the efficacy department, as measured by its primary endpoint of heart failure hospitalizations. Patients in CardioMEMS’ Champion trial showed a 28% reduction in hospitalizations after 6 months and a 37% reduction at 15 months, according to CardioMEMS. The trial also met its endpoints for safety and secondary efficacy, the company said.
FDA advisory panel votes aren’t binding on the agency, but it often follows their lead in deciding whether to approve or clear a medical device for the U.S. market.