A Food and Drug Administration advisory panel voted against approving CardioMems' wireless, permanently implantable device that would allow cardiologists to remotely monitor heart-failure patients.
FDA panel votes against approving wireless heart monitor
Panel members voted 9-1 that the device is safe but concluded that they could not determine whether the device is effective, according to a news release from Atlanta-based CardioMems. They also concluded that reasonable assurance of the risks associated with the technology outweighed the potential benefits.
In addition, the FDA expressed concern in an addendum to its executive summary (PDF) of the decision that the "conduct of the clinical trial may have biased the study results." The panel said there was evidence that the sponsor or the principal investigators contacted investigational sites and made therapeutic recommendations for some subjects in the treatment group.
"FDA is concerned that the heart-failure recommendations by the sponsor and national (principal investigators) for individual study subjects in the treatment (investigational) arm only may bias the study results because these efforts may minimize hospitalization for treatment group subjects without a comparable effort for control group subjects," the panel said.
CardioMems submitted the premarket approval application for the Champion Heart Failure Monitoring System in April.
Last year, St. Jude Medical invested $60 million in CardioMems and signed an agreement that would provide the St. Paul, Minn.-based global devicemaker with the exclusive option to acquire the company for an additional $375 million.
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