Article preview from "The Gray Sheet"- December 12, 2011
The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.
CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings
Article preview from "The Gray Sheet"- December 12, 2011
An FDA panel meeting last week on CardioMEMS Inc.’s PMA for its Champion implantable heart failure monitor was dominated not by the firm’s clinical data but by findings from FDA’s pre-market clinical-site inspections pointing to bias in that data.
The result: CardioMEMS appears to be facing an uphill battle at best for approval. That is a disappointing surprise not only for Atlanta-based CardioMEMS, but also for St. Jude Medical, which holds a 19% ownership stake in the firm and has touted the technology as a major opportunity for its business.
FDA’s Circulatory System Devices panel voted 6-4 that the benefits of Champion do not outweigh its risk at the Dec. 8 meeting in Gaithersburg, Md.
And in spite of the fact that the trial met its primary endpoint of reducing heart-failure hospitalizations, panel members voted 3-7 against device effectiveness due largely to a level of interaction between the sponsor and clinical site investigators that FDA said went beyond the protocol outlined in the firm’s PMA submission.
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