AngelMed Cardiac Monitor Panned At FDA Panel Over Clinical Trial Concerns

An FDA advisory panel recommended against approval of the AngelMed Guardian System, an implant that watches electrical heart signals and sounds an alarm for early detection of ischemic events. The panelists couldn’t get past trial flaws, including failure to meet the primary endpoint and early cessation of patient enrollment.

Trial shortfalls – including the early termination of patient enrollment and failure to meet an efficacy endpoint – sank Angel Medical Systems Inc.'s implantable cardiac monitor at an FDA Circulatory System Devices advisory panel meeting.

The 12-member panel unanimously voted that the evidence presented by the company for its AngelMed Guardian System did not show...

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