Medtronic InSync ICD Panel Review Anticipated, SCD-HeFT Payoff Awaited
This article was originally published in The Gray Sheet
Medtronic expects its InSync ICD combination resynchronization/ICD premarket approval application to go before FDA's Circulatory System Devices Panel in March 2002
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Medtronic will be allowed to use patients enrolled in the trials of its next-generation InSync III to partially fulfill a 1,000-patient, post-approval study requirement for the current generation InSync biventricular pacing system for congestive heart failure, FDA says.
The Circulatory System Devices Panel's approvable recommendation for Medtronic's InSync pacing system sets the stage for FDA final sign-off by Sept. 30, the last day of the federal fiscal year.
Positive results from two ongoing clinical trials currently examining implantable cardioverter defibrillators (ICDs) in preventing sudden cardiac death could lead to "a tremendous increase in prophylactic use," Gust Bardy, MD, University of Washington, Seattle predicted May 17.