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Medical Device Studies for Premarket Approval Assessed

Last Updated: December 29, 2009.

Premarket approval of cardiovascular medical devices based on early-stage studies are typically not statistically powered adequately and may potentially be biased, according to a study in the Dec. 23/30 issue of the Journal of the American Medical Association.

TUESDAY, Dec. 29 (HealthDay News) -- Premarket approval (PMA) of cardiovascular medical devices based on early-stage studies are typically not statistically powered adequately and may potentially be biased, according to a study in the Dec. 23/30 issue of the Journal of the American Medical Association.

Sanket S. Dhruva, M.D., of the University of California in San Francisco, and colleagues performed a systemic review of efficacy and safety data sets for 78 cardiovascular devices that received PMA during January 2000 to December 2007.

The authors note that, of 123 studies, 27 percent were randomized and 14 percent were blinded, and 65 percent of the PMAs were based on one study. In terms of study design, 52 percent of primary end points were compared to controls, with 88 percent using surrogate measures and 78 percent presenting with differences between patients enrolled and those analyzed. In addition, 31 percent of studies included were retrospective.

"This study suggests that the emphasis for the FDA in 2009 and beyond must be approvals based on research that meets rigorous scientific standards for evidence of benefit and lack of harm to patients. To uphold the FDA's mission of 'ensuring safe and effective' medical devices, it is essential that high-quality studies and data are available," the authors write.

One author reported being a member of the FDA Circulatory System Devices Panel and a member of the California Technology Assessment Forum.

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