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FDA faults Sanuwave PMA application. Hill-Rom buys Volker. St. Jude on-track for 2012 European debut of Portico transcatheter valve. More news briefs.

FDA wants Sanuwave Health Inc.to conduct a new clinical trial of its acoustic pressure wave-based dermaPace device for treatment for diabetic foot ulcers, according to a “major deficiency letter” from the agency regarding the ongoing review of the firm’s PMA application, the company says. Announced Dec. 21, the letter cited, among other deficiencies, the dermaPace study’s previously disclosed failure to meet its primary endpoint of 100% wound closure compared with sham-control at 12 weeks. Among the letter’s recommendations to address the deficiency “is for Sanuwave to design and conduct another clinical trial using the findings from any subgroup(s) that may support the safety and effectiveness of the dermaPace device,” the company says.

The firm notes that its study endpoint of complete closure of diabetic foot ulcer wounds reached statistical significance at 20 weeks, and this information was included in its PMA submission....

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