This article was originally published in The Gray Sheet
Lithotripter premarket approval application submission to FDA covers treatment of plantar fasciitis (heel spurs). The filing had been delayed pending feedback from the agency on clinical trial results (1"The Gray Sheet," Sept. 6, p. 18). The 30-month, multi-site, double-blind study included over 300 patients. The Marietta, Georgia company also is pursuing additional orthopedic applications, including lateral epicondylitis (tennis elbow) and non-union fractures, for which ongoing studies will be expanded in early 2000
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A premarket approval application for HealthTronics' OssaTron lithotripter for treatment of chronic heel pain due to planar fasciitis should be submitted to FDA by December.
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