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WGT Gains EMI Filtering Technology For OEM Sales Through Maxwell’s Sierra

This article was originally published in The Gray Sheet

Executive Summary

Wilson Greatbatch Technologies is adding electromagnetic interference (EMI) filtering technology to its implantable device component supply business through the acquisition of Maxwell Technologies' Sierra medical electronics unit

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Use of rhBMP-2 bone morphogenic protein product for long-bone fractures is expected by the firm's Genetics Institute unit to go before FDA's Orthopedics and Rehabilitation Devices Advisory Panel by the end of 2002. The firm received a not-approvable letter for the indication June 22 due to problems with the initial clinical trial design and data interpretation (1"The Gray Sheet" June 25, 2001, p. 27). Stryker's OP-1 will be the first bone morphogenic protein product on the market following humanitarian device exemption clearance for long-bone non-union fractures, announced Oct. 17 (2"The Gray Sheet" Oct. 22, 2001, p. 20). AHP hopes to be on the market in early 2003

American Home Products

Use of rhBMP-2 bone morphogenic protein product for long-bone fractures is expected by the firm's Genetics Institute unit to go before FDA's Orthopedics and Rehabilitation Devices Advisory Panel by the end of 2002. The firm received a not-approvable letter for the indication June 22 due to problems with the initial clinical trial design and data interpretation (1"The Gray Sheet" June 25, 2001, p. 27). Stryker's OP-1 will be the first bone morphogenic protein product on the market following humanitarian device exemption clearance for long-bone non-union fractures, announced Oct. 17 (2"The Gray Sheet" Oct. 22, 2001, p. 20). AHP hopes to be on the market in early 2003

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Sulzer Biologics says it will find a U.S. distribution partner for the Ne-Osteo Spine bone morphogenic protein prior to pursuing FDA approval for use in spinal fusion.

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