FDA grants PMA to Orthovita for Vitagel Surgical Hemostat

By Lisa Kerner

Charlotte, N.C., June 16 - The Food and Drug Administration has granted pre-market approval to Orthovita, Inc. for its Vitagel surgical hemostat. The company said it expects to ship and sell the product immediately.

Vitagel is used as an adjunct to hemostasis to control bleeding when conventional procedures are ineffective or impractical, according to a company news release.

Orthovita had been distributing Vitagel and its Cellpaker product through Angiotech BioMaterials Corp.

Located in Malvern, Pa., Orthovita is a biomaterials company that develops synthetic, biologically active tissue engineering products for orthopedic and neurosurgical applications.

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