FDA Approves Collagen Facility – Highly Purified Collagen Used With Surgical Procedures To Control Bleeding

Collagen is in big demand today and having the factory FDA approved will also lead to the development of other collagen products. BD

Orthovita, an orthobiologics and biosurgery medical device company, has received FDA approval for the company's PMA supplement of a new collagen, Vitagel processing facility in Malvern, Pennsylvania.

Orthovita expects to use the new facility to process the highly purified form of collagen used in its Vitagel Surgical Hemostat product. Vitagel is a composite liquid hemostat used in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Vitagel is combined with the patient’s own plasma immediately prior to application to a bleeding site. A fibrin/collagen clot forms quickly to control bleeding and provide a three-dimensional matrix to facilitate healing.