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New Device Approval

Illustration of device.Vitagel™ Surgical Hemostat - P050044

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Vitagel™ Surgical Hemostat
PMA Applicant: Orthovita, Inc.
Address: 45 Great Valley Parkway; Malvern, PA 19355
Approval Date: June 16, 2006
Approval Letter: http://www.fda.gov/cdrh/pdf5/p050044a.pdf

What is it? Vitagel™ Surgical Hemostat (Vitagel) is a product that assists the body in clotting blood. After Vitagel has performed its function, it is absorbed by the body. Vitagel includes the biological component thrombin, an enzyme that assists in the clotting of blood. Vitagel is intended to assist in clotting when conventional means fail or are impractical.

How does it work? The primary mode of clotting for Vitagel is the formation of a protein (collagen/fibrin) clot that serves as a physical barrier to blood flow. The thrombin component helps form a clot by converting the protein fibrinogen to fibrin during clotting.

When is it used? Vitagel is used during surgical procedures (except neurosurgery and eye surgery) as an adjunct to clotting when control of bleeding using suture or other conventional procedures is not effective, or seems impractical.

What will it accomplish? Vitagel was shown to be effective in controlling bleeding in hepatic, general, cardiac and orthopedic surgical procedures. The most common adverse events observed in the treated patients were fever, pain, nausea and collapse of a lung (atelectasis).

When should it not be used? Vitagel should not be injected into blood vessels or be used in surgical situations where it may enter a blood vessel as it could cause a clot to form in a blood vessel causing serious damage and death. Vitagel should not be used in patients with who are allergic to materials of cow (bovine) origin.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf5/p050044.html

Updated June 21, 2006

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