FDA gives conditional approval to Vascular Solutions for thrombin study

By Lisa Kerner

Charlotte, N.C., June 20 - The Food and Drug Administration granted conditional approval to Vascular Solutions, Inc.'s Investigational Device Exemption, allowing the company to begin a clinical study of its Thrombin-VSI.

The study will compare Thrombin-VSI to the company's original source of thrombin used with its Diagnostic Duett Pro sealing device.

In addition, Vascular Solutions expects the study to satisfy the clinical requirements for using Thrombin-VSI in its D-Stat Dry, D-Stat Radial, ThrombiGel and D-Stat Flowable hemostats.

"This conditional approval is an important milestone in the qualification of our new source of thrombin to control our long-term supply and cost for our hemostatic devices," chief executive officer Howard Root said in a company news release.

"We expect to work with the FDA to quickly resolve the conditions of approval, which include clarification of follow-up tests and the refinement of the randomization between study groups, none of which we expect to delay our commencement of the study."

Vascular Solutions is a medical device company located in Minneapolis.

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