Vascular solutions has received conditional approval from the FDA in the form of an investigational device exemption (IDE) for its clinical study to support the use of Thrombin-VSI in its hemostatic devices, the firm has reported.
The study will evaluate the performance of Thrombin-VSI in comparison to Vascular Solutions' original source of thrombin in use with its diagnostic Duett Pro sealing device, the company said.
The clinical study should satisfy the clinical requirements qualifying the use of Thrombin-VSI in the its D-Stat Dry, D-Stat Radial, hrombiGel and D-Stat Flowable hemostats, the firm added.
To view the company's announcement, go to http://www.vascularsolutions.com/investor/press.php (http://www.vascularsolutions.com/investor/press.php).