Vascular Solutions Inc has received approval from the U.S. FDA of its Investigational Device Exemption to commence the D-Stat to Prevent Hematoma Formation in Prepectoral Pockets (the "Pocket Protector") clinical study. The Pocket Protector clinical study will investigate the use of the company's D-Stat flowable hemostat to reduce the incidence of bleeding complications in the prepectoral pocket created during implantation of pacemakers and implantable cardioverter defibrillators.

Dr. Theofanie Mela, Director of the Pacing and ICD Lab at Massachusetts General Hospital, one of the institutions where the D-Stat will be tested, commented on the clinical indication being studied: "Presently, there are no approved products available to achieve hemostasis in the prepectoral pocket during implantation of a pacemaker or ICD. Of particular concern are anticoagulated patients, who often develop pocket hematomas and bleeding complications following these procedures. This makes it especially exciting to participate in this innovative clinical trial, as this product has the potential to improve patient comfort, reduce complications associated with hematoma formation, and decrease hospital stays resultant of subsequent hematoma evacuation. If this trial is successful, physicians may see not only an increase in the level of patient satisfaction but also reduced costs for hospitalization resulting from extended stays for the treatment of complications."

Howard Root, CEO of Vascular Solutions, Inc. stated: "We are excited to start this first clinical study of the D-Stat to expand its indications beyond the current topical uses. With over one million pacemaker and defibrillator implants annually worldwide, the market potential for our D-Stat in this area is substantial. We expect to complete this Pocket Protector clinical study this year, with a successful completion leading to a market release for this new indication in 2004."