Datascope Corp. announced that its InterVascular Inc subsidiary has received FDA clearance to market its InterGard Heparin vascular graft.

InterGard Heparin is the first vascular prosthesis incorporating a drug to be cleared by the FDA for U.S. sales. It has been successfully implanted in over 15,000 patients since its introduction in Europe in 1993.

Vascular graft occlusion, due to the development of a blood clot or thrombus, is recognized as the most frequent cause for failure of small caliber vascular prostheses and is associated with a high risk of limb loss. InterGard Heparin is a unique drug/device combination, which has demonstrated clinically significant improved patient outcomes and higher potency rates compared to small caliber grafts, which are made of PTFE material (primarily Teflon).

Based on experience in Europe and other markets throughout the world, InterGard Heparin is expected to compete effectively with PTFE grafts which currently dominate the small caliber market in the U.S. InterGard Heparin is planned to begin shipping in the U.S. during the fourth quarter and will be priced at a premium to competitive grafts.

Datascope Corp. is a diversified medical device company that manufactures and markets proprietary products for clinical health care markets in interventional cardiology and radiology, cardiovascular and vascular surgery, anesthesiology, emergency medicine and critical care.