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InterVentional Technologies presents early Cutting Balloon clinical data to panel.

SAN DIEGO--(BUSINESS WIRE)--March 8, 1996--InterVentional Technologies Inc., Friday announced that its application to the U.S. FDA for an early conditional approval for its Cutting Balloon as a conventional PTCA catheter was not approved by the Circulatory System Devices Panel which met on March 4.

The FDA had worked very closely with the company in preparing the company's ``Panel Package'' for this review, but the Panel concluded that an approval at this time was premature. It advised the company to complete its ongoing Global Randomized Trial and at that time to resubmit the larger data base for review.

The Panel also made suggestions to both the company and the FDA on changes that might be considered in the ongoing clinical trial to facilitate completion of the study at the earliest. The company will implement these changes pending FDA agreement.

The Cutting Balloon, more properly known as the Barath Microsurgical Dilatation Balloon, incorporates tiny blades longitudinally situated on an angioplasty balloon. The product has been approved in Europe, Canada and Japan, and the worldwide experience of Cutting Balloon use exceeds 6,000 cases.

At the recent Transcatheter Cardiovascular Therapeutics Meeting, a number of Japanese and Canadian physicians reported lower restenosis rates with this product as compared with standard angioplasty.

The company chairman and chief executive officer, Robert E. Reiss, stated, ``While we are disappointed the Panel did not recommend the early conditional approval we sought, we intend to abide by the Panel's suggestion to complete the current clinical trial as fast as possible in order to bring the benefits of this new technology to U.S. patients at the earliest.

``We thank the FDA for helping us in our endeavors and for giving us an opportunity to bring our request to their Advisory Panel for consideration, review and guidance.''

InterVentional Technologies develops, manufactures and markets microsurgical devices for the treatment of cardiovascular disease. Besides pursuing the Cutting Balloon project, the company currently markets its TEC Thrombectomy System in the United States, and is in the advanced research stage on two new technology platforms: the INFILTRATOR Intra-arterial Wall Drug Delivery System and the Segal Perfusion Dilatation Catheter System. The company is privately held and venture capital funded.

CONTACT: InterVentional Technologies Inc., San Diego

Rob Michiels, 619/268-4488, ext. 3050
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Publication:Business Wire
Date:Mar 8, 1996
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