Vascular Architects Receives Clearance to Market Its Next Generation aSpire Covered Stent System in the U.S.

Business Editors/Health/Medical Writers

SAN JOSE, Calif.--(BUSINESS WIRE)--Sept. 8, 2003

New Lower Profile Delivery System Now Compatible

with 7F Introducer Sheath

Vascular Architects, Inc., today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market the next generation Vascular Architects aSpire(R) Covered Stent and 718(TM) Delivery System in the U.S. The device is cleared for use in treating tracheobronchial strictures.

The aSpire Covered Stent and 718 Delivery System utilizes Vascular Architects' innovative spiral stent implant while offering significant enhancements to the delivery system. The new delivery system is now compatible with a 7 French introducer sheath.

The aSpire Covered Stent provides significantly greater lumen wall coverage than conventional metal stents, due to its spiral nitinol design which is covered with a thin layer of ePTFE, protecting the lumen from exposed metal. Unlike other covered stent grafts, the aSpire Covered Stent's spiral design delivers exceptional radial strength while preserving many of the native lumen's desired elements. The new 718(TM) Delivery System separates stent apposition and deployment into two distinct steps, enabling precise deployment in a 7 French compatible system.

"The new aSpire Covered Stent and 718 Delivery System maintains all the benefits of the prior generation device, while incorporating several improvements to make it even easier to use," explained Bruce Barclay, President and CEO of Vascular Architects. "The stent's unique spiral configuration still provides exceptional radial strength, flexibility and coverage, while the new 718 Delivery System now enables the stent to be precisely delivered and deployed through a 7 French sheath." He added, "The 718 Delivery System gives physicians control, enabling them to visually confirm the stent's location and, if necessary, reposition and appose it again prior to deployment. Combining the benefits of the existing stent implant along with the enhancements to the delivery system, the new aSpire Covered Stent and 718 Delivery System will offer physicians and their patients the potential for better overall treatment." The Vascular Architects aSpire Covered Stent and 718 Delivery System is available for immediate delivery in the United States.

Vascular Architects develops, manufactures and markets devices for treating peripheral vascular disease and nonvascular obstructions. The company was founded by Dr. Thomas J. Fogarty, a noted cardiovascular surgeon, inventor and entrepreneur. The aSpire Covered Stent and Controlled Expansion Delivery System has received its CE mark in Europe for treating peripheral vascular disease. The company also markets the MollRing Cutter(R) in the U.S. and Europe for the minimally invasive treatment of iliac and SFA vascular occlusive disease by a procedure known as remote endarterectomy. Vascular Architects is privately held with investors that include Medtronic, Johnson and Johnson Development Corporation and Edwards Lifesciences.