Sep 8, 2000
Guidant Announces FDA Approval of its MULTI-LINK ULTRA Coronary Stent System for Large Coronary Arteries

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced that it has received U.S. Food and Drug Administration approval to market its MULTI-LINK ULTRA(tm) Coronary Stent System. As evidence of Guidant''s novel product development capabilities, the MULTI-LINK ULTRA is Guidant''s first coronary stent that is specifically designed for the treatment of larger native coronary arteries - those with diameters from 3.5 to 5.0 mm.

"The MULTI-LINK ULTRA Coronary Stent System represents another important milestone for Guidant in the treatment of coronary artery disease," said John M. Capek, Ph.D., president of Guidant's Vascular Intervention Group. "The MULTI-LINK ULTRA''s ability to effectively treat large vessels will allow physicians to treat patients with coronary blockages in a minimally invasive manner. This stent is the first in a series of Guidant stent systems currently in development and clinical evaluation that are designed to treat coronary blockages in specific locations."

Based on the original Guidant MULTI-LINK stent design, the MULTI-LINK ULTRA features attributes appropriate for the unique aspects of lesions found in larger vessels. This stent has the ability to cover a large surface area of atherosclerotic plaque found in large diameter vessels. Like Guidant''s other stents, the MULTI-LINK ULTRA is designed to be flexible enough to conform to the natural curvatures of the vessel in which it is implanted. In addition, it maintains the radial strength needed to hold open the previously occluded artery. The MULTI-LINK ULTRA offers the visibility physicians need to accurately place the stent at the site of the lesion.

"There is a significant need for a stent that addresses this clinical challenge," said John Douglas, M.D., of Emory University in Atlanta, who served as the principal investigator for Guidant''s MULTI-LINK ULTRA registry. "Guidant''s MULTI-LINK ULTRA Stent addresses many of the procedural challenges faced by physicians treating patients with coronary artery disease in larger vessels."

The MULTI-LINK ULTRA Coronary Stent System is indicated for use in de novo (first-time) and restenotic (re-occurring) lesions in native coronary arteries, as well as for abrupt or threatened abrupt closure. Sizes include 3.5, 4.0, 4.5 and 5.0 mm diameters and 13, 18, 28 and 38 mm lengths; the 38 mm length is indicated solely for use in patients with abrupt or threatened abrupt closure. Guidant has conducted a clinical study for use of this product in saphenous vein grafts. Saphenous vein grafts are used in coronary artery bypass surgery to create a detour around the blocked portion of the native coronary artery. Guidant anticipates filing with the FDA for an indication for saphenous vein grafts in the near future. The MULTI-LINK ULTRA is currently approved for use in native coronary arteries and saphenous vein grafts in Europe and in other countries that base regulatory approval for medical devices on the European CE Mark.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.