FDA approval for small vessel cobalt chromium coronary stent

Sep 20 2004

Guidant Corporation has announced U.S. Food and Drug Administration (FDA) approval of the company’s newest stent system designed to treat coronary artery disease in small vessels in patients with abrupt or threatened abrupt closure.

The cobalt chromium technology of the Coronary Stent System provides physicians the thinnest-strut small vessel stent on the market for excellent acute and long-term patient outcomes.

“The MULTI-LINK MINI VISION demonstrates Guidant’s leadership in developing innovative technology for treating patients with heart disease,” said Dr. David Cox of Mid Carolina Cardiology, Charlotte, North Carolina, the principal investigator for the MULTI-LINK MINI VISION patient registry. “Guidant’s pioneering use of cobalt chromium gives the MULTI-LINK MINI VISION flexibility and deliverability to meet the unique challenges of small vessel stenting.”

“The MULTI-LINK MINI VISION Coronary Stent System is a highly deliverable device that has performed extremely well in Europe since its introduction earlier this year,” said Dana G. Mead, Jr., president, Vascular Intervention, Guidant Corporation. “Our proprietary cobalt chromium technology provides significant value to physicians, and this approval will build upon our worldwide market-leading position in metallic stents and strengthen our position in the U.S. small vessel segment.”

Small vessels are defined as those with diameters of less than 2.5 mm; approximately 25 percent of plaque lesions occur in such vessels. With the introduction of this new stent system, Guidant’s cobalt chromium stents are now available in a full range of sizes in the United States. The MULTI-LINK MINI VISION Coronary Stent System is indicated for patients with small vessels at risk of sudden closure.