New Guidant Coronary Stent Gets CE Mark

Indianapolis-based Guidant Corp. has received CE Mark approval of its Multi-Link Tetra coronary stent system. The device is based on the original ACS Multi-Link stent, which was launched in the United States in October of 1997.

Guidant studied the Multi-Link Tetra's safety and effectiveness by registering 202 patients at more than 16 sites throughout the United States and Europe.

"This revolutionary new stent design provides enhanced flexibility, deliverability and surface area coverage while maintaining radial strength," said Dean Kereiakes of Christ Hospital in Cincinnati, who is the principal investigator for Guidant's Multi-Link Tetra registry. "The Multi-Link Tetra is the new benchmark for coronary stenting."

The stent is indicated for use in de novo (first-time) blockages in native coronary arteries and also for saphenous vein grafts used in coronary artery bypass graft surgery. Sizes include 2.5, 2.75, 3.0, 3.5, and 4.0 mm diameters and 8, 13, 18, 23, 28, 33, and 38 mm lengths.

A subset of the clinical data from the registry was submitted to the U.S. Food and Drug Administration in April of this year. Guidant anticipates FDA approval this year.

Edited by Ursula Jones