Guidant Press Releases
May 15, 2000
Guidant Launches its Fourth-Generation Coronary Stent System
MULTI-LINK TETRA Coronary Stent System Receives CE Mark Approval
Indianapolis, IN and Santa Clara, CA - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced CE Mark approval of its MULTI-LINK TETRA(tm) Coronary Stent System, which is now available for commercial use in most European countries and in others that base regulatory clearance on the European CE mark. This innovative system combines all of the best attributes of Guidant''s previous and current market-leading stents and incorporates new technologies to provide physicians with excellent deliverability and implant performance. Based on the clinically proven and highly successful ACS MULTI-LINK® Coronary Stent design, the MULTI-LINK TETRA is Guidant''s fourth-generation coronary stent system.
"This revolutionary new stent design provides enhanced flexibility, deliverability and surface area coverage while maintaining radial strength," said Dr. 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 MULTI-LINK TETRA System incorporates a variety of Guidant-developed technologies that are designed to further enhance deliverability, deployment and performance of the stent. These technical advances include:
- A proprietary new variable-thickness strut technology, which improves deliverability by providing enhanced stent flexibility. This technology also improves performance of the stent by providing an optimal combination of scaffolding, conformability and visibility. While competitive stents may compromise between flexibility, visibility and scaffolding, Guidant''s variable-thickness strut technology provides all three qualities in one stent design. Improving the deliverability and implant performance of the stent enables physicians to have more treatment options.
- A new, flexible catheter tip, which improves tracking, lesion crossing and stent re-crossing.
- A transitional-edge balloon technology, which enables uniform stent expansion during deployment and implantation and minimizes the amount of vessel dilated outside the stent.
- Guidant''s proprietary coating that reduces friction to allow easy passage for negotiating tortuous anatomy.
- A stent crimping technology, which provides excellent stent retention and provides smooth surface transition across the stent and delivery system.
Guidant studied the MULTI-LINK TETRA''s safety and effectiveness by conducting the MULTI-LINK TETRA registry with 202 patients at more than 16 sites throughout the U.S. and Europe. 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 launching the MULTI-LINK TETRA within the U.S. - upon approval by the FDA - during this year.
The MULTI-LINK TETRA implant, like its predecessors - the ACS MULTI-LINK DUET(tm) and ACS MULTI-LINK TRISTAR(tm) Coronary Stent Systems - is based on the original ACS MULTI-LINK® stent, which was launched in the U.S. in October of 1997. Since that time, more than 1.2 million Guidant stents have been implanted worldwide and Guidant has maintained its position as the world-market-leader in coronary stents, outselling competitive devices worldwide in nine of the past ten quarters.
"The MULTI-LINK TETRA Coronary Stent System is the result of the combined experience of more than 1.2 million Guidant stent implants," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group. "We''ve responded to feedback from our physician customers by incorporating the best attributes of our previous stent systems. Those features, along with several new technologies have been developed into a system that we believe provides a significantly improved level of clinical performance that will enable interventional cardiologists to treat a greater number of patients suffering from coronary artery disease."
The MULTI-LINK TETRA System 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 global leader in the medical device industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease. For more information about Guidant''s products and services, visit the company''s Web site at http://www.guidant.com.