Sep 23, 2002
Guidant Introduces Innovative New Device for Coronary Bypass Graft Procedures

New Technology May Reduce Risk of Major Complications

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiac and vascular disease, today announced the company has received CE Mark and FDA 510k clearance for its HEARTSTRING(tm) Proximal Seal System. The device provides surgeons with the ability to perform conventional and beating-heart Coronary Artery Bypass Graft (CABG) surgery without using a side-biting clamp on a patient''s aorta, potentially reducing the risk of major cardiac and neurologic complications.

"The HEARTSTRING System''s potential to decrease the risk of major complications in traditional and beating-heart bypass procedures makes this an important addition to the portfolio of innovative products Guidant provides cardiac surgeons, and another step forward in the transformation of cardiac surgery," said Nicky Spaulding, president, Cardiac Surgery, Guidant Corporation. "Guidant is committed to bringing the most innovative cardiac surgery technologies to patients and physicians worldwide."

Approximately 375,000 CABG procedures are performed each year in the U.S., of which approximately 25 percent are currently estimated to be completed utilizing the beating heart approach. Traditional CABG surgery requires surgeons to stop the patient's heart and artificially replace its blood-pumping and oxygen-providing functions by using a heart-lung machine. Beating heart CABG is performed while the heart continues to beat, eliminating the use of the heart-lung machine. During the bypass procedure, healthy arteries or veins are harvested to create bypass grafts that channel the needed blood flow around the blocked portions of diseased coronary arteries. The arteries or veins are connected from the aorta to the surface of the heart beyond the blockages forming a graft. This promotes blood flow and bypasses the narrowed or closed points.

Proximal anastomosis, the connecting of graft vessels to the aorta, is one of the most challenging aspects of the CABG procedure. In order to prevent blood loss during the proximal anastomosis, surgeons have traditionally applied a metal side-biting clamp to the aorta, a practice that has been associated with intra- and postoperative complications.

The HEARTSTRING Proximal Seal System was first used in a beating-heart bypass graft procedure performed by Dr. Federico Benetti in Europe. "The HEARTSTRING Proximal Seal System allows physicians to perform a completely clampless beating-heart bypass graft without significantly altering traditional surgical techniques. The HEARTSTRING is an innovative yet uncomplicated device that I believe will lead to better outcomes for patients," said Dr. Benetti.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 10,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life''s most threatening medical conditions. For more information visit www.guidant.com.