Jan 29, 2001
Guidant Introduces New Beating Heart Coronary Artery Bypass Platform

Indianapolis, Ind. and Cupertino, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiovascular disease, announced today the introduction of a new product designed to treat patients suffering from coronary artery disease in need of coronary artery bypass surgery. Guidant's new Axius(tm) Off-Pump System is designed for use in beating heart bypass procedures, which allow surgeons to bypass clogged arteries without stopping the patient's heart and re-directing blood flow through a heart-lung machine.

The Axius Off-Pump System is comprised of a low-profile mounting mechanism to securely hold the system components in place during the beating heart bypass procedure, a stabilization platform that steadies areas of the beating heart requiring bypass grafts and an access device designed to lift the heart from the patient's chest and provide access to all areas, including vessels on the back of the heart.

"Guidant's Axius Off-Pump System gives physicians an easy to use system for performing complete revascularization of significantly blocked coronary arteries," said Joseph F. Sabik, III, M.D., of the Cleveland Clinic. "By providing physicians with a reliable and reproducible method of performing coronary artery bypass surgery on a beating heart, we are able to treat a greater number of patients with this minimally invasive therapy." Sabik recently performed the first live case using the Axius Off-Pump System at the Cardiothoracic Techniques and Technologies meeting attended by over 900 participants on Jan. 26 in New Orleans, LA.

A fully integrated, complete system designed to enable multi-vessel coronary revascularization with an off-pump procedure, Guidant's Axius Off-Pump System was developed to provide surgeons superior stabilization and easy access to all areas of the heart without compromising cardiac function. The new Axius Off-Pump System includes the following features:

  • An easy to use, low profile system that allows physicians to easily position target vessels during the beating heart bypass procedure using the Axius XPOSE(tm) device to provide access to the heart

 

  • The ability to access and stabilize all areas of the heart with a system designed to reduce hemodynamic compromise, which lowers the risk of variations in blood pressure during the beating heart bypass procedure

 

  • A choice of stabilization methods, which allows physicians to select either a vacuum or mechanical stabilizer for the area of the beating heart that requires a bypass graft

 

  • A new interlocking link design that is intended to provide the flexibility needed to maneuver and position the system while allowing the stability required to perform the beating heart bypass procedure

Less Invasive Coronary Artery Bypass Procedures Offer Patient Benefits

Beating heart bypass procedures have been shown to provide several benefits to patients. When compared to procedures that require the heart to be stopped, beating heart bypass procedures have been shown to reduce transfusion rates by 48 percent,1 to reduce post-operative cognitive dysfunction by 36 percent at 5 days and 90 percent at 3 months,1 to reduce the length of hospital stay by 40 percent,1 and to decrease hospital costs by 24 percent2.

Coronary artery bypass patients often require another procedure to harvest the greater saphenous vein. Located in the leg, this vein is a commonly used graft in coronary artery bypass procedures. There are two methods to harvest this vein: open saphenous vein harvesting - a procedure that requires a long incision down the length of the patient's leg - and endoscopic vessel harvesting, a less invasive procedure that can be performed through one small incision. When compared to open saphenous vein harvesting techniques, endoscopic vessel harvesting procedures reduced wound complications and wound infections by 75 percent in coronary artery bypass patients.3

OPCRES (Off-Pump Coronary Revascularization with Endoscopic Saphenous vein harvesting) is a new procedure that combines beating heart bypass surgery with endoscopic vessel harvesting.

"The OPCRES procedure offers two distinct benefits to patients requiring treatment with coronary artery bypass surgery," said Nicky Spaulding, President, Guidant Cardiac Surgery Group. "First, it allows patients to receive treatment with beating heart bypass procedures, which may eliminate many potential side effects of traditional bypass surgeries that stop the patient's heart and utilize a heart and lung machine. Second, it enables endoscopic harvesting of the saphenous vein, a treatment method that reduces wound complications when compared to traditional open saphenous vein harvesting procedures. Guidant's new Axius Off-Pump System joins our VasoView® Endoscopic Vessel Harvesting System to form a comprehensive suite of products that enable physicians to perform the less invasive OPCRES procedure."

Guidant's VasoView Endoscopic Vessel Harvesting System can be used in conjunction with the Axius Off-Pump System to perform the OPCRES procedure. The VasoView System is designed to provide physicians with a minimally invasive method to harvest the saphenous vein. This method was developed to reduce scarring and potential risk of infection that may result from traditional saphenous vein harvesting procedures. Endoscopic harvesting with the VasoView System utilizes a small, 2 cm incision in the patient's leg. Traditional harvesting procedures require a long incision in the patient's leg, stretching from the groin to the ankle.

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. For more information on Guidant's products and services, visit the company's web site at www.guidant.com.

1. Puskas JD; Wright CE, Ronson RS; Brown WM; Gott JP; Guyton RA. Clinical Outcomes and Angiographic Patency in 125 Consecutive Off-Pump Coronary Bypass Patients. Heart Surgery Forum 1999; 2(3): 216-221 2. Murkin JM; Boyd WD; Ganapathy S; Adams SJ; Peterson RC; Beating heart surgery: why expect less central nervous system morbidity? Annals of Thoracic Surgery, 1999 Oct, 68(4): 1498-501 3. Bitondo JM & Dagett WM. Endoscopic vs. Open Saphenous Vein Harvest: A Comparison of Post-Operative Wound Complications. Circulation 2000; 102(18 suppl ii): ii-402

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