Mar 16, 2001
Guidant Attains U.S. Coronary Angioplasty Market Leadership, Reinforcing its Position as the Global Leader in Interventional Cardiology

Company Announces Worldwide Approval of POWERSAIL and HIGHSAIL Coronary Dilatation Catheters

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT) a world leader in the treatment of coronary artery disease, today announced U.S. approval of its POWERSAIL(tm) and HIGHSAIL(tm) Coronary Dilatation Catheters designed to treat blocked coronary arteries, thus completing the approval process in key markets worldwide. The U.S. Food and Drug Administration (FDA), European CE Mark and Japan's Ministry of Health and Labor Welfare approvals make the products available worldwide. POWERSAIL is on the rapid exchange platform, while HIGHSAIL is an over-the-wire device.

With the introduction of the POWERSAIL and HIGHSAIL Coronary Dilatation Catheters, Guidant now offers a complete family of dilatation catheters for a spectrum of clinical needs. The POWERSAIL and HIGHSAIL complement the CROSSSAIL(tm) and OPENSAIL(tm) Coronary Dilatation Catheters, which both received approval in June 2000. Guidant also makes the lowest profile dilatation catheter on the market today.

Over the last year, Guidant has become the U.S. leader in the $260 million coronary dilatation catheter market. Data from the fourth quarter of 2000 from Guidant's independent market share tracking sources indicates that Guidant holds a 41 percent share of the coronary dilatation catheter market in the U.S., compared to the fourth quarter of 1999 when Guidant held a 34 percent share. Over the same period, Guidant's sales increased 21 percent.

"CROSSSAIL and OPENSAIL have propelled Guidant to the number one market share position in the coronary dilatation catheter market," said John M. Capek, Ph.D., president, Vascular Intervention. "Now, with the worldwide approval of POWERSAIL and HIGHSAIL, we are confident that our comprehensive portfolio will allow us to further advance our leadership position in this highly competitive market. Guidant's leadership position in dilatation catheters complements our existing number one standing in both stents and guide wires, making Guidant the premier company worldwide in vascular intervention."

"The introduction of the POWERSAIL and HIGHSAIL to Guidant's existing line of coronary dilatation catheters provides physicians with an excellent solution for treating complex, highly stenotic lesions and the ability to post-dilate following a stenting procedure," said Ezio Bramucci, M.D., of S. Matteo University of Pavia, Italy. "These new dilatation catheters also provide physicians with the ability to employ a variety of clinical treatment strategies in patients suffering from coronary artery disease."

The POWERSAIL and HIGHSAIL Coronary Dilatation Catheters were developed to open blocked coronary vessels during percutaneous transluminal coronary angioplasty (PTCA) and are indicated for use in native coronary vessels and vein grafts. The hallmark of POWERSAIL and HIGHSAIL is an advanced balloon technology called PLATEAU(tm), which will allow physicians to treat harder, stenotic lesions. With PLATEAU, the balloon maintains its size at higher pressure, and has the capability to refold and dilate repeatedly.

The POWERSAIL Coronary Dilatation Catheter employs a rapid-exchange design that combines into one system a guide wire for maneuvering through a patient's vasculature with an angioplasty balloon for expanding blocked arteries, allowing physicians to utilize the single operator technique for its ease of use and faster procedure time.

Its over-the-wire counterpart, the HIGHSAIL Coronary Dilatation Catheter, allows physicians to use a more familiar technique for the same procedure.

POWERSAIL and HIGHSAIL Coronary Dilatation Catheters are each available in 64 sizes, including two sizes for the treatment of larger diameter vessels (4.5 and 5.0 mm). The POWERSAIL and HIGHSAIL Coronary Dilatation Catheters are approved for the post-stent dilatation indication for use with Guidant's new MULTI-LINK TETRA(tm) and MULTI-LINK ULTRA(tm) Coronary Stent Systems, as well as Guidant's ACS MULTI-LINK®, ACS MULTI-LINK DUET® and MULTI-LINK TRISTAR(tm) Coronary Stent Systems.

A global leader in the medical technology industry, Guidant provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.