Sep 28, 2004
Guidant Reports Positive Six-Month Results from the SPIRIT FIRST Everolimus Eluting Coronary Stent Trial

Results Demonstrate the Benefit of An Everolimus Eluting Coronary Stent with Durable Polymer; Investor Briefing Scheduled for 8:00 a.m. ET Tomorrow

Indianapolis, Ind., and Washington, D.C. - Guidant Corporation (NYSE: GDT) today announced positive six-month adjudicated results from the company''s 60-patient SPIRIT FIRST study. SPIRIT FIRST is a prospective, randomized, single-blind trial evaluating Guidant''s MULTI-LINK VISION®-based everolimus eluting coronary stent system utilizing a durable polymer versus an uncoated MULTI-LINK VISION Coronary Stent System control in de novo (previously untreated) lesions.

Angiographic in-stent late loss at six months, the study''s primary endpoint, was 0.10 mm for the MULTI-LINK VISION-based everolimus eluting stent system and 0.84 mm for the control arm. The in-stent angiographic binary restenosis rate for the everolimus eluting stent arm was 0 percent. The six-month MACE rate for the everolimus eluting stent was 7.7 percent, and there were no new MACE events between 30 days and six months. As defined in SPIRIT FIRST, the MACE rate includes any deaths, heart attacks or clinically driven target lesion revascularizations within the six-month period. These results are consistent with the outstanding results from the FUTURE I and FUTURE II clinical trials utilizing a stainless steel stent platform with everolimus and a bioabsorbable polymer. Additional angiographic, intravascular ultrasound and clinical data will be presented after the completion of one year of follow-up.

"These impressive results demonstrate the effectiveness of Guidant''s cobalt chromium everolimus eluting stent with a durable polymer," said Prof. Patrick W. Serruys, M.D., of the Thoraxcenter, Erasmus University Hospital, Rotterdam, who serves as the study''s principal investigator. "I believe this highly deliverable cobalt chromium drug eluting stent will be an extremely competitive product when introduced to the marketplace."

"Everolimus has clearly proven its effectiveness in reducing tissue proliferation in the coronary vessels following stent implantation, first in the FUTURE trials and now in SPIRIT FIRST. We are excited about combining this unique drug and polymer with the MULTI-LINK VISION, our most advanced coronary stent system," said Dana G. Mead, Jr., president, Vascular Intervention, Guidant. "We look forward to leveraging these positive results as we move forward with additional regulatory filings and clinical studies, including a U.S. pivotal trial scheduled to commence in the first quarter of 2005."

Data Presentations Today at TCT

Full SPIRIT FIRST results will be presented by Prof. Serruys today at 2:48 p.m. in Room 151 AB at the Cardiovascular Research Foundation''s (CRF) Sixteenth Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2004) in Washington, D.C. The slides from Dr. Serruys'' discussion will be made available on the Guidant Web site at www.guidant.com/investors/ in connection with his presentation. The results will also be shared at a TCT evening symposium sponsored by Guidant at 8:00 p.m. at the Renaissance Washington in the Grand Ballroom.

Investor Briefing Scheduled for Tomorrow Morning

Guido J. Neels, chief operating officer, Guidant Corporation, will host an investor briefing tomorrow, Wednesday, September 29, from 8:00 to 9:00 a.m. ET. During the briefing, Prof. Serruys will discuss the results of the SPIRIT FIRST clinical trial. Dana G. Mead, Jr., will also provide an update on Guidant''s drug eluting stent programs.

The investor briefing will be webcast live and will be accessible through Guidant''s Web site at www.guidant.com/webcast. The webcast will be archived for future on-demand replay.

About Guidant''s Drug Eluting Stent Program

Guidant has been a global innovator in stent technology since 1995, when its first coronary stent for the treatment of heart disease was launched internationally. Since then, the company has consistently been the market leader in metallic stent sales worldwide. Guidant''s drug eluting stent program leverages this market-leading position as well as the company''s excellent customer relationships built through its world-class sales force. The company''s vascular intervention business is focused on developing broad capabilities in drug eluting stents, including product design, clinical science, polymer science and product commercialization. Guidant holds a worldwide exclusive license from Novartis Pharma AG to use everolimus, a novel proliferation-signal inhibitor with potent anti-proliferative and immunosuppressant properties, in drug eluting stents. Guidant has both durable and bioabsorbable polymer drug carriers in development, providing product design flexibility and potentially offering unique clinical benefits.

Guidant gained immediate entry into the U.S. drug eluting stent market in February 2004 through an agreement with Cordis Corporation, a Johnson & Johnson company. Under the terms of the agreement, Guidant co-promotes Cordis'' CYPHER(tm) Sirolimus-eluting Coronary Stent in the United States.

Guidant''s MULTI-LINK VISION-Based Everolimus Eluting Stent System

Guidant''s cobalt chromium MULTI-LINK VISION-based stent system, which was evaluated in the SPIRIT FIRST trial, utilizes everolimus with a durable polymer. The company''s clinical trials utilizing durable polymer technology are identified by the SPIRIT designation in the study name.

The initial trial in the SPIRIT series, SPIRIT FIRST, enrolled a total of 60 patients at multiple sites in The Netherlands, Denmark and Germany. Data from the trial will support filings for both a pivotal trial to obtain approval to market the product in the United States and an additional European study.

The CHAMPION Everolimus Eluting Stent System

Guidant''s CHAMPION(tm) Everolimus Eluting Stent System utilizes a bioabsorbable polymer on a stainless steel stent platform with Guidant''s MULTI-LINK VISION® Delivery System. Guidant''s clinical trials employing bioabsorbable polymer technology utilize the FUTURE designation in the study name.

FUTURE I and FUTURE II evaluated safety and performance of an everolimus eluting stent with a bioabsorbable polymer drug carrier and stainless steel stent platform. Results from the FUTURE I and II clinical trials demonstrated safety and efficacy. There was a profound effect in preventing in-stent restenosis (binary angiographic restenosis), with no restenosis at six-month follow-up among patients receiving an everolimus eluting stent (0/46) and an 87 percent reduction of in-stent late loss compared to a metallic stent control. In-stent late loss at six-month follow-up for the everolimus eluting arm of Future I and Future II was .11 mm and .12 mm, respectively. MACE at six-month follow-up for the everolimus eluting arm of Future I and Future II was 7.7 percent and 4.8 percent, respectively.

FUTURE III is an 800-patient clinical trial that will provide additional safety and performance data to support market launch of the CHAMPION Everolimus Eluting Coronary Stent System outside the United States. Another planned trial, FUTURE IV, is a 975-patient U.S. pivotal trial for the CHAMPION Everolimus Eluting Coronary Stent System.