Sep 19, 2001
Guidant Announces Significant Progress in its Multiple Programs for Drug-Coated Stents

Guidant Completes ACTION Clinical Trial Enrollment for FDA Filing; Company Confirms Submission of PMA Amendment for Heart Failure Technology

Guidant Completes ACTION Clinical Trial Enrollment for FDA Filing; Company Confirms Submission of PMA Amendment for Heart Failure Technology Indianapolis, Ind. - Guidant Corporation (NYSE and PCX: GDT) today announced that it has enrolled 94 patients in its international ACTION clinical trial supporting Guidant's internal PHARMA-LINK? Drug Eluting Stent Program, utilizing Actinomycin D. After a six-month follow-up, data from the first 90 patients of this study will be used to file with the U.S. Food and Drug Administration (FDA) for Guidant to begin it's pivotal study in the United States. Further, as reported at the recent Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C., pre-clinical results continue to look positive, with evidence of complete healing at 90 days and no adverse thrombotic events.

"ACTION is a critical trial in the development of drug-coated stents," commented Professor Patrick Serruys, M.D., of Erasmus University and the Thoraxcentre Hospital in Rotterdam, the Netherlands. "I have been impressed by the pre-clinical Actinomycin data to date and am eagerly awaiting the results of this clinical trial early next year."

Also, as announced last month, Guidant and Cook Incorporated signed a distribution agreement in which Guidant will be the exclusive worldwide distributor of a new paclitaxel-coated stent to be developed and manufactured by Cook. Building on its presentation at the TCT conference last week, Cook today discussed the results of two important clinical studies that demonstrate preliminary safety and efficacy of paclitaxel-coated stents. Guidant congratulates Cook and Angiotech Pharmaceuticals Inc. on these highly positive results.

"We are extremely pleased with the rapid progress we are making on both of these important programs," said Ronald W. Dollens, president and CEO, Guidant Corporation. "This affirms our commitment to pursuing multiple options for drug-coated stent technologies that have the potential to provide meaningful clinical benefits to millions of patients with coronary artery disease."

The successful results of Cook's clinical trials will, in part, form the basis of the regulatory filings for a paclitaxel-coated stent incorporating Guidant's stent and stent delivery system technologies. Guidant expects, subject to FDA approval, these trials to commence in the United States in the fourth quarter of this year.

The company also commented on the recent Boston Scientific "Notice of Action" regarding Guidant's collaboration with Cook. "We have full confidence in Cook's analysis that Cook was fully within its rights to execute a distribution agreement," commented Dollens. "We are moving forward with this important technology and look forward to a near-term submission to the FDA."

The company also announced a favorable federal appellate court decision last week affirming the strength of Guidant's rapid exchange intellectual property. The appellate court's decision, coupled with the recent announcement that confirmed a binding arbitration panel decision in favor of Boston Scientific, further strengthens Guidant's market leadership position.

Guidant also provided an update on its CONTAK CD(tm) regulatory filing, confirming that it had submitted a PMA amendment to the FDA on Sept. 6. The amendment provides additional data, including more patients, longer follow-up and statistical analysis encompassing all groups of patients. Guidant looks forward to our continuing discussions with the FDA on this matter.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to 7 million cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 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.