Dec 11, 2001
Guidant Files with FDA for Next-Generation Intravascular Radiotherapy Systemment for High Surgical-Risk Patients

GALILEO III System Designed to Enable Physicians to More Easily and Precisely Treat Longer Heart Blockages

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, announced today that it has submitted a pre-market approval supplement (PMAS) to the U.S. Food and Drug Administration (FDA) for its next-generation radiotherapy system, the GALILEO(tm) III Intravascular Radiotherapy System. Intravascular radiotherapy is one of the most advanced therapies currently available for the treatment of in-stent restenosis, the recurrence of a blockage in a coronary artery that has previously been propped open with a coronary stent. Restenosis occurs in as many as 20 percent of patients who receive coronary stents each year.

"Guidant's filing for the next generation GALILEO system within weeks of receiving FDA approval of the current system, demonstrates our commitment to advancing this highly effective therapy for treating in-stent restenosis," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The development of intravascular radiotherapy, along with current and future technologies such as drug-eluting stents, demonstrates Guidant's commitment to provide physicians a comprehensive array of clinically relevant solutions to treat coronary artery disease."

The investigational GALILEO III system features automated stepping, designed to enable physicians to more easily and precisely treat longer lesions (blockages). The new system delivers radiation therapy starting at the far end of the lesion and automatically steps, or repositions, the radiation source to treat the entire length of the lesion. The current generation GALILEO system allows the physician to treat longer lesions via manual tandem repositioning.

Pending approval of the next generation GALILEO system, customers with existing systems will be automatically upgraded at no additional costs.

Guidant received FDA approval for its current-generation GALILEO Intravascular Radiotherapy System on November 2, and is aggressively pursuing an installation program to meet the needs of its customers who are excited to adopt this new technology.

The PMAS filing for the new GALILEO III system is based on data from the GALILEO INHIBIT Trial. Results of the trial were announced at the 74th Annual Scientific Sessions of the American Heart Association earlier this month.

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.