Nov 5, 2001
Guidant's Automated Radiotherapy Treatment for Coronary Artery Disease Receives FDA Approval

GALILEO System Sets New Standards of Precision and Ease of Use

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 received U.S. Food and Drug Administration (FDA) approval of the GALILEO(tm) Intravascular Radiotherapy System for the treatment of in-stent restenosis. The GALILEO System was approved in Europe in May 2000. In-stent restenosis refers to the recurrence of a blockage in a coronary artery that had been previously propped open with a coronary stent. This condition affects as many as 20 percent of patients treated with coronary stents each year.

"Radiation is still the only FDA approved method to treat in-stent restenosis, and this product represents a significant advance because of its precision, automation and ease-of-use," said John M. Capek, Ph.D., president, Vascular Intervention, Guidant Corporation. "The GALILEO System is part of our ongoing commitment to provide innovative, clinically relevant solutions to physicians treating cardiovascular disease. It is an integral component of Guidant's comprehensive line of vascular intervention products, which will include drug-coated stents going forward."

Guidant expects to start shipping its system to hospitals immediately, and already has in place comprehensive licensing, technical and training support capabilities.

"There is compelling clinical evidence that radiation therapy should be the treatment of choice for in-stent restenosis," added Ron Waksman, M.D., associate director, division of cardiology, Washington Hospital Center in Washington, D.C. "This approval is good news for the cardiologist and radiation oncologist team, and the GALILEO system will expand physicians' options for treating different types of patients with coronary artery disease."

Radiation therapy for the treatment of coronary artery disease has brought together physician specialists who work as a team to deliver treatment: the patient's cardiologist, who provides the diagnosis and treatment plan, and the radiation oncologist, who is licensed to deliver the therapy.

"The advanced technology of the GALILEO system makes it much easier for the physician team to work together," said Prabhakar Tripuraneni, M.D., F.A.C.R., a world-renowned radiation oncologist from Scripps Clinic in La Jolla, California. "It has built-in measures to improve safety and ease of delivery. This system also gives the radiation oncologist an effective treatment choice in decreasing in-stent restenosis in a broader range of patients."

The GALILEO system is comprised of three components: a centering catheter, a source wire and a source delivery unit. The centering catheter is designed to ensure that radiation is applied evenly within the artery during treatment. The device automatically advances, retracts, stores and shields the radioactive source wire that provides the treatment. Further, the source delivery unit automatically calculates the correct dose of radiation needed, eliminating the need for physicians to perform time-consuming calculations and reducing the possibility of human error.

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.