Jun 5, 2001
Guidant Receives European Approval to Treat Long Coronary Blockages with Radiotherapy

Approval Will Allow Physicians to Treat a Greater Number of Patients

Indianapolis, Ind. and Santa Clara, Calif. - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of coronary artery disease, today announced it has received European CE Mark approval for its GALILEO(tm) Intravascular Radiotherapy System to treat blockages (or restenosis) in coronary arteries less than or equal to 47 mm in length using tandem positioning. This approval will allow physicians in Europe to treat longer coronary blockages, making the therapy available to a larger patient population.

"Long coronary blockages are inherently higher risk cases, since patients with this type of coronary artery disease tend to have a higher likelihood of developing re-blockages following traditional treatment with coronary angioplasty or stent implantation," said Pieter R. Stella, M.D., of the Heart Lung Center at the University Medical Center in Utrecht, the Netherlands. "Having already successfully treated patients using the single-step GALILEO System, I am pleased to have the ability to now use intravascular radiotherapy in cases that involve longer lesion coronary artery disease."

This latest approval marks Guidant's GALILEO System as the only intravascular radiotherapy system having CE Mark approval for treating both longer coronary blockages up to 47 mm in length and smaller diameter arteries as small as 2.4 mm in diameter. Patients with these types of coronary blockages are generally prone to higher rates of restenosis.

Tandem positioning allows a physician to place the GALILEO System's 27 mm centering catheter in one section of a long coronary blockage and treat the area with a small dose of radiotherapy. The physician then manually moves the centering catheter to treat the remaining portion of the blockage.

"We welcome the opportunity to expand the cases in which physicians can use intravascular radiotherapy," said Guido J. Neels, president of Guidant Europe, Middle East, Africa and Canada. "Guidant's GALILEO System is now uniquely poised as a treatment option for a larger patient population afflicted with coronary artery disease."

Clinical trials to date have shown that small amounts of radiation applied to blocked coronary arteries appear to stop cell growth that can cause re-blockages to form in previously treated arteries. Approval for treating long lesions was based on data from the INHIBIT (INtimal Hyperplasia Inhibition with Beta In-stent Trial) clinical study. Results from the INHIBIT trial showed an angiographic restenosis rate of 26 percent for radiotherapy patients as compared to 52 percent for patients in the control group. The INHIBIT trial was a randomized, multi-center study that enrolled patients who required treatment for re-blockages within stents in native coronary arteries.

Guidant Corporation pioneers lifesaving technology, giving an opportunity for a 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.