Aug 30, 2000
Guidant Initiates Peripheral Stent Trial

Study Examines Alternative Treatment for Hypertension Caused by Renal Artery Disease

Indianapolis, Ind. and Santa Clara, Calif. - Patients suffering from high blood pressure caused by renal artery disease may soon have a treatment alternative that may offer improved results over the traditional method of therapy by angioplasty. Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of peripheral vascular disease, has implanted the first patient in a clinical trial to determine the safety and efficacy of renal artery stenting in hypertensive patients.

This study, known as HERMES (HERculink Multicenter Evaluation of Renal Stenting), is a prospective, non-randomized trial that will enroll approximately 250 patients who have experienced unsatisfactory results from angioplasty to treat blockages in renal arteries. This clinical study will be conducted at 25 sites throughout the United States. Guidant''s RX HERCULINK(tm) 14 Peripheral Stent System is the exclusive device used in this study.

The HERCULINK System is currently being marketed for peripheral vascular indications in Europe and in other countries that base regulatory approval for medical devices on the European CE Mark. It is currently approved in the U.S. and Canada for the treatment of malignant biliary duct obstructions.

"Guidant''s HERCULINK Stent appears to successfully address many of the procedural challenges physicians face when treating patients with renal artery disease," said Stephen Ramee, M.D. of the Alton Ochsner Medical Foundation in New Orleans, LA., who will oversee the HERMES trial as principal investigator. "It delivers the radial strength needed to treat tight lesions and is still flexible enough to negotiate through the tighter curves commonly encountered in the renal vasculature."

Renal artery disease frequently causes stenosis, which is the narrowing of blood vessels in the kidneys that restricts normal blood flow. Renal artery stenosis can cause hypertension or exacerbate existing cases of hypertension, as it often aggravates elevations in blood pressure. According to the American Heart Association (AHA), high blood pressure is the leading modifiable risk factor for stroke. AHA statistics also show that patients with high blood pressure are three times more likely to develop coronary heart disease and six times more likely to develop congestive heart failure.

A common method of treatment for hypertensive patients with renal artery stenosis is angioplasty, which utilizes a balloon dilatation catheter to expand the blocked area of the artery and restore normal blood flow. Clinical studies have shown, however, that as many as one-third of patients who receive angioplasty experience restenosis - re-occurring blockages of treated arteries - and require repeat visits to their physicians. If left untreated, renal artery stenosis may compromise kidney function and in some cases, lead to acute or chronic kidney failure.

"Guidant is hopeful that the HERMES trial will help demonstrate that stenting is a safe and effective treatment for patients suffering from high blood pressure caused by renal artery disease," said John M. Capek, Ph.D., president of Guidant''s Vascular Intervention Group.

A global leader in the medical technology industry, Guidant Corporation provides innovative, minimally invasive and cost-effective products and services for the treatment of cardiovascular and vascular disease.