Sep 29, 2000
Guidant Supports UK Institute''s Guidance on Implantable Defibrillators

National Institute for Clinical Excellence Recommends Three-Fold Increase in Defibrillator Use

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a global leader in the medical technology industry, today announced support for the official guidance issued today advocating a significant increase in the use of implantable defibrillator technology to treat patients who are at risk of sudden cardiac death (SCD).

The guidance was issued by the National Institute for Clinical Excellence (NICE), a Special Health Authority for England and Wales. NICE has recommended to the government''s National Health Service (NHS) that the utilization rate of implantable defibrillators among the population in England and Wales be raised from the current estimate of 17 per million population to 50 per million. The guidance positions the UK''s implantable defibrillator usage in line with published guidelines from several countries in Western Europe.

NICE''s guidance on implantable defibrillators follows a comprehensive assessment of the effectiveness of implantable defibrillators in treating life-threatening arrhythmias (abnormal rhythms of the heart). Representatives from industry, physician groups and patient associations submitted the evidence for evaluation by the NICE appraisal committee. Guidant put forward its report both independently and jointly with other manufacturers in a European Confederation of Medical Devices Association (EUCOMED) working group.

"We are pleased with the clinical guidance issued by NICE as it is a fair and balanced appraisal that offers new hope to the thousands of people in the UK whose lives are at risk from sudden cardiac death," commented Guido Neels, president, Guidant European operations. "We will continue to work closely with the UK''s medical community and the government to further educate and promote the use of this lifesaving technology."

According to NICE''s findings, cardiovascular disease is the leading cause of death in the UK, claiming more than 300,000 victims annually. Sudden cardiac death represents some 25 percent to 30 percent of all cardiovascular deaths, claiming an estimated 70,000 to 90,000 lives each year. SCD is defined as an abrupt loss of consciousness and unexpected death due to cardiac causes, which occur within one hour of the onset of symptoms. About 80 percent of SCD events are caused by ventricular tachyarrhythmias (abnormal heart rhythms that originate in the lower chambers of the heart) and ventricular fibrillation.

Implantable defibrillators have been shown in clinical studies to greatly reduce the risk of sudden cardiac death. The results of three widely publicized clinical trials analyzed by NICE during the appraisal process demonstrated that implantable defibrillators, when compared to conventional drug therapy, clearly and significantly reduced deaths. The studies showed that implantable defibrillators had a relative risk reduction of 27 percent for total mortality, and 52 percent for arrhythmic death.

"Implantable defibrillator therapy has a proven efficacy in preventing sudden cardiac death as NICE has recognized," commented John M. Morgan, M.D., of the Wessex Cardiothoracic Centre. "The support of NICE for implantable defibrillator therapy will help bring the treatment of dangerous heart rhythms in UK patients more into line with the rest of Europe and offer them increased longevity and a better quality of life."

The guidance regarding implantable defibrillators follows a recommendation by NICE in April of this year to increase the utilization rate for coronary stents from an average of 69 percent in 1998 to 80 percent of total percutaneous (through the skin) coronary interventions, or balloon angioplasty procedures - making it the standard treatment for people suffering from angina and heart attacks in the UK.

"NICE''s recommendation today coupled with its previous guidance relative to the use of stents is clear evidence of the Institute''s efforts to promote the best practices in cardiovascular healthcare," commented Neels. "We look forward to working closely with NICE in the future as the institute continues to advance the government''s recently stated objectives of vastly improving the country''s cardiac health by identifying novel medical solutions to effectively treat cardiovascular disease."

Earlier this year, the NHS established a National Service Framework for Coronary Heart Disease to improve cardiac health care services and reduce deaths and disabilities related to cardiac disease among the UK population. The government''s objective is to help the country save up to 200,000 lives by 2010. The Commission for Health Improvement, also part of the NHS, will regularly monitor the implementation of the NICE guidance by clinicians across the country.

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.