Oct 9, 2001
Guidant Announces CE Mark Approval and First Implants of Advanced Pacemaker System

New Pacemaker Offers Advanced Therapy, Comprehensive Patient Management and Ease-of-Use Features

Indianapolis, IN - Guidant Corporation (NYSE and PCX: GDT), a world leader in the treatment of cardiovascular and vascular disease, today announced CE Mark approval and first implants of its newest pacemaker line-the INSIGNIA(tm) family of pacemakers.

"The INSIGNIA family of pacemakers represents Guidant's most advanced pacemaker family ever," said Fred McCoy, president, Cardiac Rhythm Management, Guidant. "We are pleased to offer our physician-customers optimal therapy and comprehensive patient management in a flexible and easy-to-use pacing system."

Five implants occurred on the first day of the device's availability in centers across Europe: Kerckhoff Klinik (Bad Nauheim, Germany), Otto-von-Guericke-Universitätsklinik (Magdeburg, Germany), Policlinico San Orsola (Bologna, Italy), Kardioangiologisches Zentrum Bethanien (Frankfurt, Germany), and St. Thomas Hospital (London, U.K.).

This pacemaker family exemplifies Guidant's commitment to providing advanced therapy by offering its proprietary blended-sensor technology designed to measure patient workload through respiration and motion, providing optimal rate response based on the patient's activity. The INSIGNIA pacing system offers comprehensive patient management by offering 110 seconds of Electrogram (EGM) storage-nearly three times the EGM storage of previous Guidant devices. EGMs give the physician a recording of the electrical activity occurring within the heart.

The INSIGNIA pacing system's unique teardrop shape and smaller size give the device a more physiologic dimension intended to facilitate insertion during implant. In addition to being smaller than previous Guidant pacemakers, this new platform also offers improved longevity over its predecessors.

The pacemaker also includes ease-of-use features that allow the clinician to easily and quickly perform a comprehensive set of patient follow-up tests. The result is a single concise report that summarizes data needed for informed patient management.

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.