Sep 19, 2005
Guidant Announces FDA Approval of Wireless Home Patient Management System

Innovative Technology Directed Toward Compliance in Heart Failure Patients at Risk of Sudden Cardiac Death

Indianapolis, Ind. and St. Paul, Minn. - Guidant Corporation (NYSE: GDT) today announced U.S. Food and Drug Administration (FDA) approval of the LATITUDE® Communicator, and secure data storage system. These elements represent the final components of the LATITUDE Patient Management system, which presently can be used with the CONTAK RENEWAL® 3RF cardiac resynchronization therapy defibrillator (CRT-D) and the ZOOM® LATITUDE(tm) Programmer. Patients and physicians now have the ability to conduct wireless, automatic device data uploads from the comfort and convenience of the patient''s home. Wireless, automatic data uploads are designed to make the device and patient follow-up process easy for patients and more efficient and effective for physicians.

The LATITUDE Communicator, an easy-to-use in home monitoring device for patients, wirelessly reads implantable device information at times specified by the patient''s physician. The Communicator transmits the data to a secure Internet server where the physician can then access this medical information anytime, from anywhere. In addition to wireless, automatic device data uploads, the Communicator enables LATITUDE Active Monitoring(tm) of the RENEWAL 3RF CRT-D device. LATITUDE Active Monitoring is a daily confirmation of the patient''s device status, providing confidence and assurance that the device is operating properly. RENEWAL 3RF with LATITUDE Active Monitoring represents a new category of remote patient management, offering actionable information that is both relevant and timely.

"This wireless system is designed to improve patient compliance independent of patient effort and gives me the ability to more closely monitor my patients without increasing my work," said Dr. Bruce Wilkoff, Cleveland Clinic, Cleveland, Ohio. "With LATITUDE Active Monitoring, I hope to provide my patients the peace of mind that comes from knowing their device status is being monitored daily in their home."

"The LATITUDE Patient Management system represents a tremendous step forward in technology innovation," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "These innovative solutions further support Guidant''s ongoing commitment to bring physicians increasingly effective tools to help patients with heart failure and patients at risk of sudden cardiac death."

The LATITUDE Patient Management system is comprised of the following components:

• LATITUDE Communicator: The in-home monitoring unit automatically and wirelessly reads implantable device information at times specified by the patient''s physician thereby helping drive device follow-up compliance. The Communicator sends the data that it collects to a secure data storage system, which can be accessed by clinicians through a secure web server accessible from any Internet-connected PC.
• LATITUDE Website: The secure web server provides anytime, anywhere access to the comprehensive Guidant device and patient data collected by the LATITUDE Communicator. The Internet based system provides a digital archive for patient data as well as robust reporting capabilities. Reports can be emailed, printed or saved to a computer or electronic medical record (EMR). Moreover, physicians can schedule when device data downloads occur so they know when to expect patient information to appear on the website.
• CONTAK RENEWAL 3RF CRT-D: Guidant''s first wireless enabled implantable device is designed for speed and convenience at implant and sets a new standard for heart failure management with the introduction of LATITUDE Active Monitoring.
• ZOOM LATITUDE Programmer: The wireless programmer is designed to save physicians time with data collection and programming speeds that are three times faster than Guidant''s previous programmer. It also allows removal of the programming wand, traditionally necessary for device communication, from the sterile implant field.

Available as an optional component to the system is the LATITUDE Weight Scale and Blood Pressure Monitor. These wireless heart failure management tools provide timely access to patient diagnostics of known clinical value. Weight and blood pressure data is captured wirelessly by the LATITUDE Communicator and sent to the secure server for review by the patient's physician. This weight and blood information is then immediately available to patients in their home to assist their compliance with the day-to-day and home-based heart failure instructions prescribed by their physician.

"Weight and blood pressure are standard of care for monitoring advanced heart failure patients," said Dr. Brian Jaski, Sharp Memorial Hospital, San Diego, California. "LATITUDE will enable better management of patients by easily tracking these intuitive diagnostics from the patient's home."

While FDA has just approved the final components of the wireless remote system for use in the home, the in-clinic device data management capabilities of the LATITUDE Patient Management system have been available for use since November of 2004.

"Customer response to the LATITUDE Patient Management system has been tremendous," said John Russell, vice president and general manager for Guidant Patient Management. "In less than a year since launch of LATITUDE for the clinic, 250 physician practices have become licensed to use LATITUDE and more than 8,000 patients are now on the system. We look forward to building on this reception as we launch the wireless LATITUDE remote capabilities for use in the home."

Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of more than 12,000 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. For more information visit www.guidant.com.