GDT Guidant Corp

Guidant Corporation (NYSE:GDT) today announced U.S. Food and Drug Administration (FDA) approval of its CONTAK RENEWAL(R) 3 RF cardiac resynchronization therapy defibrillator (CRT-D) for heart failure patients and the ZOOM (R) LATITUDE(TM) programmer. The RENEWAL 3 RF CRT-D is Guidant's first wandless cardiac resynchronization therapy device. The ZOOM LATITUDE programmer is a next generation programmer designed to interface with devices that include remote monitoring capability, such as the RENEWAL 3 RF, as well as the current global implant base of Guidant devices. This wireless system is designed to save physicians and patients time during implant and at follow-up, with device interrogations that can be three times faster than Guidant's previous programmer. In addition, Guidant's wireless communication technology removes the programmer wand from the sterile implant field. Guidant plans to introduce these products in the U.S. during the fourth quarter of this year. "The RENEWAL 3 RF and ZOOM LATITUDE programmer represent a new era in device management. These introductions demonstrate Guidant's ongoing commitment to provide innovative technologies designed to deliver physician convenience and patient benefit," said Fred McCoy, president, Cardiac Rhythm Management, Guidant Corporation. "These approvals are tangible evidence of Guidant's efforts working with the FDA to bring new products to market in a timely fashion." The RENEWAL 3 RF and ZOOM LATITUDE programmer are the cornerstones of the LATITUDE Patient Management system. The anticipated advantages of this system include speed, convenience and patient care. -- Speed: By utilizing the ZOOM LATITUDE programmer with the RENEWAL 3 RF CRT-D device, physicians can interrogate devices three times faster than Guidant's previous programmer, which saves time at implant and follow-up. -- Convenience: Wireless interrogations may make follow-up visits more convenient. -- Patient Care: Wireless interrogations may make follow-up visits faster and more convenient. The RENEWAL 3 RF CRT-D and ZOOM LATITUDE system are designed to add additional follow-up capability, pending FDA approval. CONTAK RENEWAL 3 and 4 Update As previously announced, Guidant received approval earlier this month from U.S. and European regulatory authorities to re-introduce the CONTAK RENEWAL 3 (U.S.) and 4 (outside the U.S.) family of CRT-D devices. With the re-launch of these devices, Guidant's full product line is now available to physicians and patients. McCoy commented, "Our progress toward full inventory availability is ahead of schedule. Already we have achieved an inventory position to meet all current implant demand and to replenish customer inventory." 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. NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. This release includes forward-looking statements concerning the product launch and use of the therapy. The statements are based on assumptions about many important factors, including ordinary production and marketing operations, any regulatory developments, and other factors identified on Exhibit 99.1 to the company's most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements.