Dec 8, 2000
Guidant Announces FDA Approval of the FINELINE II Sterox Family of Pacing Leads

Indianapolis, IN and St. Paul, MN - Guidant Corporation (NYSE and PCX: GDT), a worldwide leader in cardiovascular technologies that save and improve lives, today announced that it has received U.S. Food and Drug Administration (FDA) approval to market the FINELINE(tm) II Sterox pacing lead family. Pacing lead systems connect pacemakers with the heart, transmitting electrical signals that enable the device to monitor heart activity and deliver appropriate therapy. Guidant anticipates launching the FINELINE II Sterox lead family in the United States in February 2001.

"We are excited to have the FINELINE II Sterox pacing leads join our family of pacing lead systems," said Fred McCoy, president of Guidant's Cardiac Rhythm Management Group. "With FINELINE leads, physicians choose a lead family that is both highly reliable and simple to implant."

The FINELINE II Sterox lead features the best attributes of Guidant's original FINELINE and FINELINE II pacing lead systems, with the added advantages of a steroid-eluding tip on Guidant's revolutionary coated-wire, co-radial, bipolar lead. The unique design of the FINELINE pacing lead provided an extraordinary reliability record of 99.7 percent survivability after 72 months.

"By adding a steroid-eluding tip to the FINELINE's already excellent acute and chronic pacing thresholds, we notice significantly lower threshold differences, which allows a patient's heart to pace with even less energy," said Thomas R. Winkler, M.D., clinical investigator and chair of the department of cardiac surgery at Salem Hospital in Salem, Ore. "Further, FINELINE leads are small but durable because they have triple insulation. Each conductor is separately insulated and surrounded by polyurethane or silicone."

In addition to the new steroid-eluding tip, the FINELINE II Sterox pacing lead family features industry-unique benefits, including:

• IROX(tm) Coated Electrodes. A unique iridium oxide coating is applied to the tip electrodes providing lower acute and chronic pacing thresholds.

• Co-radial Design. Each individual conductor is separately insulated with ethylene tetrafluoroethylene (ETFE) and then wound together in parallel into a single coil. This construction allows for a thinner lead body.

"The approval of the FINELINE II Sterox lead family, yet again, demonstrates Guidant's technology leadership," said Mark Bartell, president of Guidant Sales Corporation of the United States. "We are confident that the introduction of these leads will further strengthen our leadership position in the pacing lead market and gain competitive market share."

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