Medtronic Introduces Industry's First Catheter-Delivered Pacing Lead To Help Facilitate Selective Site Placement In The Right Heart Chambers

Industry's Thinnest Bipolar Pacing Lead Designed for Increased Reliability

Minneapolis - Medtronic, Inc. today announced the U.S. introduction of the SelectSecure Lead System, which received approval by the U.S. Food and Drug Administration on Aug. 3, 2005. The SelectSecure pacing lead (Model 3830) is the world's thinnest bipolar lead. Its unique, lumenless design allows for flexibility and a smaller body size (4.1 F) without sacrificing insulation thickness.

Additionally, the SelectSecure system is the industry's first lead designed to enable physicians to reach selective sites of the right heart. The system utilizes a deflectable catheter to allow positioning of the lead in select locations in either the right atrium or ventricle. The SelectSecure pacing lead and SelectSite catheter can be used with pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, including CRT-pacemakers and CRT-defibrillators.

Since the advent of pacing technology more than 50 years ago, leads typically have been designed to be placed in the apex of the right ventricle or right atrial appendage. However, recent studies have shown that right ventricle (RV) apical pacing may cause mechanical and electrical dyssynchrony, which in turn may increase the patient's risk of atrial fibrillation and heart failure hospitalizations.

"The right ventricular apex is recognized as an 'easy' site to implant pacemaker leads. However, evidence continues to mount that the RV apex may not be the best site clinically from which to pace, because it can potentially lead to chronic heart failure and arrhythmias," said Randy Lieberman, M.D., director of Cardiac Electrophysiology at Harper University Hospital, Detroit Medical Center. "I believe the Medtronic SelectSecure pacing system is a revolutionary change in pacing. The system enables a physician to deliver what is currently the market's smallest pacing lead. This new lead, coupled with the steerable catheter-delivery technology, gives the physician a secure method to implant in RV sites away from the apex that may improve clinical outcomes."

The SelectSecure system is a key element of Medtronic's Physiologic Pacing Program, or MP3, a comprehensive initiative to help educate physicians on recent clinical evidence about ventricular pacing, and provide tailored solutions to either promote or mimic a patient's normal cardiac function.

"The SelectSecure system will raise the bar for pacing leads, giving physicians greater control to place the lead at the best location in each patient's right heart chambers for optimal delivery of therapy," said Steve Mahle, president of Medtronic Cardiac Rhythm Management. "Knowing when to pace the heart, and from where to pace is critical to reducing co-morbidities in these patients. This system is a prime example of our continued commitment to establishing innovative technology that benefits patients and physicians."

SOURCE; Medtronic Inc.