Lead Integrity Alert™ Shown to Reduce Unnecessary Shocks

MINNEAPOLIS--(BUSINESS WIRE)--According to a study to be published in the Nov. 18 issue of the journal Circulation, Medtronic’s Lead Integrity Alert™ (LIA) significantly improves early identification of potential implantable cardioverter-defibrillator (ICD) lead fractures. LIA offers added protection for ICD patients through more frequent audible alarms and is the first continuous ICD monitoring technology that triggers real-time device changes to reduce unnecessary shocks that could result from potential lead fractures. Study results showed LIA provided at least a three-day advanced warning of unnecessary shocks in 76 percent of patients. In the analysis of about 16,000 patients, when the LIA alert was triggered, 72 percent of alerts were lead fractures and 81 percent of alerts were lead fractures or header connector problems requiring surgical intervention. The false-positive rate was one per 372 patient-years of monitoring.

The LIA received both U.S. Food and Drug Administration as well as CE Mark approval in September 2008. Pending further regulatory approvals, LIA will be included in all future Medtronic implantable defibrillators and applies to all Medtronic leads, including the Sprint Quattro Secure S™ lead (Model 6935), which was recently approved in Europe.

“The lead integrity algorithm is an important advance in diagnostics that monitor the integrity of defibrillation leads,” said Charles D. Swerdlow, M.D., cardiac electrophysiologist, Cedars-Sinai Medical Center in Los Angeles and lead author on the study. “It is the first downloadable software developed to enhance the performance of normally-functioning ICDs and the first to trigger real-time changes in ICD parameters to reduce unnecessary shocks caused by lead fractures. Our study demonstrates that the lead integrity algorithm increased the warning time from diagnosis of lead fracture until the patient receives unnecessary ICD shocks caused by the fracture. This algorithm can prevent unnecessary shocks if the patient and physician respond rapidly once an alert is triggered.”

“As part of Medtronic’s ongoing commitment to advance medical care through innovation, LIA was developed to enhance patient safety and wellbeing,” said David Steinhaus, M.D., medical director of the Cardiac Rhythm Disease Management business at Medtronic. “We believe it will become a standard of care tool to aid in shock reduction.”

About Lead Integrity Alert (LIA)

LIA was developed as a software upgrade for nearly all (98 percent) Medtronic ICDs and cardiac resynchronization therapy-defibrillators (CRT-Ds) implanted in the United States, and 93 percent of these implanted worldwide.

The ability of LIA to increase the time between a lead fracture and potential delivery of an unnecessary shock is based on the following features:

• Improved sensing capabilities to help detect possible lead fractures earlier;
• Increased number of intervals required to detect VF (following detection of a lead fracture) to avoid treating lead fractures as VF;
• Increased number of times the audible alert sounds each day so that patients are more likely to hear the alert. Upon hearing the alert, patients should contact their physician;
• Expanded electrogram storage to help clinicians diagnose the cause of the alert.

Sprint Quattro Secure S^TM Available for Use in Europe

Medtronic also recently announced European CE Mark receipt for the Medtronic Sprint Quattro Secure S™ single coil defibrillation lead (Model 6935) for use with implantable defibrillators for those at risk for dangerous tachyarrhythmias (fast heartbeats) and sudden cardiac arrest. This new lead is an addition to the Sprint Quattro line, known for reliability and supported by more than seven years of post-market performance data¹.

The Sprint Quattro Secure S lead is available for use in Asia/Pacific, Canada, Europe, Middle East/Africa and Latin America as of November 2008. Availability in the United States, Japan, and China is expected in the coming months. The Medtronic Sprint Quattro Secure S lead is designed with an 8.6 French diameter lead (approximately 2.8 mm in diameter), providing an option for physicians who prefer a single coil lead for patients with unique anatomies and is designed to help reduce tip pressure. This new lead is also compatible with any Medtronic ICD or CRT-D device, including those within the company’s new Vision 3D™ portfolio.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Editor’s Note:

¹This prospective, multicenter clinical study, the Medtronic System Longevity Study (SLS), has been capturing data for more than 25 years and is designed to monitor the performance of commercially available implantable cardiac leads and devices. The study contains clinical data from more than 75,000 leads, of which more than 15,000 are currently active. The Sprint Quattro Secure lead family is among these active leads and has 1,367 enrollments with 51,903 cumulative months of follow-up as of July 31, 2008. For more information, visit www.CRDMPPR.medtronic.com.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 25, 2008. Actual results may differ materially from anticipated results.