Medtronic Newsroom
 
 

News Releases

 



This information is intended for media professionals and investors

News Release

Medtronic Media Contacts:
Jeff Warren, Investor Relations, 763-505-2696
Kyra Schmitt, Public Relations,

Lead Integrity Alert™ (LIA) – “alarm system” FOR Implantable CARDIAC Defibrillators

Company’s Latest Product Advancement is an Industry First; New Alert Gives Patients Advance Notice of a Potential Lead Fracture, Designed to Help Reduce Shocks


MINNEAPOLIS – Sept. 4, 2008 – Medtronic (NYSE: MDT)  has received both U.S. Food and Drug Administration as well as CE Mark approval for our newest device safeguard, the Lead Integrity Alert™ (LIA) software – an important milestone in our company’s broader innovation strategy, and one which demonstrates our continued commitment to patients.  LIA was designed to provide patients with certain Medtronic defibrillators and defibrillator leads with more advance notice – via an audible sound – of a potential lead fracture that could result in an unnecessary shock. 

Our commitment to improving the lives of patients with heart disease led to the development of LIA, which offers additional protection for defibrillator patients and a new level of technology for clinicians. 

Kenneth A. Ellenbogen, M.D., Kontos Professor of Cardiology at the Medical College of Virginia, who worked with Medtronic on LIA, recently stated his views on the product.  He said, “I was involved in early discussions of this product, and have studied its clinical impact throughout its development.  I think LIA is an example of innovation that advances medical care.  I will use LIA to protect my ICD patients against unnecessary shocks that can result from lead fractures.”

About LIA
LIA was designed to enhance lead performance surveillance and patient safety.  In keeping with Medtronic’s comprehensive lead surveillance program – the most robust in the industry – we will conduct an ongoing analysis of LIA and its impact on patient care.

LIA was also developed to enhance patient safety and address patient wellbeing.  We believe it will become a standard of care tool to aid in shock reduction.  Data shows that with LIA, approximately 76 percent of the patients with Sprint Fidelis leads are expected to receive three or more days advance warning of a potential lead fracture which could result in an unnecessary shock, compared to 49 percent who could receive two or more days advance notice without LIA.  This improvement is based on the following LIA features:

  • Improved sensing capabilities to help detect possible lead fractures earlier on;
  • Increased time between detection of a potential lead fracture and potential delivery of a shock
  • 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.

LIA was developed as a software upgrade for nearly all (98 percent) of the Medtronic implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted in the United States, and into 93 percent implanted worldwide.  Pending further regulatory approvals, LIA will be included in all future Medtronic implantable defibrillators. 

Key Advancement Milestone Background
LIA is representative of Medtronic’s commitment to product quality and reliability and to patient safety and care.  Here are some additional examples of the advancements we have made in this area:

  • Medtronic defibrillators equipped with Conexus® Wireless Telemetry are capable of automatically sending a Medtronic CareAlert™ notification of patient condition changes detected by the device to physicians via the Medtronic CareLink® Network.
  • Many of Medtronic’s implantable cardiac devices have long been equipped with a Patient Alert™ feature, which signals when certain changes in the devices, such as lead function, battery condition, therapy delivery, etc., have occurred and should be checked by a physician.
  • Medtronic's newest line of implantable cardiac devices introduces automaticity with Complete Capture Management™, which continuously and automatically adjusts to changing patient needs.
  • Medtronic was the first company to offer anti-tachycardia pacing (ATP) in an ICD.  ATP has been proven to use painless pacing pulses to terminate tachyarrhythmias (dangerously fast heart rhythms), and to eliminate three out of four shocks for tachyarrhythmias.

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.

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.

-end-


Document Options