Data presented today at Heart Rhythm
2013, the Heart Rhythm Society's 34^th Annual Scientific Sessions, show that
Medtronic MDT Lead Integrity Alert (LIA) software detected
pace/sense lead issues in non-Medtronic leads at a greater rate than standard
impedance monitoring alone (impedance monitoring measures the electrical
continuity of a lead four times per day). The retrospective analysis, which
focused on Endotak® leads (Boston Scientific) and was presented by Dr. Kenneth
Ellenbogen, shows that for every one Endotak pace/sense lead issue detected by
impedance monitoring, the LIA software detected four cases that impedance
monitoring alone missed. LIA is not currently FDA approved for use with
non-Medtronic leads.
Data previously presented at the American Heart Association Scientific
Sessions in 2012 showed that for every one Riata® pace/sense lead (St. Jude
Medical) issue detected by impedance monitoring, the LIA software detected
approximately six cases that impedance monitoring alone missed.
Approved by the FDA in 2008 for use with Medtronic defibrillators and leads,
LIA is proprietary and exclusive software that resides on Medtronic devices.
Medtronic has submitted a PMA-Supplement requesting FDA approval to add LIA
performance on non-Medtronic leads to the device labeling.
"We've seen the effectiveness of the LIA software with Medtronic devices and
leads these past four years, but physicians have been asking about its use
with other manufacturers' leads," said Marshall Stanton, M.D., vice president
and general manager, Implantable Defibrillator Business, Cardiac Rhythm
Disease Management at Medtronic. "This analysis underscores our commitment to
providing implanting physicians with the latest clinically relevant, advanced
decision-making tools to benefit the health and well-being of their patients."
In the U.S., approximately 17,000 Medtronic LIA-enabled defibrillators (ICDs
and CRT-Ds) are connected to non-Medtronic leads, as identified and monitored
remotely via the Medtronic CareLink® Network. This includes approximately
7,700 Endotak leads; 8,800 Riata/Durata® leads from St. Jude Medical; and
nearly 500 leads from other manufacturers, including Biotronik and others.
Non-Medtronic lead issues identified by LIA were adjudicated by an external
panel of physicians who had access to device-stored electrograms and the
clinical interpretation of the treating physician.
"These findings shed light on the applicability of Medtronic's LIA-enabled
defibrillators in detecting lead issues in those leads developed by other
manufacturers," said Dr. Ellenbogen, Kontos Professor of Cardiology at the
Medical College of Virginia.
In collaboration with leading clinicians, researchers and scientists
worldwide, Medtronic offers the broadest range of innovative medical
technology for the interventional and surgical treatment of cardiovascular
disease and cardiac arrhythmias. The company strives to offer products and
services that deliver clinical and economic value to healthcare consumers and
providers worldwide.
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 periodic reports on file with the Securities
and Exchange Commission. Actual results may differ materially from anticipated
results.
Market News and Data brought to you by Benzinga APIs© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in