Feature | November 07, 2013

FDA Approves Medtronic Software for Use With Non-Medtronic Leads to Detect Defibrillator Lead Issues

LIA software proven to detect lead failures more frequently than impedance alone on Riata, Durata and Endotak Leads

November 7, 2013 — Medtronic Inc. announced U.S. Food and Drug Administration (FDA) approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic leads. Proprietary and exclusive software that resides in Medtronic defibrillators, LIA is now approved to report performance issues on Durata and Riata defibrillator leads (St. Jude Medical) and Endotak (Boston Scientific) defibrillator leads when connected to a Medtronic device.
 
Originally approved by the FDA in 2008 for use with Medtronic defibrillators and leads, LIA has displayed the ability to detect pace/sense lead issues in non-Medtronic leads at a greater rate than standard impedance monitoring alone, according to an analysis recently published in Circulation: Arrhythmia and Electrophysiology.  For Durata and Riata leads (St. Jude Medical), LIA software detected pace/sense circuit issues approximately six times more frequently than with impedance monitoring.  The software detected pace/sense circuit issues more frequently for Endotak (Boston Scientific) leads as well.
 
"This approval affirms the applicability of Medtronic's LIA-enabled defibrillators in detecting lead issues in those leads developed by other manufacturers," said Kenneth Ellenbogen, M.D., Kontos Professor of Cardiology, Virginia Commonwealth University (VCU) School of Medicine and Medical College, Virginia Hospital.
 
In the United States, approximately 12,000 Medtronic LIA-enabled defibrillators (implantable cardioverter defibrillators (ICDs) and cardiac resynchronizationtherapy devices (CRT-Ds)) are connected to non-Medtronic leads, as identified and monitored remotely via the Medtronic CareLink Network. This includes approximately 5,100 Endotak leads, 6,100 Riata/Durata leads from St. Jude Medical and nearly 500 leads from other manufacturers, including Biotronik. An external panel of physicians who had access to device-stored electrograms and the clinical interpretation of the treating physician adjudicated non-Medtronic lead issues identified by LIA.
 
"We've seen the effectiveness of the LIA software with Medtronic devices and leads these past four years, and we know it can have an impact beyond our leads," said Marshall Stanton, M.D., vice president, Medtronic. "LIA detects lead failures better than impedance alone and this approval provides implanting physicians with performance information on this advanced decision-making tool to benefit the health and well-being of their patients."
 
LIA is included in the SmartShock suite of algorithms that yields the lowest occurrence rate of inappropriate shocks for any defibrillator in the industry. [i] [ii]
 
For more information: www.medtronic.com
 
References:
[i] Schloss EJ, et al. PainFree SST Trial Primary Results:  Low Shock Rates in Patients with Dual and Triple Chamber ICDs Using Novel Detection Algorithms. Heart Rhythm. 2013;10(50):S64.
[ii] Schloss E, et al. PainFree SmartShock technology: trial primary results: inappropriate shock rates in patients with single chamber ICD's using a novel suite of detection algorithms. EHRA Europace 2013 Late Breaking Trial session 1. 
 

Related Content

Smartphone Apps Help Patients and Providers Manage Atrial Fibrillation
News | Patient Engagement| October 19, 2017
October 19, 2017 — Novel smartphone and tablet applications for atrial fibrillation patients and healthcare professio
The Respicardia Remede System is a pacemaker-like device designed to improve cardiovascular health by restoring natural breathing during sleep in patients with Central sleep apnea.
Technology | Heart Failure| October 18, 2017
October 18, 2017 — The U.S.
Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab| October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
CardioFocus Announces European CE Mark Approval of HeartLight Excalibur Balloon
Technology | Ablation Systems| October 10, 2017
October 10, 2017 — CardioFocus Inc. recently announced the European CE Mark approval of the HeartLight Excalibur Ball
The Apama Radiofrequency (RF) Balloon Catheter System.
News | Ablation Systems| October 02, 2017
October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held
Boston Scientific Launches Resonate Devices With HeartLogic Heart Failure Diagnostic
Technology | Implantable Cardioverter Defibrillator (ICD)| September 27, 2017
September 27, 2017 — Boston Scientific recently launched the Resonate family of...
Spectranetics Initiates Class I Recall for Bridge Occlusion Balloon Catheter
News | EP Lab| September 27, 2017
Spectranetics is recalling its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in...
Abbott Secures FDA Approval for MRI Compatibility on Ellipse ICD
Technology | Implantable Cardioverter Defibrillator (ICD)| September 22, 2017
Abbott announced U.S. Food and Drug Administration (FDA) approval for magnetic resonance (MR)-conditional labeling for...
Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Overlay Init