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

ICDs, non-ischemic cardiomyopathy, University of Alabama at Birmingham study, Circulation
News | Implantable Cardioverter Defibrillators (ICD)| January 18, 2017
A new study published in Circulation has found there is a 23 percent risk in reduction of all-cause mortality in non-...
LindaCare, expansion, remote patient monitoring, CIEDs, cardiac implantable electronic devices, United States
News | Remote Monitoring| January 18, 2017
LindaCare announced that it will open a new customer support facility in Connecticut to support growing interest in...
ICDs, implantable cardioverter defibrillators, survival rate, elderly patients, JACC study
News | Implantable Cardioverter Defibrillators (ICD)| January 17, 2017
Of patients over age 65 who received an implantable cardioverter-defibrillator (ICD) after surviving sudden cardiac...
St. Jude Medical, Amplatzer Amulet LAA Occluder, observational study, TCT 2016
News | Left Atrial Appendage (LAA) Occluders| November 03, 2016
St. Jude Medical Inc. presented favorable results from the largest observational study to date of the company’s...
RFID inventory control in the cath lab, inventory management, cardinal

An example of RFID cabinets in a cath lab. As items are pulled from the cabinet, the inventory control system automatically determines what items were take out and adds them to the patient case. The system can also help locate recalled or expired items, and automatically track on-hand inventory to avoid manual counts.

Feature | Inventory Management| October 28, 2016 | Jean-Claude Saghbini
The healthcare industry’s transition to value-based care leaves no room for waste, and yet we know that inefficiency
Sponsored Content | Videos | Sudden Cardiac Arrest| October 28, 2016
It is critical to educate patients who are at risk of sudden cardiac arrest (SCA), so Rahul Doshi, M.D., director of
Sponsored Content | Videos | Inventory Management| October 28, 2016
With quality of care and cost efficiency at the top of your mind, there is no room in your hospital for waste from hi
Acutus Medical, AcQMap High Resolution Imaging and Mapping System, atrial fibrillation, UNCOVER-AF trial, first procedure
News | EP Mapping and Imaging Systems| October 27, 2016
Acutus Medical announced the completion of the first patient procedure in the “Utilizing Novel Dipole Density...
BioTrace Medical Tempo temporary pacing lead, TAVR
Technology | Heart Valve Technology| October 27, 2016
October 27, 2016 — BioTrace Medical Inc. said it received U.S.
Niobe remote magnetic navigation system, cardiac abltion, Robert Wood Johnson University Hospital, New Jersey, 500 procedures
News | Robotic Systems| October 25, 2016
Stereotaxis Inc. and Robert Wood Johnson University Hospital (RWJUH) announced that Zyad Younan, M.D., has completed...
Overlay Init