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

CardioKinetix, Parachute device, Heart Failure device therapy

The CardioKinetix Parachute device implant shown deployed in the left ventricle of a heart failure patient. The device helps remodel the ventricle to improve the heart's ability to pump blood more efficiently. 

Feature | Heart Failure| September 29, 2016 | Abha Mishra
New cardiovascular device therapies for atrial fibrillation (AF) and heart failure (HF) are rapidly evolving with the
Infinix 4D CT

Toshiba's Infinix 4D CT, which combines CT with angiography in the interventional lab.

Feature | Angiography| September 28, 2016 | Tom Watson BS, RCVT, Clinical Analyst, MD Buyline
One of the more significant advancements for interventional X-ray (IXR) in the past few years has been a significantl
European Heart Rhythm Association, EHRA White Book 2016, EP Europace supplement, cardiac rhythm device use, Europe
News | EP Lab| September 27, 2016
In August, the European Heart Rhythm Association (EHRA) and EP Europace journal announced the release of the supplement...
Sponsored Content | Videos | Inventory Management| September 21, 2016
With bundled payments putting increased pressure on hospitals to manage supply costs while providing quality patient
Medtronic, CRT, cardiac resynchroniazation therapy devices, heart failure, medication adherence, retrospective analysis, HFSA 2016
News | Heart Failure| September 20, 2016
Medtronic plc announced the results of an analysis that reveals patients increasingly adhere to heart failure...
don woodlock, GE Healthcare, EP CVIS, electrophyiology
Sponsored Content | Webinar | Cardiac PACS| September 16, 2016
Cardiac rhythm management (CRM) data is becoming increasingly important in the management of patients with implantabl
EBR Systems, FDA, WiSE Technology, Wireless Stimulation Endocardially, SOLVE-CRT study

The WiSE CRT System uses a tiny implant in the left ventricle to synchronize the heart, overcoming limitations of traditional cardiac resynchronization therapy (CRT) in heart failure patients. Graphic courtesy of Business Wire.

News | Cardiac Resynchronization Therapy Devices (CRT)| September 15, 2016
EBR Systems Inc. announced the U.S. Food and Drug Administration (FDA) has granted an Investigational Device Exemption...
Sponsored Content | Videos | Heart Failure| September 02, 2016
The Respicardia Remede System is a pacemaker-like implantable device designed to improve cardiovascular health by res
Respicardia, Remede, pacemaker for sleep apnea, central sleep apnea treatment

The Respicardia Remede System is a pacemaker-like implantable device designed to improve cardiovascular health by restoring natural breathing during sleep in patients with central sleep apnea.

News | Heart Failure| September 02, 2016
September 2, 2016 — Results from an international, randomized study show that an implanted nerve stimulator significa
Overlay Init