News | March 26, 2010

First Implantations Made With Single-Chamber ICD With Full Atrial Diagnostics

March 26, 2010 – The first implantations were announced yesterday for a single-chamber implantable cardioverter defibrillator. The system provides physicians with complete diagnostic information not only from the right ventricle, as in regular single-chamber ICDs, but also from the right atrium, including high-resolution online IEGMs.

The additional atrial information can be used for advanced discrimination of supraventricular tachycardias (SVTs) to avoid inappropriate ICD shock therapies and for diagnostic purposes for early detection of atrial arrhythmias, including atrial fibrillation (AF), to reduce the risk of stroke.

After receiving the CE mark, the first Lumax DX Systems were successfully implanted simultaneously at six hospitals across Europe during the third week of March.

The unique Lumax DX System provides patients at risk of sudden cardiac death with a single-chamber ICD system that provides protection and reduces risk.

“The immediate information about atrial arrhythmias, even when asymptomatic, allows me to detect and treat AF early and minimize associated risks such as inappropriate therapies and stroke. Also, I can monitor the success of my AF therapies remotely with Biotronik Home Monitoring and contact the patient whenever needed,” said Dr. Alexander Schirdewan, Charité Campus Benjamin Franklin in Berlin, Germany, and coordinating clinical investigator of the Linoxsmart S DX master study.

Lumax 540 VR-T DX uses the advanced Biotronik Smart Detection algorithm that analyzes the ventricular as well as the atrial heart rate to appropriately discriminate supraventricular tachycardias from ventricular tachycardias and thereby reduce the number of inappropriate therapies, ensuring that a shock is only delivered when absolutely required.

“So far, single-chamber ICDs were limited to ventricular information for the discrimination of SVTs. The SMART algorithm also uses the additional information from the atrium and has proven reliable sensitivity and high specificity in dual-chamber ICDs, and now I can offer this technology to my single-chamber ICD patients too,” said Dr. Antonio Curnis from Spedali Civili in Brescia, professor at the University of Brescia in Italy after the first implantation of the DX system on March 16.

Curnis was the principal investigator of the Italian ADAMO registry that already proved the high sensitivity and specificity of the smart algorithm in a similar Biotronik ICD system.(1)

According to a company press release, Lumax 540 VR-T DX, combined with the fully mobile Biotronik Home Monitoring, is the world’s first and only single-chamber ICD which wirelessly transmits all required patient and device data, including IEGM Online HD for early detection of ventricular and atrial rate disorders and to perform complete remote follow-ups.(2)

Both the Lumax 540 VR-T DX and Linoxsmart S DX rely on proven technology platforms.

For more information:

1. "Single Chamber ICD with Single-Pass AV Defibrillation Lead. Outcomes of the ADAMO Italian Registry." PACE 2006; Vol. 29, Supplement 1.
2 N. Varma et al. "Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial." Circulation 2008;118;2309-2317, Abstract 4078.
3 ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation.
4. J. Daubert, W. Zareba, D. Cannom, et al. "Inappropriate implantable cardioverter-defibrillator shocks in MAD IT II: frequency, mechanisms, predictors, and survival impact." Journal of the American College Cardiology 2008;51:1357–65.

Related Content

Medtronic Begins Pilot Study of Investigational Extravascular ICD System
News | Implantable Cardioverter Defibrillator (ICD) | August 09, 2018
Medtronic plc announced the start of a pilot study of its investigational Extravascular Implantable Cardioverter...
ICD Placements Not Meeting Medicare Coverage Criteria Decline After Overuse Investigation Announced
Feature | Implantable Cardioverter Defibrillator (ICD) | July 11, 2018
Placement of implantable cardioverter defibrillators (ICDs) not meeting Centers for Medicare and Medicaid Services (CMS...
New Tool Predicts Benefits and Risks of Implantable Defibrillator for Heart Failure Patients
News | Implantable Cardioverter Defibrillator (ICD) | July 02, 2018
University of Washington (UW) Medicine cardiologists have developed a tool to predict which heart-failure patients...
Real-World Data Demonstrates Success Of Smart Pass Filter on Boston Scientific S-ICD System
News | Implantable Cardioverter Defibrillator (ICD) | May 16, 2018
Boston Scientific announced results from an analysis of the LATITUDE database evaluating the successful reduction of...
Online Message Board Advice on ICDs Reflects Inaccuracies
News | Implantable Cardioverter Defibrillator (ICD) | April 13, 2018
April 13, 2018 — Medical advice about implanted cardiac defibrillators obtained via an online message board appears t
Biotronik U.S. to Distribute Aziyo ECM Envelopes
News | Implantable Cardioverter Defibrillator (ICD) | April 12, 2018
Biotronik U.S. and Aziyo announced a strategic agreement allowing Biotronik to distribute Aziyo's CanGaroo...
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...
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...
Predictive Models May Help Determine Which Patients Benefit From ICDs
News | Implantable Cardioverter Defibrillator (ICD) | July 06, 2017
Two predictive models may help cardiologists decide which patients would most benefit from an implantable cardioverter...
Videos | Implantable Cardioverter Defibrillator (ICD) | June 01, 2017
Lucas Boersma, M.D., Ph.D., FESC, St.
Overlay Init