Press release

Lumax 540 VR-T DX ICD and Linoxsmart S DX lead for unique patient protection with optimal AF management and efficient shock reduction

BERLIN, Germany, March 24, 2010 - BIOTRONIK SE & Co. KG, a leading manufacturer of implantable cardiac devices and pioneer of wireless remote monitoring technologies, today announced the first implantations of the Lumax DX System, a novel single-chamber ICD concept.

The Lumax 540 VR-T DX single-chamber ICD and the specially designed Linoxsmart S DX right ventricular lead with floating atrial dipole provide 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.
 

World’s first and only single-chamber ICD designed for early detection and diagnosis of AF

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 from the Charité Campus Benjamin Franklin in Berlin, Germany, Coordinating Clinical Investigator of the Linoxsmart S DX master study, after the first implantation on March 18.

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 and ensure 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 Prof. Dr. Antonio Curnis from Spedali Civili in Brescia, at the University of Brescia in Italy after the first implantation of the DX system on March 16.

Prof. Dr. 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

Combined with the clinically proven, fully mobile BIOTRONIK Home Monitoring®, Lumax 540 VR-T DX 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

 

BIOTRONIK continues to provide highest-quality Cardiac Rhythm Management solutions

Both the Lumax 540 VR-T DX and Linoxsmart S DX rely on proven technology platforms, representing BIOTRONIK’s continuing commitment to provide the highest-quality solutions for advanced management of cardiovascular diseases.

“BIOTRONIK once again sets standards in the diagnosis and treatment of atrial fibrillation,” stated Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management at BIOTRONIK. “This innovative system completes our Lumax 540 series of premium ICDs, addressing unmet clinical needs in the treatment of AF. It also helps to avoid inappropriate ICD therapies by providing unique patient protection with a single-chamber ICD. I would like to thank Mr. Roberto Belke, Vice President Marketing & Sales Central, Northern & South Eastern Europe at BIOTRONIK, who initiated this unique concept in close cooperation with clinical experts.”'
 

Acknowledgment

BIOTRONIK would like to extend its sincere thanks to the physicians who participated in the world’s first implantations of the Lumax 540 VR-T DX and Linoxsmart S DX:

Dr. med. Alexander Schirdewan, Dr. med. Erdal Safak, Charité - Campus Benjamin Franklin, Berlin, Germany

Prof. Dr. Antonio Curnis, Spedali Civili di Brescia, Brescia, Italy

Prof. Dr. med. Hubertus Heuer, Dr. med. Ralf Dedner, St. Johannes Hospital, Dortmund, Germany

Prim. Dr. Harald Mayr, Zentralklinikum St. Pölten, St. Pölten, Austria

Prof. Dr. Béla Merkely, Semmelweis University, Budapest, Hungary

Prof. Dr. med. Christian Sticherling, Universitätsspital Basel, Basel, Switzerland

 

About atrial fibrillation

Atrial fibrillation is a supraventricular tachyarrhythmia characterized by uncoordinated atrial activation. It is the most common arrhythmia in clinical practice, accounting for approximately one-third of hospitalizations for cardiac rhythm disturbances, and is associated with an increased long-term risk of stroke, heart failure, and all-cause mortality.3 In addition, atrial fibrillation is a main cause of inappropriate ICD therapies resulting from misclassification as ventricular tachycardia which requires immediate ICD therapy by anti-tachycardia pacing or high-energy shocks.4
 

About BIOTRONIK SE & Co. KG

As one of the world’s leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of over 5,100 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.


1Single 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.
3ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation.

4J. Daubert, W. Zareba, D. Cannom, et al. Inappropriate implantable cardioverter-defibrillator shocks in MAD IT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008;51:1357–65.

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