BERLIN--(BUSINESS WIRE)--BIOTRONIK SE & Co. KG, a worldwide leader in manufacturing cardiac medical devices, announced today that the innovative new Lumax 540 VR-T DX single-chamber implantable cardiac defibrillator (ICD) and Linox^smart S DX cardiac lead system will be launched this coming week at the EHRA EUROPACE electrophysiology congress in Madrid, Spain. The Lumax DX system uniquely expands the diagnostic capabilities of the standard single-chamber ICD by integrating special atrial sensors and advanced discrimination algorithms.

The Lumax DX serves a previously unmet need for cardiac device patients who are candidates for a single-chamber ICD. Standard single-chamber ICDs are designed only to sense changes in ventricular rhythm and are unable to correctly sense atrial arrhythmias such as atrial fibrillation (AF) correctly, which increases the risk of inappropriate shock or could potentially result in the patient having a stroke.

“Studies have demonstrated that the lifetime risk of developing AF is 25% in people who have reached the age of 40. Furthermore, out of all ICD and pacemaker patients, it has been shown that more than 13% have a previously unknown AF,” commented Dr. med. Alexander Schirdewan, Charité University Hospital, Campus Benjamin Franklin, Berlin, Germany. “Stroke is one of the most serious risks of AF and furthermore, out of all shocks that are delivered to ICD patients, 76% are caused by the ICD misinterpreting the fast atrial arrhythmias as ventricular events. The Lumax DX system combined with BIOTRONIK Home Monitoring^® is the only single-chamber ICD available that can avoid these risks by appropriately detecting atrial arrhythmias and immediately enabling physicians to intervene.”

Signals coming from the atrial chambers of a patient’s heart can now be sensed by the floating atrial dipole of the Linox^smart S DX ICD lead and are amplified by a modified atrial input stage of the Lumax 540 VR-T DX device. The complementary atrial information ensures accurate sensing capabilities and provides unique protection for single-chamber ICD patients.

Enhanced arrhythmia diagnosis. Unlike standard single-chamber ICDs, the Lumax DX system provides atrial electrograms in addition to the standard ventricular ones. The physician is able to use recordings of a three-channel IEGM, showing atrial, ventricular and far-field signals in high resolution to better determine the origin of the tachycardia and to increase treatment efficiency.

Safe shock reduction. Because standard single-chamber ICDs use only ventricular information and ignore atrial events to make therapy decisions, they may misclassify these as ventricular tachycardias and deliver inappropriate shocks. Lumax 540 VR-T DX can discriminate supraventricular tachycardias (SVTs), atrial fibrillation and atrial flutter with its SMART Detection^® algorithm, helping to safely reduce this risk.

Optimized AF management. BIOTRONIK Home Monitoring^® is the world’s most proven and advanced cardiac remote monitoring system, allowing physicians to remotely follow their Lumax 540 VR-T DX patients’ clinical and device statuses at any time from anywhere in the world. In addition to the usual ventricular information of their single-chamber ICD patients, they now have access to complete AF and heart failure (HF) diagnostic data, which significantly improves early detection for reduced risk of stroke.

“BIOTRONIK is known worldwide for its superior cardiac lead technology, a core competency that has allowed us to create the innovative floating atrial dipole of the Linox^smart S DX ICD lead,” commented Marlou Janssen, Global Vice President of Marketing and Sales at BIOTRONIK. “Combined with our proprietary algorithms, high quality Lumax 540 devices and the unique advantage of early detection with BIOTRONIK Home Monitoring^®, we are able to offer physicians the industry’s most comprehensive and safe solutions for single-chamber ICD patients.”

References for Dr. Schirdewan’s quote:

Camm, AJ et al., Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation, Europace, 11(1):54–61, 2009.

Daubert, JP et al., Inappropriate implantable cardioverter-defibrillator shocks in MADIT-II, JACC, 51:1357–65, 2008

Ricci, RP et al., Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC), Europace, 12(10):1360–1420, 2010.

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 5,600 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.

More information: www.biotronik.com

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