Simultaneous implantations of BIOTRONIK's Lumax DX single-chamber ICD at six European hospitals

Mar 26 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.

“BIOTRONIK once again sets standards in the diagnosis and treatment of atrial fibrillation”

The Lumax 540 VR-T DX single-chamber ICD and the specially designed Linox^smart 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 Linox^smart 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.

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.