New BIOTRONIK and CRT-D Series Gives Patients First-Ever Access to MR Scans

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BIOTRONIKs ICD and CRT-D Series - Lumax 740

BERLIN--(Marketwire - April 12, 2012) -

BIOTRONIK, a leading manufacturer of innovative medical technology, announced today the European full market release of the new Lumax 740 ICDs (implantable cardiac defibrillators) and CRT-Ds (cardiac resynchronization therapy defibrillators) in the European market. The Lumax 740 is the world’s first and only ICD and CRT-D series approved for magnetic resonance imaging (MRI)(1), now giving ICD and CRT-D patients access to vital MR scans with BIOTRONIK’s innovative ProMRI® technology.

“With its new Lumax 740 series BIOTRONIK is offering physicians and their patients access to state of the art diagnostics and the freedom to select the optimal ICD system for each patient’s indication. The development of the new ProMRI® technology really represents a significant improvement in patient care,” commented Professor Dr. Wilhelm Haverkamp, Charité University Hospital Berlin, Virchow-Clinic Campus, Germany.

Currently patients with standard ICDs are not allowed to have MR scans for safety reasons, yet 50-75% of them will be indicated for an MR scan during the lifetime of their device.(2) Worldwide, the population of patients who need an ICD is growing at a rate of about 10-15% annually. At the same time, the need for MR scans is also increasing at a rate of about 10% each year. Approximately 30 million scans were performed in 2006, and in 2010, there were already about 50 million MR scans conducted worldwide.(3)

MR scanning is the ‘gold standard’ for soft tissue imaging. It is critical for the diagnosis and therapy of serious medical conditions such as cancer and strokes and delivers superior imaging quality and does not expose patients to radiation.

Advanced Patient Therapy
The new BIOTRONIK Lumax 740 series offers not only the world’s first ICDs and CRT-Ds approved for MR scans, but further unique therapy options such as the world’s only single-chamber ICD with complete atrial diagnostics -- the Lumax 740 VR-T DX. Innovative solutions for heart failure patients are integrated in the Lumax 740 HF-T device that enables enhanced CRT effectiveness and includes a new research feature which measures the Intracardiac Impedance (ICI). The new sensor analyzes changes in impedance during the cycle of the heart and is being evaluated in clinical studies. This new feature aims to enhance therapy for heart failure patients in the future.

Broadest portfolio gives access to advanced care
“The Lumax 740 series is a broad portfolio of ICDs, CRT-D devices and leads which enables physicians to choose the best device and lead combination for each patient, along with giving those patients the opportunity for potentially lifesaving MRI procedures,” explains Professor Antonio Curnis, MD, Director Cardiac Pacing and Electrophysiology Lab, University of Brescia, Brescia City Hospital, Italy.

“Because continuous, reliable monitoring is vitally important - especially for those who suffer from heart failure,” continued Professor Curnis, “the Lumax 740 system also integrates a sophisticated remote patient management system. BIOTRONIK Home Monitoring® and the Heart Failure Monitor enhance a patient’s quality of life, and patients know that with these features their physicians can track their conditions remotely. It brings them great peace of mind to know they are being monitored and that any adjustments to their therapies can be made earlier.”

BIOTRONIK Home Monitoring® is the first and only remote patient management system with FDA and CE approvals for safe reduction of in-office follow-ups and for early detection of clinically relevant events. Studies have demonstrated that BIOTRONIK Home Monitoring® enables an early detection of atrial fibrillation and a significant reduction of hospitalizations (COMPAS(4)) and that it also reduces unnecessary and inappropriate shocks (ECOST(5)).

The new Lumax 740 series is part of BIOTRONIK’s technologically advanced tachycardia product portfolio with ProMRI®, which includes 3 ICDs, 1 CRT-D device and 16 leads. The Linoxsmart ICD leads, which have been proven over time to be of the highest quality and reliability, are now approved for MR scanning. In addition to featuring ProMRI® technology, the devices also stand out in the industry because they provide longevities of up to 11 years. Together with its MRI-approved Evia and Estella pacemaker series, BIOTRONIK offers patients the industry’s broadest portfolio of implantable cardiac devices approved for MR scanning.

About BIOTRONIK Home Monitoring®
BIOTRONIK has pioneered advances in its BIOTRONIK Home Monitoring® remote patient management system since its first clinical application in the year 2000. The system is unique because it allows continuous, automatic wireless remote monitoring of patient status and device status with daily updates -- all independent of any patient interaction. The technology leads to earlier intervention, as proven by the results of the TRUST(6,7) landmark trial. Today, BIOTRONIK Home Monitoring® is used extensively in more than 5,300 clinics and 56 countries worldwide.

About ProMRI®
ProMRI® allows patients with a pacemaker, ICD or CRT-D to undergo an MR scan. The BIOTRONIK ProMRI® tachycardia series marks the first time an ICD-/CRT-D portfolio has been designed, tested and approved to make MR scans possible. As a result, physicians have the unique opportunity to select the optimal device from the Lumax 740 series -- offering their patients the most advanced therapy available along with access to MR scans.

About BIOTRONIK SE & Co. KG
As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 5,600 employees. Known for having its fingers 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 and treatment to patient management. Quality, innovation and clinical excellence define BIOTRONIK and its growing success -- and deliver confidence and peace of mind to physicians and their patients worldwide.

For more information: www.biotronik.com

References
(1) For detailed information about ProMRI® including the complete set of conditions and prerequisites please visit www.biotronik.com/promri
(2) Roguin et al., Europace 2008, 10, 336-346.
(3) Morgan Stanley, ICD market, 1996-2009.
(4) Mabo et al., European Heart Journal 2011; doi: 10.1093/eurheartj/ehr419.
(5) Kacet S., presentation at ESC Congress 2011 in Paris, France;
(6) Varma et al., Circulation 2010, 122, 325-332.
(7) Varma et al., Circ Arrhythm Electrophysiol 2010, 3:428-436.