June 20, 2013 06:29 ET

Market Launch of the BIOTRONIK Ilesto 7 Series -- World's First DF4 ICD/CRT-D Series Approved for MR Scans

BERLIN--(Marketwired - Jun 20, 2013) - BIOTRONIK, the leading manufacturer of cardiovascular medical technology celebrating its 50th anniversary this year, announced the European market launch of its Ilesto 7 Series today. Ilesto 7 is the world's first DF4 ICD/CRT series approved for MRI, and includes one of the world's smallest ICDs while also offering the greatest longevity -- up to 11.5 years for the single chamber ICD.

"We see a rising need for MR scans at our clinic and nationwide, and we acknowledge the steps BIOTRONIK has taken to develop its ProMRI® technology in order to help thousands of patients obtain the diagnostics they desperately need," explains Dr. Juan Gabriel Martinez, Head of the Arrhythmia Unit of Hospital General Alicante, Spain.

Dr. Martinez implanted an Ilesto 7 HF-T in a 63-year-old patient suffering from cardiomyopathy. "Before BIOTRONIK launched its ProMRI® technology, patients with an ICD or CRT-D were prohibited from undergoing MR scans. Fortunately, with the new Ilesto system, I can offer my patients the option of an MR scan if they need one in the future. This is a very important aspect to my patients, as they have a high chance of needing an MR scan during the lifetime of their devices."

Different statistics show a rising need for MR scanning among CIED patients. The number of patients with ICDs continues to grow by 10 to 15 percent annually, and an estimated 50 to 75 percent of these patients will need an MR scan during the service lives of their devices.1 As patients live longer and frequently suffer comorbidities, a further increase is certain in the coming years.

With its new Ilesto 7 Series and existing Lumax 740 ICD/CRT-D series, released in the European market in April 2012, BIOTRONIK offers the world's only two ICD/CRT-D series approved for MR scanning.

Due to its small size, the Ilesto 7 Series and the new DF4 connector system simplifies and shortens the implantation procedure, is more comfortable for the patient, and also leads to better cosmetic results.

Patients also benefit from secure remote monitoring via BIOTRONIK Home Monitoring®, a unique feature that offers both patients and physicians the ultimate convenience: it does not require any patient interaction. BIOTRONIK Home Monitoring® is the first and only wireless remote system with both FDA and CE approval for early detection of clinically relevant events and reduction of in-office follow-ups.

"With all our innovations, patient safety comes first," notes Christoph Böhmer, President International of BIOTRONIK. "Our patients have the peace of mind that their device and thus their cardiac health is constantly being monitored through BIOTRONIK Home Monitoring®. In addition, Home Monitoring guided therapy has been shown to enable significant reduction of delivered shocks by 71%, as well as a reduction in hospitalization due to avoidance of inappropriate shocks by 73%."2

As one of the world's leading manufacturers of cardiovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million heart patients around the world have received BIOTRONIK implants, designed to save and improve the quality of their lives. Since its development of the first German pacemaker in 1963, BIOTRONIK has launched several innovations into the market--including remote monitoring with BIOTRONIK Home Monitoring® in 2000 and the world's first implantable cardioverter-defibrillators and implantable heart failure therapy devices with ProMRI® technology, approved for MR scanning, in 2012. This year BIOTRONIK is celebrating its 50th anniversary.

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1 Roguin et al., Europace 2008, 10, 336-346.
2Guédon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS, Aliot E, Boursier M, Bizeau O, Kacet S, A randomized study of remote follow-up of implantable defibrillators, Safety and efficacy report of the ECOST trial, Eur Heart J (2013) 34, 605-614.

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