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BIOTRONIK Iforia is the World's First DF4 ICD/CRT-D Series Approved for MRI


3/26/2013 6:43:43 AM

BERLIN--(Marketwire - March 26, 2013) - BIOTRONIK, the leading manufacturer of cardiovascular medical technology celebrating its 50th anniversary this year, gains market approval (CE-approval) for the most advanced ICD/CRT-D (cardioverter-defibrillator/cardiac resynchronization therapy defibrillator) series. Iforia is the world's first DF4 ICD/CRT-D series approved for MRI (magnetic resonance imaging). In addition it contains one of the world's smallest ICDs -- the Iforia single chamber ICD.

Aside from featuring ProMRI® technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.

Ching Chi Keong, MD, National Heart Centre Singapore, one of the first implanters, said, "With the Iforia series I can provide my patients with a small and highly reliable ICD and CRT-D series. It includes an impressive range of state-of-the-art innovations including ProMRI® and home monitoring. In addition the DF4 technology simplifies the implantation procedure, while the small size of the device makes it more comfortable for the patient and also leads to a better cosmetic result."

The Iforia series is one of the smallest ICDs and CRT-Ds on the market, and also offers unsurpassed longevity: The Iforia single chamber ICD has a longevity of more than 11 years and the Iforia CRT-D of more than 7 years. This allows for a low replacement rate -- a clear benefit for both patients and the health care system.

Dr. Mathias Busch explained, "With the ProMRI® technology and BIOTRONIK Home Monitoring® included in the Iforia series my patients have peace of mind, thanks to the device's remote monitoring technology. This tracks their health status from the comfort of their own homes. Moreover, they also have access to potentially life-saving MR scans. Access to these scans is essential since the number of older patients with ICDs is increasing. Many of these patients can also have a significant number of comorbidities that can only be detected using sophisticated MRI technology."

"Safety and reliability are the foundation of all of our new technologies and innovations," said Christoph Böhmer, President International of BIOTRONIK. "Iforia offers enhanced diagnostic possibilities with the highest reliability and unsurpassed longevity."

"BIOTRONIK has consistently driven innovation since its foundation in 1963. In the past 15 months alone, BIOTRONIK received market approval for two series of ICDs and CRT-Ds, both of which enable patients to have access to MR scans. BIOTRONIK is the only company worldwide that offers ICD and CRT-D patients this diagnostic possibility," he continued. "The new Iforia series combined with ProMRI® and BIOTRONIK Home Monitoring®, offers physicians and patients the best combination of reliability and innovation."

European market release of the Iforia series is expected in midyear 2013.

First Implanters of the Iforia series
First implanters of BIOTRONIK's Iforia ICDs and CRT-Ds are:
Prof. Dr. Steffen Behrens, Vivantes Humboldt Hospital Berlin, Germany;
Ching Chi Keong, MD, National Heart Centre Singapore, Singapore;
Dr. Thomas Faber, University Heart Centre Freiburg, Germany;
Prof. Dr. Stephan B. Felix and Dr. Mathias Busch, University Hospital Greifswald, Germany;
Dr. Peter Lercher and Dr. Günther Prenner, LKH-University Clinic Graz, Austria;
Abdulmohsen al Musaad, MD, National Guard Health Affairs Hospital, Riyadh, Saudi Arabia;
Dr. Antti Ylitalo and Dr. Tuomas Paana, Satakunta Central Hospital, Pori, Finland

About BIOTRONIK SE & Co. KG
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.

For more information, visit: www.biotronik.com


Contact:
Manuela Schildwachter
Global Communications Manager
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin
Tel. +49 (0) 30 68905 1466
Email: Email Contact

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