On 26 March, Biotronik announced it has gained the CE mark approval for its Iforia ICD/CRT-D (cardioverter-defibrillator/cardiac resynchronisation therapy defibrillator) series. According to a company release, Iforia is the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, the company release stated, it contains one of the world’s smallest ICDs the Iforia single chamber ICD.
Iforia features ProMRI technology, which allows patients to undergo potentially life-saving MRI scans. The device 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.
The Iforia single chamber ICD has longevity of more than 11 years and the Iforia CRT-D of more than seven years. This allows for a low replacement rate.
“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,” said Ching Chi Keong, National Heart Centre Singapore, and one of the first implanters.
“Safety and reliability are the foundation of all of our new technologies and innovations,” said Christoph Böhmer, president Biotronik International. “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.”
The European market release of the Iforia series is expected in midyear 2013, the company announced.
First Implanters of the Iforia series
Steffen Behrens, Vivantes Humboldt Hospital Berlin, Germany;
Ching Chi Keong, National Heart Centre Singapore, Singapore;
Thomas Faber, University Heart Centre Freiburg, Germany;
Stephan B Felix and Mathias Busch, University Hospital Greifswald, Germany;
Peter Lercher and Günther Prenner, LKH-University Clinic Graz, Austria;
Abdulmohsen al Musaad, National Guard Health Affairs Hospital, Riyadh, Saudi Arabia;
Antti Ylitalo and Tuomas Paana, Satakunta Central Hospital, Pori, Finland.