Cardiovascular technology company Biotronik has gained CE mark approval for its advanced ICD/CRT-D (cardioverter-defibrillator/cardiac resynchronization therapy defibrillator) series.
Iforia is the world’s first DF4 ICD/CRT-D series to be approved for MRI (magnetic resonance imaging). In addition it contains one of the world’s smallest ICDs– the Iforia single chamber ICD.
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 which Biotronik points out is a clear benefit for both patients and the health care system.
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.
European market release of the Iforia series is expected in midyear 2013.
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.”
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.”