Biotronik Launches Iforia 7 DR-T in Japan

Biotronik SE & Co. Kg has launched its ProMRI Iforia 7 DR-T and VR-T DF4 implantable cardiac defibrillators (ICDs) in Japan. The dual- and single-chamber Iforia 7 ICDs offer patients full-body MRI scans at standard 1.5 tesla scan strength.

Biotronik’s Iforia 7 ICDs use a three-in-one DF4 lead connector system, according to a company news release. The single-chamber Iforia 7 is one of the smallest cardiac implants on the market, yet it features Biotronik home monitoring technology, which transmits patient medical data and device status on a daily basis, enabling the respective physician to adapt therapy solutions at a very early stage. In addition, the DF4 technology simplifies the implantation procedure, company executives said. The small size of the device makes it more comfortable for the patient and leads to a better cosmetic result.

“Although MR [magnetic resonance] conditional ICDs have already been approved, some previous models came with limitations in terms of testing conditions as well as the area allowed for MRI scanning,” said Koichi Inoue, M.D., Ph.D., with the Cardiovascular Center at Sakurabashi Watanabe Hospital in Osaka, Japan. “The new Iforia 7 ICDs have no limitation for the scanning area, and a range of Biotronik MR conditional cardiovascular implantable electronic devices are now offered, which have fewer testing conditions than before. This is a welcome progression for both patients and physicians.”

Also, as an added safety, Iforia 7 works with home monitoring technology, which would address the possibility of human error by alerting the physician if the device is not returned to its correct settings after an magnetic resonance imaging (MRI) scan.

MRI scans have long been the first choice in diagnostics, particularly in soft-tissue imaging, and Japan is the world’s largest user of MRI technology. Recent studies estimate 50 to 75 percent of heart failure patients will develop a clinical need for an MRI scan over the course of their lifetime. Having a device that is MRI conditional, therefore, is a significant advantage for ICD patients and physicians.

“Cardiac device patients and physicians have long expressed a clear need for devices that are safe to undergo MRI scans,” noted Jeffrey Annis, managing director of Biotronik Japan. “We have been answering this call by producing a portfolio of ProMRI devices. They also come with Biotronik home monitoring, which was demonstrated in the In-Time trial to reduce mortality by more than 50 percent. We are proud that these excellent devices are now available in Japan: a country that embraces sophisticated and beneficial technology.”

Biotronik is headquartered in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.