Biotronik, a leading manufacturer of cardiovascular medical technology, has announced the Japanese market release of its ProMRI Iforia 7 DR-T and VR-T DF4 implantable cardiac defibrillators (ICDs). 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 the now common three-in-one DF4 lead connector system. The single-chamber Iforia 7 is one of the smallest cardiac implants on the market, yet it still 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. The small size of the device makes it more comfortable for the patient and leads to a better cosmetic result.
“Although MR 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,” commented Dr Koichi Inoue, Cardiovascular Center, Sakurabashi Watanabe Hospital, Osaka, Japan. He added: “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 level, Iforia 7 works with Home Monitoring, which would address the possibility of human error by alerting the physician if the device is not returned to its correct settings after an 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 per cent 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 is therefore a huge advantage for ICD patients and their physicians.
“Cardiac device patients and physicians have long expressed a clear need for devices that are safe to undergo MRI scans,” commented Jeffrey Annis, managing director Biotronik Japan. “We have been answering this call by producing the world’s largest 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 per cent. We are proud that these excellent devices are now available in Japan: a country that embraces sophisticated and beneficial technology.”
Biotronik ProMRI technology enables patients with a pacemaker, implantable defibrillator, or cardiac resynchronization therapy defibrillator (CRT-D) or pacemaker (CRT-P) to undergo an MRI scan. Biotronik has the broadest portfolio of cardiac devices approved for use with MRIs on the market and is the only company to allow heart failure patients with CRT devices to take advantage of MRI scans. ProMRI technology enables pacemaker patients, and now ICD patients, to undergo full-body 1.5 tesla scans.
One of the world's leading manufacturers of cardio and endovascular medical devices, Biotronik is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees.