World’s Only Company to Offer Japan’s ICD and Pacemaker Patients 3 Tesla MRI Access

Japanese Release of Eluna 8 Pacemaker Makes BIOTRONIK the Only Company Allowing Both Pacemaker and ICD Patients Access to 3 Tesla MRI Scans in Japan

TOKYO, Japan, December 1, 2015 – BIOTRONIK, the world’s leading manufacturer of MR conditional cardiac devices, has announced that its Eluna 8 pacemaker is now available in Japan. The pacemaker is approved for 1.5 tesla (T) full-body MRI scans, and ultra-high strength 3.0 T MRI scans with an exclusion zone.

In October, the German company announced the Japanese market release of their Iperia ICD—the lone ICD approved for 3 T MRI scanning in Japan. Thus, BIOTRONIK is the only company to provide cardiac patients in Japan with both ICDs and pacemakers that are proven safe for 3 T MRI scanning. This makes possible the long desired, yet inaccessible, gold standard in soft tissue imaging for cardiac implantable electronic device patients.

Dr. Satoki Fuji from Kurashiki Central Hospital commented: “Recently MR conditional devices have become the gold standard for pacemaker implantations. Devices which are approved for both 3.0 T and 1.5 T scans will be expected not only by patients but also preferred by radiologists and others who will be following the patient. 3 T scanning brings shorter scanning times, higher quality images and a variety of additional functionality. In terms of the overall patient benefit, implanting physicians should carefully consider these devices during implant selection.”

Dr. Hajime Nakamura, a brain surgeon at Osaka University Hospital added: "For the cranial nerve area, a brain MRI scan is absolutely imperative. It is very effective for the detection of cerebral artery aneurysm, arteriolar sclerotic changes of cerebral vascular, and occurrences of micro brain infarction and brain hemorrhaging. A detailed image assessment for these lesions with 3 T MRI makes it possible to provide tailor-made medicine and reduce brain surgery complications. I hope more patients will receive these devices in order to have access to the most advanced cranial nerve and cerebral medical care available."

The Eluna comes in both single- and dual-chamber models and as well as being MR conditional, offers a string of other benefits. It is compatible with the BIOTRONIK Home Monitoring® system, which provides physicians with a way to monitor their patients, as well as the implants, remotely and with ease. This has been shown to reduce hospitalization for atrial arrhythmias and related stroke by 66 percent in the COMPAS trial.1 It also features a wandless radio frequency (RF) telemetry for efficient device programming and interrogation at implant, a physiologic rate adjustment available via Closed Loop Stimulation (CLS), and thoracic impedance (TI) diagnostics to provide vital information on heart failure progression.

With BIOTRONIK’s increasing presence in Japan, Jeffrey Annis, Managing Director BIOTRONIK Japan, reminds physicians of the company’s full portfolio of MR conditional devices, a claim that only the German manufacturer can make.

He added: “Heart disease is the second most prominent cause of mortality in Japan and we at BIOTRONIK are committed to saving lives of those affected by it. By opening up full-body MRI scanning possibilities for device patients in Japan, and allowing 3T scanning with an exclusion zone, I am confident it will make a considerable difference in patients’ lives. The prevalence of 3 T MRI machines is on the rise in Japan, and we want to make sure that our device patients are not excluded if they should require this superior diagnostic tool.”

  1. Mabo P et al. COMPAS Trial, European Heart Journal 2011.