Biotronik’s Eluna 8 MRI-safe pacer hits the market in Japan

Biotronik yesterday said that its Eluna 8 MRI-safe pacemaker hit the market in Japan, for 1.5-tesla full-body scans and conditional 3T scans.

“Heart disease is the 2nd-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,” Biotronik Japan managing director Jeffrey Annis said in prepared remarks.

“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,” added Dr. Satoki Fuji of the Kurashiki Central Hospital.

“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,” noted Dr. Hajime Nakamura, a brain surgeon at Osaka University Hospital.

Biotronik said yesterday that it enrolled the 1st patient in its B3 trial examining the company’s Closed Loop Stimulation physiologic rate response sensor and algorithm.

In July, Biotronik said it won FDA premarket approval for its quadripolar Itrevia HF-T cardiac resynchronization defibrillator with CLS and launched the device in the U.S. market.

The Itrevia is approved for use with IS4 compatible left ventricular leads, the German medical device giant said. The 1st patients have already been implanted with the device, the company added.

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