St. Jude Medical won approval in Japan for the 1st commercially available pacemaker and lead system deemed safe during a full-body, high-resolution MRI.
Japanese regulators cleared St. Jude Medical‘s (NYSE:STJ) MRI-safe pacemaker and lead devices, the 1st such devices commercially available there, according to the medical device company.
The devices, the Accent MRI pacemaker and Tendril MRI lead, will remain safely implanted even during a full-body MRI scan, according to a press release.
St. Paul., Minn.-based St. Jude said it designed the pacemaker and lead system with an "activator" device, a handheld remote used to wirelessly switch the implant to an MRI-safe mode.
The Accent pacemaker comes in 2 models, 1 that monitors the heart’s upper chambers and 1 that monitors the lower right chamber, according to the release. The company touts its Merlin patient network, used to control the devices, as a safe and secure remote monitoring system.
"The Accent MRI pacemaker has many advantages over what is currently available for patients. The sophisticated pacemaker functionality and labeling of full-body MRI scans are especially important for patients who may need an MRI scan in the chest and abdominal area. We are excited to offer this innovative technology to hospitals throughout Japan," William Phillips, St. Jude’s senior vice president for Asia, said in prepared remarks.
The company won CE Mark approval for Accent and Tendril in 2011, gaining on the lead its Twin Cities competitor Medtronic (NYSE:MDT) established with its Revo MRI-safe system.
*Correction, June 28, 2013: This article originally stated that St. Jude’s product was the 1st MRI-safe pacemaker and lead. Return to the corrected sentence.
