Medtronic (NYSE:MDT) wasted no time in launching its Reveal Linq cardiac monitor in Japan, saying it plans to launch the device there this month now that the device won approval from the Ministry of Health, Labor & Welfare.
The Reveal Linq device is designed to be implanted beneath the skin on the upper left side of the chest for monitoring patients experiencing dizziness, palpitation, fainting or syncope, chest pain and cardiac arrhythmias. Billed as the world’s smallest cardiac monitor, it’s about ⅓ the size of a triple-A battery and is designed to work for 3 years using the company’s CareLink network. Its approval in Japan covers its use for monitoring unexplained syncope and cryptogenic stroke, the company said.
Reveal Linq is also MR-conditional, meaning it’s safe for MRI scans, and wirelessly connects with Medtronic’s CareLink network. Fridley, Minn.-based Medtronic said the MHLW also granted reimbursement approval for the device.
“Medtronic is the pioneer in the miniaturization of medical devices that improve the overall experience for patients,” vice president Nina Goodheart said in prepared remarks. “We are pleased that through our collaboration with MHLW, we can now offer this minimally invasive technology for Japanese patients with syncope and cryptogenic stroke.”