Medtronic launches Reveal Linq ICM after winning FDA, CE Mark approval

Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance in the US and CE Mark approval in the European Union and launched the device in both regions.

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.

“The Reveal Linq ICM monitor can help patients find answers to problems that may be heart-related without interrupting their lifestyle. The simplified procedure and insertion tools make the device faster and easier for physicians to implant, which may expand access to more patients needing long-term monitoring,” Dr. Rod Passman of Chicago’s Northwestern University Feinberg School of Medicine said in prepared remarks.

“This is a technology that is going to help us reach more patients at risk for cardiac arrhythmias and help healthcare systems more efficiently manage difficult patient populations,” Dr. Randy Lieberman of the Detroit Medical Center said in a prepared statement.

Fridley, Minn.-based Medtronic said that the Reveal Linq ICM is MR-conditional, allowing patients to undergo magnetic resonance imaging if necessary. The system also includes the MyCareLink patient monitor which allows for remote monitoring and the transmission of patient data to clinicians from any location.

“This miniaturized monitoring system is the result of many years of product development work from engineers focused on shrinking the size of medical devices while maintaining their power and improving benefits for patients. This is game-changing technology for patients who need cardiac monitoring, and we look forward to providing them with the most technologically advanced and minimally invasive approach possible,” Medtronic cardiac rhythm disease management biz prez Pat Mackin said in a press release.

Last September, Medtronic launched the Linq device in Japan after winning approval from the Ministry of Health, Labor & Welfare.

Its approval in Japan covers its use for monitoring unexplained syncope and cryptogenic stroke, the company said. Medtronic said the MHLW also granted reimbursement approval for the device.

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