Medtronic receives FDA and CE approval for cardiac monitor

Medtronic has received Food and Drug Administration (FDA) clearance and CE mark approval for its LINQ II insertable cardiac monitor (ICM) with remote programming. 

The device enables clinicians to optimise device settings without the need for patients to return to the office or hospital.

The LINQ II system aims to last 4.5 years and deliver enhanced accuracy to correctly detect abnormal heart rhythms.

LINQ II is a small (one-third the size of a AAA battery), wireless ICM for patients with abnormal heart rhythms who experience infrequent symptoms including dizziness, palpitations, syncope (fainting) and chest pain, thereby requiring long-term monitoring or ongoing management. The device will be commercially available in the U.S. and Europe later this summer.

Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division, part of the Cardiac and Vascular Group at Medtronic, said: “In the current COVID-19 environment, the LINQ II system offers patients a seamless way to experience ongoing connectivity between their device and their physician, while reducing the need for in-office visits. LINQ II gives physicians actionable data to help diagnose underlying heart conditions and define treatment protocols for patients with atrial fibrillation (AF) or other abnormal heart rhythms.”

The LINQ II device incorporates many of the features of LINQ with TruRhythm plus improvements.