Medtronic receives clearance for insertable cardiac monitor

8 July 2020 (Last Updated July 8th, 2020 11:52)

Medtronic has received clearance for its LINQ II insertable cardiac monitor (ICM) from the Food and Drug Administration (FDA) in the US, as well as CE Mark in Europe.

Medtronic receives clearance for insertable cardiac monitor
Medtronic has made an offer for smaller medical device maker Intersect. Credit: Tony Webster.

Medtronic has received clearance for its LINQ II insertable cardiac monitor (ICM) from the Food and Drug Administration (FDA) in the US, as well as CE Mark in Europe.

LINQ II is a small, wireless ICM for patients with abnormal heart rhythms. These patients require long-term monitoring or continuous management as they experience dizziness, palpitations, syncope (fainting) and chest pain.

The system simplifies diagnosis and monitoring of the patients by providing enhanced accuracy to correctly detect abnormal heart rhythms.

It also eliminates the need for patients to return to the hospital by enabling clinicians to optimise its settings. It is designed to deliver improved device longevity compared to other ICMs.

Medtronic’s Cardiac and Vascular Group cardiac rhythm and heart failure division chief medical officer Rob Kowal 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.”

Medtronic is planning to launch the LINQ IIICM in the US and Europe later this year.

Meanwhile, the company has made an offer for smaller medical device maker Intersect.

California-based Intersect specialises in drug-delivery tools for ear, nose and throat clinicians, treating chronic sinusitis.

According to a report by Bloomberg, Intersect’s board of directors is currently reviewing the offer with its advisers.