Germany-based Biotronik has received approval from the US Food and Drug Administration (FDA) for its ProMRI Eluna pacemaker system.
According to the company, the ProMRI technology permits patients to undergo full-body magnetic resonance imaging (MRI) scans with both single-chamber (SR-T) and dual-chamber (DR-T) Eluna pacemakers when implanted with Setrox pacing leads.
Biotronik sales and marketing executive president Paul Woodstock said: "We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems.
"Biotronik’s latest device and ProMRI technology ensure that patients – and their physicians – will have the best diagnostic options available."
Biotronik Home Monitoring is available with Eluna pacemakers, which allows physicians in early detection of clinical episodes and device events.
MRI is said to enhance diagnostic capabilities for multiple medical conditions such as chronic neck or lower back pain, soft tissue masses and stroke symptoms, which are not adequately examined by X-ray or computerized tomography (CT).
Biotronik, which has operations in around 100 countries, manufactures cardio and endovascular medical devices.