BIOTRONIK received FDA approval for its ProMRI Eluna pacemaker, which allows patients with the device to receive full body MRI scans. The regulatory approval applies to both single and dual chamber Eluna devices when using the company’s Setrox pacing leads. This is the first available system that allows patients with single chamber pacing to receive scans of the heart or thoracic cavity.

The Eluna is compatible with BIOTRONIK’s Home Monitoring system, providing cardiologists with a way to monitor their patients, as well as the implants, remotely and with ease. The system is partially automatic, uploading unusual patient events and actions taken by the pacemaker to the company’s servers for physician review.

We want every pacemaker patient to know that they can access MRI scans with our tested and approved systems,” said Paul Woodstock, BIOTRONIK Executive Vice President of Sales and Marketing, in a statement. “BIOTRONIK’s latest device and ProMRI technology ensure that patients – and their physicians – will have the best diagnostic options available.”

source:BIOTRONIK