Biotronik wins CE Mark for MRI-safe Ilivia ICD & CRT-Ds

Biotronik said today it won CE Mark approval for its Ilivia ICD and CRT-Ds, which feature the company’s ProMRI and MRI AutoDetect technology to make them compatible with magnetic resonance imaging systems.

Biotronik’s MRI AutoDetect feature allows the device to be set to automatically recognize MRIs and switch into MRI mode without having to directly interact with the device before and after the scan, the company said. After the scan, the device is designed to send a report to monitoring physicians outlining the operational switch.

“It is only in the last few years that cardiac device patients could safely undergo MRI scans at all. However, even now, patients aren’t fully protected if they have an event while their devices are programmed in MRI mode—a period that currently can last a day or more depending on hospital workflows. Reducing the amount of time a device is in MRI mode is particularly crucial for ICD and CRT-D patients, and with MRI AutoDetect the only time these patients won’t be able to benefit from full device therapy is the short 30-minute window they spend in the MRI machine itself,” Dr. Richard Kobza of Lucerne, Switzerland’s Luzerner Kantonsspital said in prepared remarks.

The devices also feature MultiPole Pacing, Biotronik said, which is designed to “further improve therapy for CRT patients,” and the company’s Closed Loop Stimulation algorithm.

“MRI AutoDetect is the next step in ensuring that patients get the full benefit of both their implanted devices and diagnostic imaging. MRI AutoDetect will not only reduce the amount of time the patient’s device stays in MRI mode, but I expect it will also greatly improve the workflow between the cardiologist and radiologist, which will ultimately benefit our patients,” senior veep Manuel Ortega said in a press release.

Last month, Biotronik said  it won CE Mark approval in the European Union for smaller sizes of its Passeo-18 Lux drug-coated balloon designed for treating peripheral arterial disease, specifically de novo and restenotic lesions in the infrainguinal arteries.

The device is now cleared in 2 mm and 2.5 mm sizes to facilitate treatment of below-the-knee arteries. Approval for the device was based on the randomized, controlled Biolux P-I clinical trial, with results published in theJournal of Endovascular Therapy.

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