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BIOTRONIK consigue el cabeceo del FDA para los marcapasos MRI-compatibles de ProMRI Eluna

por Lauren Dubinsky, Senior Reporter | March 20, 2015
Cardiology MRI Stroke
ProMRI Eluna pacemaker system
Courtesy of BIOTRONIK
BIOTRONIK announced today that its ProMRI Eluna pacemaker system received FDA approval. The ProMRI technology built into it enables patients to undergo full-body MRIs with single-chamber and dual-chamber Eluna pacemakers when implanted with Setrox leads.

To develop an MRI-compatible pacemaker, the device itself needs to be made without any ferromagnetic components and the software and firmware that drive the device need to be capable of undergoing an MRI without the magnet field disrupting the computer programs.

In addition, the leads need to be designed to dissipate the energy generated by the MRI. “The leads are really the most important part,” Rex Richmond, vice president of marketing and communication at BIOTRONIK, told DOTmed News.

The magnetic field generated by the MRI creates energy, which is picked up by the leads, and then leads can transmit the energy back to the can or the heart in the form of heat. “Either one of those things is bad so the most important thing in an MRI system is that the leads be able to dissipate that energy of the MRI effectively,” said Richmond.

According to studies, most pacemaker patients — 86 percent — are 65 years old or older, about two-thirds of them have two or more chronic health conditions that may require an MRI and three out of four patients with pacemakers will need an MRI during their lifetime.

Previously, single-chamber pacemakers were not allowed to enter MRIs because of safety concerns and X-ray and CT cannot effectively image chronic neck or lower back pain, soft tissue masses and stroke symptoms. But now, the ProMRI technology gives those patients access to much-needed MRI exams.

The BIOTRONIK Home Monitoring system is also available with the Eluna pacemakers. It’s an Internet-based, automatic remote monitoring system that leverages the cellular phone network so physicians can monitor their patients’ status and the device status.

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