Biotronik’s tiny, MRI-safe CRT pacemaker earns FDA nod

Biotronik's Edora CRT pacemaker is the smallest MR-conditional pacemaker on the U.S. market.

The FDA approved Biotronik’s MR-conditional cardiac resynchronization therapy (CRT) pacemaker, making it the smallest such device available in the U.S.

Heart failure refers to a group of symptoms in which the heart does not pump enough blood to support the body. Heart failure patients with arrhythmias may be treated with a CRT device, which is usually implanted just below the collarbone, according to the American Heart Association. Through leads, it delivers small pulses of electricity to the heart, which improves heart rhythm.

The Edora HF-T QP CRT pacemaker lasts 10 years and is MRI-conditional, opening up more diagnostic imaging options for patients who have the implant. It features Biotronik’s MRI AutoDetect technology, which minimizes the amount of time the device spends in MRI mode. This improves patient safety and eases programming challenges for physicians, Biotronik said in a statement.

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"With the launch of Edora HF-T QP, Biotronik offers a full suite of ProMRI products ensuring physicians can always choose MRI conditional devices for their patients," said Biotronik President Marlou Janssen in the statement. "Our devices are the only FDA-approved CRM solutions that provide automatic detection of an MRI environment, physiologic rate adaptation and automatic daily remote monitoring. These are differentiators that contribute to personalized and preventive care that impacts long-term health outcomes."

Last fall, St. Jude Medical bagged a CE mark for its own MR-conditional CRT pacemaker, while Medtronic earned FDA approval for its line of MRI-compatible cardiac rhythm and heart failure devices, including pacemakers, CRT defibrillators and implantable cardioverter-defibrillators.