FDA approves 6 MRI-safe ICDs and CRTs from Biotronik

Biotronik has received FDA approvals for two families of high-voltage cardiac rhythm management devices. The company now has a total of six FDA-approved devices for treating and resynchronizing tachycardia and arrhythmias.

The company describes its new Acticor and Rivacor product lines as the smallest and slimmest devices, at 10 mm, that are compatible with full-body MRI machines with magnetic field strengths up to 3 Tesla.

They include the Rivacor VR-T, DR-T and HF-T QP, and the Acticor DX, CRT-DX and CRT-DX Bipolar. Both device families also feature MRI AutoDetect technology, which recognizes when a patient enters an MRI environment and adjusts its therapy during the scan.

The Acticor line also provides atrial diagnostics without requiring an atrial lead, lowering the complexity of a procedure, and can detect silent atrial fibrillation while identifying dual-chamber supraventricular tachycardia to prevent unnecessary shocks.

Meanwhile, the Rivacor HF-T QP includes flexible programming options, which include 20 LV pacing vectors and cardiac resynchronization therapy, and can automatically adjust to changes in patient conditions.

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In addition, the battery lives of the VR-T, DR-T and DX models approach 15 years, with cardiac resynchronization models lasting nine years. Biotronik plans to make the devices available in the U.S. by this April.

Both families are also equipped with Biotronik Home Monitoring, which aims to reduce hospitalizations and mortality due to heart failure by collecting cardiac data from the device every night, typically while the patient sleeps. The system can also alerting physicians to changes in the patient’s health and the status of the device.