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Medical Devices / Submissions and Approvals

FDA Approves Biotronik’s ProMRI Eluna Pacemaker System

March 24, 2015

Biotronik has launched its ProMRI Eluna pacemaker in the U.S. market, following the receipt of FDA approval. The first implants are already underway, a company spokesperson told Device Daily Bulletin Monday.

ProMRI Eluna is the first single-chamber pacemaker approved for use with cardiac and thoracic MRI scans. The device allows patients with both single-chamber and dual-chamber versions to undergo full-body MRI scans when implanted with Setrox pacing leads.

Roughly 6.5 million people worldwide have pacemakers, and another million receive new ones each year, according to the German devicemaker.

The MRI-compatible pacemaker is already available in CE-mark countries. — Jason Scott