Nuvectra Corporation out of Plano, Texas, won European MR-conditional approval for its Algovita spinal cord stimulator to be safe while receiving full body MRI scans. The Algovita implant is used to control chronic intractable pain of the trunk and/or limbs. It has 24 independent current sources to stimulate the spinal cord in a variety of ways. It is rechargeable and
The device currently has approval from the FDA for MRI scans to be safely done on the head, but not other body parts.
“Full-body MR-conditional approval in Europe further validates the safety of our Algovita system and follows our recent announcement of FDA head-only MR-conditional approval in the U.S.,” said Scott Drees, CEO of Nuvectra. “These approvals broaden our global competitive advantage while growing the number of patients eligible for Algovita. We look forward to the continued advancement of the system with submission for full-body MR-conditional approval to the FDA in early 2019.”