Nuvectra has received full-body MR-conditional CE Mark approval for its Algovita SCS system.
The approval comes after the company announced its MR-conditional approval from the FDA for the Algovita.
“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.,” Scott Drees, CEO of Nuvectra, said. “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.”
The Algovita SCS system is a spinal cord stimulation system that is designed to treat chronic intractable pain in the trunk or limbs. It is currently being tested to support other indications like sacral neuromodulation to treat overactive bladder and for deep brain stimulation to treat Parkinson’s disease.