Nuvectra Receives Full-Body MR-Conditional CE Mark Approval for Algovita

Nuvectra Corporation, a neurostimulation medical device company, has received full-body MR-conditional approval for the company’s Algovita SCS system from its European Notified Body, TÜV SÜD. The approval closely follows the company’s announcement regarding its receipt of head-only MR-conditional approval for Algovita from the U.S. Food and Drug Administration (FDA).
 
CEO Scott Drees commented, “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. 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.”
 
Nuvectra is a neurostimulation company committed to helping physicians improve the lives of people with chronic conditions. The Algovita Spinal Cord Stimulation (SCS) System is our first commercial offering and is CE marked and FDA-approved for the treatment of chronic intractable pain of the trunk and/or limbs. The company’s technology platform also has capabilities under development to support other indications such as sacral neuromodulation (SNM) for the treatment of overactive bladder, and deep brain stimulation (DBS) for the treatment of Parkinson’s Disease. In addition, Nuvectra’s NeuroNexus subsidiary designs, manufactures and markets neural-interface technologies for the neuroscience clinical research market.