Nuvectra said yesterday that it filed for expanded FDA approval of its Algovita spinal cord stimulation device.
The Plano, Texas-based company asked the federal safety watchdog for full-body MR-conditional approval for the Algovita SCS. The device first received FDA premarket approval in 2015.
“We believe full-body MR conditional approval in the U.S., in addition to Algovita’s full-body MR-conditional CE Mark approval, will supplement our existing competitive advantages and expand the number of eligible patients. We look forward to continually providing physicians with an innovative SCS system focused on improving patient outcomes worldwide,” CEO Fred Parks said in a press release.
Nuvectra said it hopes to win the PMA at or around year’s end, given the FDA’s 180-day review process.
Algovita is designed to treat chronic intractable pain of the trunk and lower limbs. It allows patients to customize their pain therapy for individual needs. The system features a rechargeable battery and an implantable pulse generator to stimulate the spinal cord.
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