Greatbatch Wins PMA Approval for Spinal Cord Stimulation System

The FDA has awarded PMA approval to Greatbatch for its Algovita spinal cord stimulation system for the treatment of chronic intractable pain of the trunk and limbs.

The system will be commercialized by the company’s QiG Group subsidiary, which will be spun off and renamed Nuvectra. According to Greatbatch, the spinoff will conclude in the first quarter of 2016.

The system received the CE Mark last year and is currently in limited release in Europe. — Michael Cipriano