Cirtec Medical Corp., Minneapolis, announced a sponsor-initiated withdrawal of the premarket approval (PMA) for the Nuvectra Algovita Spinal Cord Stimulation System. The System was an FDA and CE Mark approved neurostimulation system with no open field actions at the time of acquisition.
The withdrawal of the PMA and subsequent creation of the Device Master File (MAF) aligns with Cirtec’s strategy to support academic, research, and commercial partners with the design, development, and manufacturing of the active implantable devices.
Brian Highly, Cirtec CEO stated, “We are pleased to provide this technology to our neuromodulation development partners. It demonstrates our commitment to serving as the leading end-to-end outsource partner in the neuromodulation market and will help to accelerate our customers’ time to market and minimize development spend.”
The announcement comes nine months after Cirtec acquired intellectual property and certain assets from Nuvectra Corp. with the goal of enhancing their SIMPLIFI Neuromodulation Solutions Platform. Cirtec will not commercialize the platform, instead, they will leverage this technology to support customers’ development of neuromodulation systems, with a complete MAF that can be referenced by Cirtec customers for a variety of therapeutic applications.
