The System’s PMA has been converted to a Device Master File (MAF) that will be made available to customers to support their development of new neuromodulation therapies.
Minneapolis, MN—February 1, 2021 — Cirtec Medical Corporation, a strategic outsourcing partner for complex medical devices including active implantables, minimally invasive devices and novel catheter-based delivery systems, today 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 aligns with Cirtec’s strategy to support Academic, Research and Commercial partners with design, development, and manufacturing of active implantable device.
Brian Highly, Cirtec CEO stated, “We are pleased to provide this technology to our neuromodulation development partners. It demonstrates our commitment to serve 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 Corporation 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 Device Master File (MAF) that can be referenced by Cirtec customers for a variety of therapeutic applications.
Prof. Greg Molnar, PhD, University of Minnesota Medical School & MnDRIVE, MDIC Fellow, AIMBE Fellow commented, “Translating neuromodulation research concepts in academia just became much easier. Having access to Cirtec’s ‘SIMPLIFI’ clinical neurostimulation system and Master File can be leveraged to support physician-sponsored IDE studies that would otherwise not be possible.”
“Leveraging Cirtec’s SIMPLIFI Neuromodulation Platform has enabled Comphya to significantly reduce our cost and time to market by leveraging the existing validation reports and other objective evidence rather than creating our own,” said Cirtec customer, Rodrigo Fraga, CEO of Comphya.
About Cirtec Medical
Cirtec Medical is a vertically integrated, full-service outsource partner providing end-to-end product design, development, and manufacturing of Class III and II medical devices and components. We specialize in today’s most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist, structural heart, and minimally invasive systems. Cirtec has a global footprint with facilities in Brooklyn Park, MN; Chandler, AZ; Enfield, CT; Los Gatos, CA; Lowell, MA; Alajuela, Costa Rica; and Birkenfeld, Germany.