FDA clear Precision Spine's next-gen minimally invasive spinal surgery tools

December 21, 2012 by MassDevice staff

Precision Spine lands FDA clearance for its Mini-Max Minimally Invasive Access System for spinal surgery.

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The FDA cleared Precision Spine's Mini-Max system, a minimally invasive access device designed to help spine surgeons achieve the same or better results than so-called "gold standard" open surgical procedures.

The system features the existing minimally invasive surgery techniques, but aims to shorten physicians' learning curves and reduce operating time, according to the press release.

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"We believe that the 1st phase launch of the Mini-Max Minimally Invasive Access System represents a significant advancement in minimally invasive approaches to spine surgery," president Rich Dickerson said in prepared remarks. "The advanced interbody device and additional products with designs that are optimized for use with the new system are in development now, and will further enhance the potential benefits of this new approach to MIS spine surgery."

The Mini-Max System is used with the company's S-LOK Pedicle Screw System, which provides immobilization and stabilization of spinal segments in adult patients to treat acute and chronic instabilities or deformities, the company said.

Dickerson said the system will be available in 2 phases. The base system enables pedicle screw-based tissue retraction and distraction for maximal access to the disc space. The phase 2, currently in the development phase, will enable parallel, bilateral distraction of vertebral bodies to facilitate effective placement of an advanced interbody device, he added.