Precision Spine Gets FDA Clearance for MIS Spine Device
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Precision Spine’s Mini-Max minimally invasive access system.
The Mini-Max fits into the firm’s growing range of minimally invasive spinal products. According to the company, the new system will enable spine surgeons to perform minimally invasive procedures using an “access/fixation” system that has been designed to achieve results that are the same as or better than those achieved using the current gold standard open-surgery procedures.
Mini-Max also has been designed to offer several distinguishing features and benefits as compared with currently available minimally invasive surgery (MIS) systems. It reportedly uses techniques that are familiar to surgeons, potentially shortening any learning curve and reducing operative time. Its hardware and corresponding procedural steps are configured to facilitate greater direct visualization of the spine and easier access to the contralateral side and levels above and below the target level.
In eliminating the need to remove the screw tulip head during assembly, the design team sought to reduce “fiddle factor” (time wasted with uncertainty on how to proceed) as well as the overall number of procedural steps. The system’s muscle-sparing technique, contrasted with percutaneous approaches that puncture muscle, is anticipated to speed recovery time and improve patient outcomes. Precision’s design team focused on enabling more easily achieved procedure-to-procedure reproducibility, with the goal of enhancing cost-effectiveness for hospitals and payers.
“The development of the Mini-Max minimally invasive access system represents what we believe to be the next evolutionary step in the ongoing advancement of MIS spine procedures,” said Donald Kucharzyk, M.D., director of the Minimally Invasive Spine Surgery Institute in Crown Point, Ind., and lead development surgeon for the new system. “I believe that the incorporation of ‘minimally disruptive techniques’ familiar to spine surgeons, along with the ability to facilitate ‘maximum access’ through very small incision sites gives the new system significant advantages over the currently existing MIS spine systems now on the market. The development of this system was driven by our desire to make available to spine surgeons an MIS system that results in less surgical trauma to the patient, utilizing known muscle sparing techniques with resultant better patient recovery and outcomes. The system is expected to allow the achievement of those desired benefits, and to enable surgeons to perform everything that is possible through a classic open approach, but less invasively and with less disruption.”
Rich Dickerson, president of Precision Spine, said the device would be rolled out in two phases: “Phase 1, the base system, will enable pedicle screw-based tissue retraction and distraction for maximal access to the disc space. Phase 2, the additional system components, will enable parallel, bilateral distraction of vertebral bodies to facilitate even more effective placement of an advanced interbody device, which is now in the development phase.”
Precision Spine Inc., headquartered in Parsippany, N.J., with manufacturing facilities in Mississippi, makes spine technology.