FDA Clearance For Mini-Max; Next Evolutionary Step In Spinal MIS Says Precision Spine

In short

Precision Spine has received 510(k) clearance from the FDA on November 20, 2012 for its Mini-Max Minimally Invasive Access System. The company believes this new system represents the next evolutionary step in the ongoing advancement of MIS spine procedures.

Background

Precision Spine says the addition of the Mini-Max Minimally Invasive Access System to the company’s expanding array of minimally invasive spinal solutions will enable spine surgeons to perform minimally invasive procedures using a versatile “access/fixation” system. It’s clearly targeting the achievement of results from an MIS procedure that are the same as or better than those achieved using the “gold standard”, open procedures and in so doing has incorporated features in Mini-Max that focus on muscle sparing and reproducibility.

The Mini-Max System is intended for use with the company’s S-LOK™ Pedicle Screw System, which is intended to provide immobilisation and stabilisation of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The S-LOK System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra) in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis, and failed previous fusion.

Physician comment

Dr. Donald Kucharzyk, Director of the Minimally Invasive Spine Surgery Institute (Crown Point, Indiana) and lead development surgeon for the new system commented, “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. 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.”

Company comments

Rich Dickerson, President of Precision Spine, stated, “We believe that the first phase launch of the Mini-Max Minimally Invasive Access System represents a significant advancement in minimally invasive approaches to spine surgery. We are planning to make the system available 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. The company’s commitment to research and product development continues to bear fruit with products such as the Mini-Max Minimally Invasive Access System, that offer unique advantages to surgeons, patients, hospitals and payers, and that are helping to differentiate us from our competition. 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.”

Source:  Precision Spine, Inc., Business Wire