The US Food and Drug Administration (FDA) has granted clearance for medical device firm Valorem Surgical’s MaxiMIS Spinal Fixation System.
The company, which has a viable portfolio of minimally invasive (MIS) spine solutions pending FDA clearance, announced the first case using its MaxiMIS Spinal Fixation System was performed by neurosurgeon, Dr Jae Lim in Reston, US.
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The system was developed for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.
Valorem Surgical president Joseph Jin said: "The MaxiMIS launch, coupled with our commitment to cost containment directives, comes at an opportune time to meet demand in the healthcare and orthopaedic device industry.
"We have addressed and improved upon the clinical shortages of existing systems, and remain focused on our goal of developing advanced, minimally invasive technology that enables surgeons to improve patient outcomes and reduce the associated costs of care."
It is claimed the system will offer stabilisation and immobilisation of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities.
The company said the system was designed for a minimally invasive approach for less tissue disruption, blood loss and trauma.
It is currently available as a minimally invasive or open screw system in sizes from 4mmx25mm to 10mmx100mm, in monoaxial, polyaxial and cannulated variations.
The company plans a limited market release of the system at the end of the first quarter of 2015. A complete launch is scheduled for the second quarter of 2015.
