FDA clearance and first clinical use of Valorem Surgical’s MaxiMIS spinal fixation system

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Valorem Surgical has received FDA clearance and completed its first case utilising its minimally invasive MaxiMIS spinal fixation system, performed by Jae Lim in Reston.

The MaxiMIS system offers a percutaneous pedicle screw system that addresses single, complex, and multi-level spinal pathologies. The system was engineered for a minimally invasive approach for less tissue disruption, blood loss, and trauma. The MaxiMIS will be in limited market release through the end of Q1 2015 and is planned for full launch in Q2 2015.

“The FDA clearance and first clinical use of the MaxiMIS pedicle screw system represents a notch in the win column in a challenging regulatory climate,” said Joseph Jin, president and chief executive officer of Valorem Surgical. “We believe we have developed and commercialised a next generation, minimally invasive solution.” 

The MaxiMIS is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilisation and immobilisation of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities. It is available as a minimally invasive or open screw system in comprehensive sizes from 4x25mm to 10x100mm, in monoaxial, polyaxial and cannulated variations.

Jae Lim, who performed the first case utilising the MaxiMIS, stated: “the MaxiMIS system provides me with a well-designed, percutaneous pedicle screw system that is reliable and practical for my minimally invasive cases. I found the system’s instrumentation to work universally well with robotic guidance systems for minimally invasive surgery, which has become the standard of care for my surgical practice and treatment philosophy.”