Valorem Surgical received U.S. Food and Drug Administration clearance for the MaxiMIS Spinal Fixation System and announced the first case using the system has been performed.
Jae Lim, MD, who practices in Reston, Va., performed the first surgery using the system. The system is intended for posterior pedicle screw fixation of the non-cervical posterior spine in adult patients. It was engineered for a minimally invasive approach.
"My elective practice is predominantly minimally invasive spine surgery, and the MaxiMIS System provides me with a well-designed, percutaneous pedicle screw system that is reliable and practical for my MIS cases," said Dr. Lim. "I found the system's instrumentation to work universally well with robotic guidance systems for MIS, which has become the standard of care for my surgical practice and treatment philosophy. MaxiMIS' low-profile design, combined with intraoperative flexibility and range of options to meet surgeon preferences makes for an effective, simple and reproducible solution."
The MaxiMIS system will be in limited market release through the end of the first quarter 2015, and a full launch is planned for the second quarter of this year.
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