Valorem Surgical, an early stage medical device company with a platform on surgically treating spinal pathologies through a minimally invasive (MIS) approach, today announced that the Company has received FDA clearance and its first case utilizing its minimally invasive MaxiMIS™ Spinal Fixation System, performed by board-certified, neurosurgeon, Dr. Jae Lim in Reston, VA. Valorem has a viable portfolio of MIS spine solutions pending FDA clearance and a robust development pipeline.
The intuitive design of the MaxiMIS™ Spinal Fixation System provides for an easy-to-use, 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™ Spinal Fixation System 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™ minimally invasive, pedicle screw system represents a notch in the win column in a challenging regulatory climate," said Joseph Jin, president and CEO of Valorem Surgical. "We believe we have developed and commercialized a next generation, minimally invasive solution, and are proud to celebrate this regulatory clearance and first case within a day of each other." Mr. Jin added, "The MaxiMIS™ launch, coupled with our commitment to cost containment directives, comes at an opportune time to meet demand in the healthcare and orthopedic 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."
The MaxiMIS™ Pedicle Screw Fixation System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization 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 4.0 x 25mm to 10.0 x100mm, in monoaxial, polyaxial and cannulated variations.
Commenting on the MaxiMIS™ Spinal Fixation System, neurosurgeon Dr. Jae Lim stated, "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." Dr. Lim added, "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."