01.15.15
Valorem Surgical, an early-stage medical device company with a platform on surgically treating spinal pathologies through a minimally invasive (MIS) approach, reports receiving U.S. Food and Drug Administration (FDA) clearance and the first case using its minimally invasive MaxiMIS spinal fixation system.
The procedure was performed by board-certified, neurosurgeon, Jae Lim, M.D., in Reston, Va.
The design of the MaxMIS system provides for an easy-to-use, percutaneous pedicle screw system that addresses single, complex, and multi-level spinal pathologies, according to company officials. The system was engineered for a minimally invasive approach for less tissue disruption, blood loss, and trauma. The system will be in limited market release through the end of the first quarter this year, and is planned for full launch in Q2.
"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 Chicago, Ill.-based 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.”
The MaxiMIS 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 x 25 millimeters (mm) to 10 x 100 mm, in monoaxial, polyaxial and cannulated variations.
“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," Lim said. "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."
Valorem Surgical was founded in 2011.
The procedure was performed by board-certified, neurosurgeon, Jae Lim, M.D., in Reston, Va.
The design of the MaxMIS system provides for an easy-to-use, percutaneous pedicle screw system that addresses single, complex, and multi-level spinal pathologies, according to company officials. The system was engineered for a minimally invasive approach for less tissue disruption, blood loss, and trauma. The system will be in limited market release through the end of the first quarter this year, and is planned for full launch in Q2.
"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 Chicago, Ill.-based 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.”
The MaxiMIS 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 x 25 millimeters (mm) to 10 x 100 mm, in monoaxial, polyaxial and cannulated variations.
“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," Lim said. "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."
Valorem Surgical was founded in 2011.