Royal Oak Firm Gets FDA Clearance For Surgical Product
Royal Oak-based Innovative Surgical Solutions LLC has received clearance from the United States Food and Drug Administration to market its NeuralMAS nerve mapping and avoidance system.
The NeuralMAS device is intended for use in surgical procedures to assist in locating and mapping motor nerves through the use of mechanomyographic signals and electrical stimulus of nerves.
“This is a surgeon operated, surgeon driven nerve monitoring system which will reduce the risk of nerve injury in minimally invasive spine surgery,” ISS president and CEO Stephen Bartol said. “The immediate applications will include the direct lateral approach to the lumbar spine where identification and mapping of nerves is critical for patient safety.”
Added Christopher Wybo, COO and vice president of research and development at ISS: “Our MMG-based NeuralMAS System is configured to identify muscle contraction in response to nerve stimulus. By measuring this muscle response, surgeons are able to accurately identify, map and avoid injury to nerves.”
NeuralMAS is indicated for locating and identifying spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.
“We expect to see early adoption among surgeons looking for a monitoring system that provides a safe way to perform lateral, trans-psoas fusions in the lumbar spine,” Bartol said. “We also expect early adoption for pedicle screw placement, particularly during minimally invasive approaches where risk of nerve injury appears to be higher.”
NeuralMAS will compete with other monitoring systems that rely on EMG. The FDA approval notice finds substantial equivalence between the NeuralMAS MMG System and the predicate EMG device.
“The advantage of MMG over EMG lies in the interpretation of signals,” Wybo said. “MMG does not require a neurophysiologist to interpret signals for the surgeon. Surgeons are able to drive the system and interpret the results themselves.”
More at http://innovativesurgery.com.
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