Royal Oak’s Innovative Surgical Solutions receives FDA approval for new device

Royal Oak’s Innovative Surgical Solutions, LLC (ISS) have received FDA clearance to market a new device that assists surgeons in locating and mapping motor nerves.

The NeuralMAS™ device uses mechanomyographic (MMG) signals and electrical stimulus of nerves to locate and identify spinal nerve roots and peripheral motor nerves originating from spinal levels C3-T1 and L2-S2.

“Our MMG-based NeuralMAS™ System is configured to identify muscle contraction in response to nerve stimulus”, stated Christopher Wybo, COO and VP of R&D.  “By measuring this muscle response, surgeons are able to accurately identify, map and avoid injury to nerves.”

The NeuralMAS™ Nerve Mapping and Avoidance System will compete with other monitoring systems that rely on EMG, but ISS’s product, using MMG signals, does not require a neurophysiologist to interpret signals for the surgeon.

Stephen Bartol, President and CEO of ISS, stated, “This is a surgeon operated, surgeon driven nerve monitoring system which will reduce the risk of nerve injury in minimally invasive spine surgery. The immediate applications will include the direct lateral approach to the lumbar spine where identification and mapping of nerves is critical for patient safety.”

Source: Innovative Surgical Solutions