FDA Clears SafeOP Surgical’s Neurological Monitoring Device for Surgery

SafeOp Surgical Inc., a Greenwich, Conn.-based medical device start-up, has received U.S. Food and Drug Administration (FDA) clearance to market its Evoked Potential Assessment Device (EPAD). The device is portable and intended for use in monitoring neurological status by recording somatosensory evoked potentials (SSEPs) or assessing the neuromuscular junction (NMJ).

SafeOp’s system records SSEPs, which research has shown can be effective in revealing “positioning effect,” which refers to damage to peripheral nerves during surgery that is caused by the way the patient is positioned on the surgical table. Certain positions compress or stretch peripheral nerves, or cause compromised blood supply to the nerves, all of which can lead to damage if the patient’s position is uncorrected.

An everyday example of positioning effect is when a person wakes from sleep with an arm that is “dead” or “asleep.” The sleeping brain notifies the person to wake up and move or roll over to adjust position, which avoids nerve damage and quickly restores function. When under anesthesia, however, the patient can’t wake up and roll over, and thus nerve impairment can continue and lead to permanent injury.

SafeOp’s goal is to enable basic neurological monitoring in a wide array of surgical procedures where full monitoring, which requires the continuous presence of a technologist and neurologist, may not be indicated, cost effective or feasible. EPAD uses proprietary algorithms, electrodes, and cables, along with Bluetooth technology to allow easy set-up and integration into current operating room practices.

“Just as cardiac function and respiratory function are monitored in surgical procedures, we believe that nerve function monitoring will become standard of care in the future, resulting in fewer adverse events for patients,” President Curt LaBelle, M.D., said.

SafeOp’s device has a feature that flags SSEP changes that are consistent with positioning effect. This allows caregivers to examine waveforms and decide if the early stages of positioning effect might be present and, if so, to adjust the patient’s position to avoid nerve injury.

“Positioning effect is likely under-diagnosed and can occur in a significant number of surgeries. Until now it has often been considered a cost of doing surgery,” said Richard O’Brien, M.D., chief medical officer at SafeOp. “As surgeries become longer and more complex, and use sophisticated technologies such as robotic assistance, a greater potential for positioning effect exists. Our system will assist caregivers in deciding when to intervene and seeing if their intervention has made a difference. We also expect anesthesiologists to appreciate the EPAD’s suite of protocols for one-touch assessment of the NMJ when using paralytic agents.
Where comprehensive neuro-monitoring with a technician and neurologist is not indicated, but positioning effect or paralytic effect remains an issue, our system adds vital information at minimal cost.”

SafeOp plans to introduce its EPAD device to a select number of centers, and will expand its commercial efforts in the second half of the year. The company, formed through the acquisition of Impulse Monitoring Inc., is privately held and has been funded by Tullis Health Investors.