FDA Clears Device to Avoid Nerve Injury Caused By “Positioning Effect”

SafeOp Surgical, Inc. has received 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), the goal being to identify “positioning effect” issues in anesthetised patients.


SafeOp says its 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. The newly FDA-cleared EPAD™ utilizes proprietary algorithms, electrodes, and cables, along with Bluetooth technology to allow easy set-up and integration into current operating room practices.

SafeOp’s system records SSEPs, which are particularly 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 device has a feature that flags SSEP changes that are consistent with so-called “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.

The company is currently introducing its device to a select number of centers, and will expand its commercial efforts in the second half of 2014.


Company comments

“Positioning effect is likely under-diagnosed and, despite caregivers’ best efforts, can occur in a significant number of surgeries. Until now it has often been considered a cost of doing surgery. As surgeries become longer and more complex, and utilize sophisticated technologies such as robotic assistance, a greater potential for positioning effect exists. Our system will proactively 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 easy and accurate suite of protocols for one-touch assessment of the NMJ when using paralytic agents,” said Richard O’Brien, MD, FRCP(C), MBA, chief medical officer at SafeOp. “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.”

“We are excited to bring neurological monitoring to a greater population of surgical patients in the U.S. market,” said Curt LaBelle, MD, MBA, president of SafeOp. “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.”

Source: SafeOp Surgical, Inc., Business Wire

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