Milestone Scientific, Inc., a company out of Livingston, New Jersey, achieved FDA clearance for its CompuFlo Epidural Computer Controlled Anesthesia System. Milestone’s DPS Dynamic Pressure Sensing Technology is able to provide precise and continuous measurement of the pressure at the tip of the syringe, both helping to guide anesthesiologists when accessing the epidural space and recording the procedure for any post-op review.
As the needle is advanced, the device provides both visual and audio feedback regarding the pressure levels being detected.
Here’s a bit of detail about the study that has helped to result in the FDA clearance, according to Milestone Scientific:
This clearance was supported by the COMPASS Study (CompuFlo® Assessment Study), which was a prospective, randomized, controlled, parallel group, multicenter, pivotal study to assess the safety and effectiveness of epidural space verification with the CompuFlo® Epidural Instrument. The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. The clinical study enrolled 400 patients, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundred-sixty (160) required epidural procedure for acute pain management during labor and delivery. The CompuFlo® Epidural with Dynamic Pressure Sensing Technology resulted in the anesthesiologists objectively identifying the epidural space with 99% success on the first attempt. The COMPASS study involved use of the CompuFlo Epidural in 21 obese subjects (BMI > 31), with performance in this group found to be comparable to the performance seen in patients with lower BMIs. However due to the relatively small sample size of obese patients studied, the safety and effectiveness profile in this subgroup of patients is not fully known.
Link: CompuFlo info page…