Milestone Scientific announced that the CompuFlo Epidural Computer Controlled Anesthesia System has received 510(k) clearance from the FDA. The CompuFlo Epidural System provides anesthesiologists and other healthcare providers — for the first time — the ability to quantitatively determine and document the pressure at the needle tip in real-time. The CompuFlo Epidural’s proprietary DPS Dynamic Pressure Sensing Technology (DPS) allows the CompuFlo Epidural to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space.
“We are delighted to receive marketing clearance from the FDA, which is considered globally to be the regulatory gold standard in premarket review,” says Leonard Osser, chief executive officer of Milestone Scientific. “I would like to thank all the employees, advisors, key-opinion leaders, and other stakeholders that were instrumental in helping us to achieve this major milestone.”
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 percent 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.
Based on the nonclinical and clinical tests conducted, it was demonstrated the the CompuFlo Epidural device is as safe, as effective and performs as well as or better than the legally marketed predicate devices.
The overall results of the COMPASS study demonstrated that the CompuFlo Epidural can serve as an everyday epidural needle placement confirmation solution.