Milestone Scientific announces results of CompuFlo effectiveness trial
Milestone Scientific announced the results of a 400 patient clinical trial by researchers from the University of Miami, University of Texas and Northwestern University and two California-based pain clinics. Published-ahead-of-print in Anesthesia & Analgesia, the randomized, controlled study compared the effectiveness of the CompuFlo Epidural System in labor and delivery and chronic pain management, where loss of resistance and fluoroscopy are the current standards of care. CompuFlo was found to be 99% successful in objectively identifying the epidural space, even in challenging patients with a higher body mass index. Performance of epidural anesthesia depends on successful identification of the epidural space. While fluoroscopy is associated with high success, it exposes patients to radiation and requires appropriate radiological equipment. Loss of resistance is subjective and consequently associated with higher failure rates and accidental dural punctures that require further treatment and interventions such as epidural blood patches. CompuFlo features a dynamic pressure sensing technology that differentiates tissue types by pressure signatures at the tip of the needle that are imperceptible by touch. This allows the instrument to accurately identify location and discriminate between true and false loss of resistance objectively and in real-time. The data from this pivotal study confirms that CompuFlo is a safe and effective alternative to current standards of care. The instrument avoids patient radiation exposure when compared to fluoroscopy and demonstrated greater accuracy when compared to loss of resistance. The clinical trial also found CompuFlo's procedure time was the same as the current standard of care and epidurals performed with CompuFlo resulted in no accidental dural punctures, compared to four dural punctures with loss of resistance.