Saturday, July 22, 2017

CompuFlo precise computer-controlled Epidural anesthesia system won clearance from the FDA.


Milestone Scientific, Inc., a company based at Livingston, New Jersey, has designed CompuFlo® Epidural instrument that uses dynamic pressure sensing (DPS) to help anesthesiologists to quantitatively determine and document the pressure at the needle tip in real-time.

The computerized system provides visual and audible feedback of the pressure which enables the anesthetist to correctly identify the epidural space and significantly reduce complications in real-time, according to Milestone.

Leonard Osser, Chief Executive Officer of Milestone Scientific commented, "We are delighted to receive marketing clearance from the FDA, which is considered globally to be the regulatory gold standard in premarket review."




The clearance was based on results of 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 study enrolled 400 patients, of whom 240 required epidurals as a relief from chronic pain and 160 patients were women, requiring epidural for pain management in labor and delivery.

The technique also showed the same efficacy in 21 obese patients with BMI > 31.

The application benefits of Milestone's CompuFlo-based Epidural Injection System are numerous and well defined, and include:
  • materially reducing, and possibly eliminating, existing medical risks and complications associated with administering epidurals
  • improving patient safety and comfort
  • reducing liability to medical care providers/institutions
  • reducing malpractice clams and related insurance premiums for anesthesiologist

The CompuFlo Epidural with Dynamic Pressure Sensing Technology is contraindicated in patients with prior back surgery in lumbar area, skin condition in their lumbar region greater than 4 sq cm and to infuse medication.

Media Courtesy: Milestone Scientific, Inc.

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