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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