Milestone Scientific’s CompuFlo Epidural System OK’ed for Thoracic Indications

Milestone Scientific, a developer of computerized drug delivery instruments for painless and precise injections, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its CpompuFlo epidural system for use in the spine’s thoracic region, including the cervical thoracic junction.
 
The approval expands on CompuFlo’s prior approval for use in the lumbar spine, where the focus was on labor and delivery.
 
The newly expanded indications provides anesthesiologists and pain management providers the ability to navigate difficult anatomical regions in the thoracic and cervical thoracic junction in real-time, confirming needle placement audibly and visually to make the epidural injection easier and safer to administer.
 
According to the company, extensive published clinical data demonstrated “significant reductions” in dural punctures and complication rates, and also contributed time savings. An independent study showed the CompuFlo epidural system may reduce costs associated with morbidity.
 
Dr. Ronny Hertz, MD, an anesthesiologist and pain management physician, as well as an advisor to Milestone Scientific, stated to the press, “Each year spinal cord injury cases are reported as a result of epidural procedures, especially in the thoracic and cervical regions. We believe this approval will be of benefit to physicians who have been trained in the placement of epidurals in the thoracic and cervical regions of the spine, including anesthesiologists and pain management providers due to the difficulties accessing the epidural space, especially in the higher thoracic cervical regions of the spine. The use of the CompuFlo Epidural System in these regions will add another level of safety, efficiency and confidence as it audibly and visually measures tissue pressures in real time, allowing a provider to confirm the needle placement. I believe it will also be of tremendous assistance for spinal cord stimulator cases.”
 
Dr. Hertz added, “The CompuFlo device should also be beneficial in teaching residents and nurse anesthetists the proper placement of epidural needles since it provides the instructor and student audible and visual confirmation when the tip of the needle is in the correct location. Every medical technique has risks, but it is the job of the healthcare provider to try to reduce those risks, and I believe CompuFlo has the potential to become the new standard of care.”
 
Arjan Haverhals, CEO of Milestone Scientific, noted, “We are delighted to receive marketing clearance from the FDA for this new thoracic indication. Given the extensive published clinical data supporting successful epidural placement, we are pleased to expand the scope of indications beyond labor and delivery into challenging thoracic and cervical epidural procedures, where the incidence rates of morbidity are believed to be much higher, at 17% and 30%, respectively. The FDA clearance represents a major milestone as it broadens the market opportunity for CompuFlo Epidural System, with approximately 11 million epidural procedures performed in the U.S. on an annual basis. We look forward to expanding the use of our technology within the area of pain management and remain encouraged by the interest in our epidural instruments by anesthesiologists and pain management providers, especially for patients with complex anatomy and difficult cases that involve the thoracic and cervical thoracic junction.”