US-based biomedical technology company Milestone Scientific has received an expanded US Food and Drug Administration (FDA) 510(k) approval for its CompuFlo Epidural System.
The CompuFlo Epidural System was previously approved in the US for use within the lumbar region of the spine, focusing on labour and delivery.
With the expanded FDA approval, the system can now be used in the thoracic region of the spine, including the cervical thoracic junction.
According to the company, the approval expands the scope of indications beyond labour 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.
Milestone Scientific chief executive officer Arjan Haverhals said: “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 anaesthesiologists and pain management providers, especially for patients with complex anatomy and difficult cases that involve the thoracic and cervical thoracic junction.”
The expanded approval for CompuFlo Epidural System is said to help anaesthesiologists and pain management providers easily navigate challenging anatomical regions in the thoracic region and cervical thoracic junction in real-time.
Also, the system uses the company’s patented DPS Dynamic Pressure Sensing Technology to confirm the needle placement both audibly and visually, simplifying the epidural procedure.
Based on published clinical data, the CompuFlo Epidural System offers clinical and safety benefits, including a reduction in dural punctures and complication rates.
According to an independent study, the system has been shown to reduce costs related to morbidity and offered a direct economic benefit to healthcare institutions.
Milestone Scientific advisor and anaesthesiologist and pain management physician Ronny Hertz said: “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.
“The CompuFlo device should also be beneficial in teaching residents and nurse anaesthetists 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.”
