Milestone Scientific has received 510(k) clearance from the US Food and Drug Administration (FDA) for its CompuFlo Epidural System to be used in the thoracic region of the spine, including the cervical thoracic junction.
The CompuFlo Epidural System previously received regulatory approval for use within the lumbar region of the spine, focusing on labour and delivery.
The system will use the company’s patented DPS Dynamic Pressure Sensing Technology in the newly expanded indications.
This will help anaesthesiologists and pain management providers easily navigate the challenging anatomy of the thoracic region and cervical thoracic junction in real time.
It will also simplify the epidural procedure by confirming the needle placement both audibly and visually.
Based on published clinical data, the CompuFlo Epidural System offers clinical and safety benefits that include significantly reduced complication rates and dural puncture numbers.
Furthermore, in an independent study, the system was found to reduce costs related to morbidity, offering healthcare institutions a direct economic benefit.
Milestone Scientific CEO Arjan Haverhals said: “Given the extensive published clinical data supporting successful epidural placement, we are pleased to expand 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.
“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 US on an annual basis.”
The company intends to expand the use of its technology within the area of pain management.
