Prometra II 40 ml intrathecal pump receives FDA approvalDecember 6, 2019
Prometra II 40 mL programmable pump has received USFDA approval for intrathecal pain management in patients suffering from chronic non-malignant or cancer-related pain, Flowonix Medicals said.
The implantable drug delivery system is approved for intrathecal administration of preservative-free morphine sulfate sterile solution or preservative-free sterile 0.9% saline solution.
The intrathecal route of administration of drugs is carried out via injecting into the spinal canal, or into the subarachnoid space so as to reach the cerebrospinal fluid. It is useful in spinal anaesthesia, chemotherapy, or pain management applications. The pump delivers small quantities of pain medication such as morphine or baclofen, directly to the spinal fluid.
Prometra pump expands the reservoir size options to include both 20 ml and 40 ml pumps. The product also claims a 10-year battery life at average flow rates, potentially reducing the number of replacement surgeries in patients.
It is designed to operate similar to the previously approved 20 ml pump.
Intrathecal therapy is intended for patients who have not achieved adequate pain relief from therapies such as physical therapy, systemic opioids, non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, and anticonvulsants.