FDA Gives Flowonix’s Programmable Pump the Go-Ahead

The FDA granted Flowonix marketing approval for its Prometra II 40 mL programmable pump, a device that delivers medication directly into a patient’s spinal cord fluid.

The approval, which extends to the device’s accompanying software, expands the device’s reservoir size options to include both 20 and 40 mL pumps, and a battery with a 10-year life expectancy at average flow rates.

The implantable device allows therapy to be managed with lower doses of medication compared to orally ingested drugs and helps patients avoid building a tolerance to certain medications.