Prometra II Pump Approved for Intrathecal Baclofen

FDA has approved a Flowonix Medical PMA for the Prometra II Programmable Pump System for an expanded use with intrathecal baclofen. Flowonix began marketing the 40mL pump 11/2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an intrathecal pump delivery device. The new indication enables the device’s use in treating spasticity, the company says.

Unlike its existing motor-driven pump, the Prometra II Pump uses a pressure-driven, valve-gated delivery mechanism to deliver boluses of medication into the intrathecal space, Flowonix says. The device also features a 10-year battery life, it says.

The Prometra pump is indicated for intrathecal infusion of drug therapy, including: Infumorph  (preservative free morphine sulfate sterile solution), preservative-free sterile 0.9% saline solution (sodium chloride injection, USP), and baclofen (baclofen injection, intrathecal, 500-2,000 mcg/mL).