Flowonix’s Prometra II Pump System Receives FDA Approval for Use with Intrathecal Baclofen
The U.S. Food and Drug Administration (FDA) has granted approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen for the treatment of spasticity across numerous conditions, including multiple sclerosis.
Intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by Saol Therapeutics, and also in generic formulations – is administered via an injection into the spinal canal. It is a skeletal muscle relaxant used to treat spasms, pain, and stiffness. It was designed for individuals who cannot tolerate oral baclofen, or who do not experience relief from tablets.
Unlike the currently available motor-driven pump, the Prometra II Pump uses a pressure-driven, valve-gated delivery system that transports the medication (in this case, baclofen) into the intrathecal (spinal) space. This innovative delivery system allows the medication to be infused quickly, with a broad dispersion, into the spinal cord.
The system can be programmed, using a hand-held remote device, to have periods of flow followed by periods of no flow, which is unique to the Prometra device.
The Prometra II Pump also has a battery life of more than 10 years, which substantially reduces the amount of future surgical procedures that patients have to go through to replace the pump.
To date, the Prometra System has been implanted in more than 8,000 patients worldwide, including patients with severe spasticity in the United Kingdom and European Union, where it was approved in 2011.
Aside from baclofen, the Prometra II Programmable Infusion Pump System is approved for the intrathecal infusion of two other therapies — Infumorph (preservative free morphine sulfate sterile solution), and preservative-free sterile 0.9% saline solution (Sodium Chloride Injection).