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.
“Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had one device option,” Charles Argoff, MD, a neurologist at Albany Medical Center, said in a press release.
“The availability of a totally new pump to assist in the management of severe spasticity allows for a meaningful new option for those patients who suffer from this condition,” Argoff said.
The American Association of Neurological Surgeons estimates that more than 12 million people in the world experience spasticity symptoms, including patients with multiple sclerosis, but also cerebral palsy, spinal cord injury, traumatic brain injury, and stroke.
According to Flowonix, although treatment with intrathecal baclofen is reserved for severe cases of spasticity, the number of patients who may benefit from this therapy is significant.
Flowonix originally introduced the 40 milliliter (mL) Prometra II pump in the U.S. market in late 2019, giving patients and physicians a choice between 20 mL and 40 mL capacities.
This new indication now expands the market for the Prometra device by allowing its use in the treatment of spasticity. Flowonix has plans to start marketing the device for the new indication immediately.
“This is a major milestone for Flowonix,” said Larry Heaton, president and CEO of Flowonix Medical. “We believe the community of clinicians treating severe spasticity with intrathecal baclofen will find the Prometra System to be a welcome addition to their armamentarium for treating their patients, and we will be working with leading physicians in the field to establish Prometra as the standard of care in intrathecal baclofen therapy.”
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).
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