FDA OKs Flowonix’s Prometra II Pump with Intrathecal Baclofen

Flowonix Medical Inc. received United States Food and Drug Administration (FDA) approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen. Flowonix introduced the Prometra II 40mL pump to the US market in November 2019, providing patients and clinicians a choice between 20 mL and 40 mL capacities when choosing an intrathecal pump delivery device. The new indication expands significantly the market for the Prometra device by enabling its use in the treatment of spasticity. Flowonix will begin marketing the device with the new indication immediately.
 
“Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had one device option,” said Charles Argoff, M.D., a neurologist at Albany Medical Center in Albany, N.Y. “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.”
 
Unlike the existing motor-driven pump, the Prometra II Pump utilizes a pressure-driven, valve-gated delivery mechanism to deliver boluses of medication into the intrathecal space. This innovative delivery mechanism provides broad spinal cord coverage rapidly and enables novel programming modes of intermittent flow followed by periods of no flow, unique to the Prometra device. The Prometra device also features a 10+ year battery life, which can significantly reduce the number of future surgical procedures patients will need to replace expiring pumps.
 
The American Association of Neurological Surgeons estimates that spasticity affects more than 12 million people worldwide, with common conditions such as cerebral palsy (CP), multiple sclerosis (MS), traumatic brain injury (TBI), spinal cord injury (SCI) and stroke comprising the majority of that population.  While intrathecal baclofen is reserved for the most severe cases of spasticity, the number of patients who could benefit from the therapy is significant.
 
“This is a major milestone for Flowonix,” said Larry Heaton, president and CEO, Flowonix. “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.”
 
The Prometra Pump was approved for use in the United States in 2012 with an indication for use to deliver INFUMORPH. To date, the Prometra System has been implanted in more than 8,000 patients worldwide, including use of the device to treat patients with severe spasticity outside the United States since its approval in the United Kingdom and European Union in 2011.