FDA Clears Programmable Pump System for Intrathecal Baclofen for Spasticity

The Food and Drug Administration (FDA) has cleared a programmable pump system (Flowonix Medical, Prometra, Bud Lake, NJ) for use with intrathecal baclofen. Flowonix introduced the pump system 40 mL 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 the market for the delivery device by enabling its use in the treatment of spasticity. 

"Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had 1 device option," said Charles Argoff, MD, a neurologist at Albany Medical Center in Albany, NY and member of the Practical Neuology . "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 delivery device 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 delivery device.  The delivery device also features a 10+ year battery life, which can significantly reduce the number of future surgical procedures individuals 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. Although intrathecal baclofen is reserved for the most severe cases of spasticity, the number of individuals who could benefit from the therapy is significant.  

"This is a major milestone for Flowonix," said Larry Heaton, president and CEO, 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."