FDA Grants Marketing Approval For Prometra II Pump

The Prometra II offers a pressure-driven, valve-gated delivery mechanism that allows for novel programming modes of intermittent flow followed by periods of no flow—a feature unique to this device.

This article "Prometra II Pump Approved for Use With Spasticity Treatment Baclofen," was originally published on NeurologyLive®.

Patients with severe spasticity of cerebral or spinal origin received good news on Wednesday morning as Flowonix Medical Inc. announced the US Food and Drug Administration (FDA) has granted market approval for their Prometra II Programmable Pump System for use with intrathecal baclofen.

While a previous market approval brought about the introduction of the Prometra II 40 mL pump in November 2019, the latest approval means clinicians and patients now have a choice between 20 mL and 40 mL capacities, according to a statement from Flowonix.

"Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had one device option," Charles Argoff, MD, neurologist at Albany Medical Center, said in the aforementioned statement. "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."

Estimates from the American Association of Neurological Surgeons suggest that upward of 10 million individuals experience spasticity worldwide. It often impacts patients with conditions such as cerebral palsy (CP), multiple sclerosis (MS), traumatic brain injury (TBI), spinal cord injury (SCI), and stroke.2

The Prometra II differs from the existing motor-driven pump with a pressure-driven, valve-gated delivery mechanism. This novel approach, according to Flowonix, offers rapid and broad spinal cord coverage and allows for novel programming modes of intermittent flow followed by periods of no flow—a feature unique to this device.

Additionally, the device features a batter life of 10 years or more, which the company noted can significantly reduce the number of future surgical procedures to replace expiring pumps. The company also announced that the device will be marketed with its new indication beginning immediately.

"This is a major milestone for Flowonix," said Larry Heaton, president and CEO of Flowonix Medical, in a statement. "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 originally approved by the FDA in 2012 with an indication for use to deliver Infumorph. Prior to that, it got approval in the United Kingdom and European Union in 2011. To date, the system has been implanted in more than 8000 patients globally.