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.
Charles Argoff, MD, neurologist, Albany Medical Center
Charles Argoff, MD
The FDA has given market approval to Flowonix Medical’s Prometra II Programmable Pump System for use with intrathecal baclofen, which is used by patients with severe spasticity of cerebral or spinal origin.1
Although intrathecal baclofen is reserved for severe cases of spasticity, the number of patients who could benefit from the therapy is significant. This indication expansion follows the company’s prior market entry in November 2019, when the Prometra II 40 mL pump was introduced. This offers the choice between 20 mL and 40 mL capacities, Flowonix noted in a statement. It announced that the device with the new indication will be immediately marketed.
"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, Albany Medical Center, said in a 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 ≥10-year battery life, which the company noted can significantly reduce the number of future surgical procedures to replace expiring pumps.
"This is a major milestone for Flowonix," said Larry Heaton, president and CEO, 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.
1. Flowonix Receives FDA Approval to Market Prometra® II Pump for use with Intrathecal Baclofen [press release]. Mount Olive, NJ: Flowonix Medical; Published February 19, 2020. prnewswire.com/news-releases/flowonix-receives-fda-approval-to-market-prometra-ii-pump-for-use-with-intrathecal-baclofen-301007586.html. Accessed February 19, 2020.
2. Spasticity. American Association of Neurological Surgeons website. Updated 2020. aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed February 18, 2020.