The U.S. Food and Drug Administration (FDA) has given medical device company Flowonix approval to market the Prometra II Programmable Pump System for use with intrathecal baclofen to treat severe spasticity in diseases, including cerebral palsy (CP).
The device was introduced to the U.S. market in November. By extending its use to treat spasticity — the continuous contraction of certain muscles — the agency’s approval should markedly expand Prometra’s market. The muscle relaxant intrathecal baclofen — sold as Gablofen by Piramal, Lioresal by Saol Therapeutics, and also in generic formulations — is used for spasticity, a condition that affects most children with CP.
In the Flowonix Prometra system, medication is delivered directly into fluid surrounding the spinal canal (intrathecal space), rapidly reaching the brain and spinal cord. Because the pump is implanted under the skin, therapy dosing can be managed better than when using oral treatments.
“Over the last several years, physicians utilizing implantable pumps to deliver long-term baclofen infusions have only had one device option,” Charles Argoff, MD, an Albany Medical Center neurologist, 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.”
Approved for use in the U.S. in 2012 to deliver infumorph for pain management, the new-generation Prometra II pump uses an innovative pressure-driven, valve-gated system to deliver medication. The mechanism offers swift and broad-based spinal cord coverage, and enables a unique programming mode of intermittent flow followed by periods of no flow. In addition, a 10-year battery life will greatly reduce the number of surgical procedures patients will need for pump replacement.
“This is a major milestone for Flowonix,” said Larry Heaton, the company’s president and CEO. “We believe the community of clinicians treating severe spasticity with intrathecal baclofen will find the Prometra system to be a welcome addition to their [resources] 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,” he said.
According to the American Association of Neurological Surgeons, roughly 12 million individuals worldwide are affected by spasticity. In cerebral palsy, symptom management can be complex and multifaceted, and can include electrical stimulation, botulinum toxin (Botox) injections, and occupational therapy.
The Prometra II pump has been implanted in more than 8,000 patients globally. It was approved in 2011 to treat severe spasticity in the United Kingdom and the European Union.