Flowonix Medical and Alliance Spine and Pain Centers announce first Prometra II implant


Flowonix Medical and Alliance Spine and Pain Centers have announced the first implant of the Prometra II intrathecal infusion pump in Georgia, USA. The intrathecal infusion device was implanted in a 56-year-old female suffering from severe chronic pain due to multiple sclerosis. The patient has been unable to get pain relief from oral pain medications due to severe adverse effects. The procedure was performed by David Rosenfeld.

“The Prometra pump offers clinicians an important option for treating patients suffering from chronic pain. In addition to the economic and clinical advantages of implantable pump therapy, the Prometra pump contains innovative technology for very accurate drug delivery and increased device longevity,” stated Rosenfeld.

Prometra II builds on the technology of the Prometra family. The most significant advancement in the Prometra II device is its proprietary flow-activated safety valve (FAV) technology, which is designed to allow patients to safely undergo magnetic resonance imaging (MRI). MRIs can be contraindicated for patients with implanted devices because of the strong electromagnetic energy from these systems which can interfere with proper device function. The Prometra II system is labelled as MR-conditional and can safely undergo such scans providing specific conditions are followed. These specific steps are described in the instructions for use supplied with the product.

Over 100 million people suffer from some form of chronic pain caused by injury or disease in the USA alone, and in some cases the pain is severe enough that it interferes with the person’s ability to work or lead a normal life. For such individuals, conventional pharmacological therapy or other pain strategies are often insufficient to control their pain. Implantable intrathecal drug pumps can help alleviate pain by automatically delivering pain medicine directly to the intrathecal space around the spine. In many cases, pain relief can be obtained with much less pain medication than conventional drug therapy.

“We realise this is an important milestone in the therapy for this patient, but it is also an important milestone for us as this is the first implant of the Prometra II system in Georgia,” stated Steven Adler, president and chief executive officer of Flowonix.