FDA grants PMA-Supplement approval for Flowonix Medical’s Prometra II system

20 January 2015 (Last Updated January 20th, 2015 18:30)

The US Food and Drug Administration (FDA) has granted PMA-Supplement approval for Flowonix Medical's intrathecal infusion device, the Prometra II system.

The US Food and Drug Administration (FDA) has granted PMA-Supplement approval for Flowonix Medical's intrathecal infusion device, the Prometra II system.

Flowonix Medical intends to introduce the drug infusion device in the next few months.

The Prometra II drug infusion device is small, self-contained and battery-powered, which helps to automatically dose drugs directly into the intrathecal space around the spine.

It features a flow-activated safety valve (FAV), which helps patients have magnetic resonance imaging (MRI) without the necessity of drug removal prior to the procedure.

West Virginia University School of Medicine clinical professor of Anesthesiology Timothy Deer said: "The proprietary flow-activated safety valve was designed to shut off drug flow to the patient in the event a high flow rate occurs during an MRI procedure.

"The Prometra II drug infusion device is small, self-contained and battery-powered, which helps to automatically dose drugs directly into the intrathecal space around the spine."

"While the Flowonix Prometra infusion technology is already the most accurate and longest-lasting option for our patients, Prometra II increases safety and clinical convenience, should the patient require an MRI.

"This is an important advancement for the Prometra family of products and one that will be welcomed by physicians who treat chronic pain and cancer pain patients."

MRI is an imaging procedure that may be contraindicated for patients with implanted devices, while Prometra II system is labelled as MR-conditional and can safely undergo such scans, providing specific conditions are followed.

Flowonix Medical president Steve Adler said: "The new Prometra II drug infusion device is a major breakthrough for Flowonix, physicians, and patients, since it will improve the MR compatibility of the already state-of-the-art Prometra drug infusion device.

"The development and approval of the flow-activated valve demonstrates Flowonix's commitment to innovation and safety."