Flowonix Medical has received PMA-Supplement approval from the US Food and Drug Administration (FDA) for its intrathecal infusion device, the Prometra II system.
The Prometra II drug infusion device is a small, self-contained and battery-powered device, which helps in automatic dosing of drugs directly into the intrathecal space around the spine.
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."
The Prometra II features flow-activated safety valve (FAV), which helps patients to have magnetic resonance imaging (MRI) without the necessity of drug removal prior to the procedure.
According to the company, MRI is an imaging procedure that may be contraindicated for patients with implanted devices, while Prometra II system is labeled as MR-conditional and can safely undergo such scans providing specific conditions are followed.
The company plans to introduce the drug infusion device in the coming months.
Image: The Prometra II allows in automatic dosing of drugs directly into the intrathecal space around the spine. Photo: courtesy of rajcreationzs/ FreeDigitalPhotos.net.