Germany-based medical and pharmaceutical device firm B. Braun Medical a has received the US Food and Drug Administration (FDA) 510(k) approval for the SpaceStation MRI, to facilitate continuous deliver of medications to patients under the MRI suite.
The company said that its SpaceStation MRI is designed to protect Space infusion pumps from 1.5-T and 3.0-T magnetic fields, safe-guarding the MR scanner and deliver interference-free images.
Also, the device eliminates long infusion lines and enables Space infusion pumps to safely move patients into the imaging suite.
B. Braun Medical medical affairs corporate vice president Angela Karpf said: “Clearance of the SpaceStation MRI represents a significant development for patients and healthcare providers.
“It will allow patients to be safely transitioned into the MRI suite without the interruption of infusion therapy since there is no need to switch to an alternative pump. The versatility of the SpaceStation MRI accommodates adult, pediatric, and neonatal patients.”
SpaceStation MRI is designed to hold up to 4 Space pumps
SpaceStation MRI is designed to hold up to 4 Space pumps, including the Infusomat Space Large Volume Pump, Perfusor Space Syringe Pump, and the Perfusor PCA Syringe Pump, and has an integrated TeslaSpy, which continuously monitors magnetic field strength to facilitate its positioning.
The device holds a pump status window that provides visibility of all infusion pumps with a centralised alarm display to continuously monitor the status on all infusions during imaging.
SpaceStation MRI facilitates use of Standard Space infusion lines with the Infusomat Space Large Volume Infusion Pump and non-dedicated disposables for the Perfusor Space Syringe Infusion Pump.
Also, it features drug library software with the company’s DoseGuard Drug Library Development Software, supported by FDB Infusion Knowledge, which allows access to FDB reference materials, and customisable hard and soft drug limits.
B. Braun Medical infusion systems marketing director Jonathan Stapley said: “This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings.
“Our Space Infusion System allows standardization of large volume and syringe pumps on the same workflow with one integration.”
