B. Braun this week said it received FDA 510(k) clearance for its SpaceStation MRI to allow infusion pumps to continuously deliver medications to patients in an MRI.
SpaceStation MRI is designed to shield Space infusion pumps against 1.5-T and 3.0-T magnetic fields to protect MR scanners while providing interference-free images. Space infusion pumps are able to safely transition patients into the imaging suite with the SpaceStation MRI, eliminating the need for long infusion lines.
“This clearance allows us to expand our infusion therapy portfolio by providing seamless infusion management across multiple care settings,” B. Braun director of marketing for infusion systems Jonathan Stapley said in a news release. “Our Space Infusion System allows standardization of large volume and syringe pumps on the same workflow with one integration.”
Each SpaceStation MRI holds up to 4 Space pumps and the TeslaSpy continuously monitors magnetic field strength to provide proper placement and positioning of the SpaceStation MRI. The pump status window allows for visibility of all infusion pumps with a centralized alarm display to continuously monitor the status on all infusions during imaging.
Space infusion lines can be used with the company’s Infusomat Space Large Volume Infusion Pump.
“Clearance of the SpaceStation MRI represents a significant development for patients and healthcare providers,” corporate VP of medical affairs Angela Karpf said. “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.”