MDR Certification Granted to KORU Medical for Freedom60 Infusion Pump

KORU Medical Systems Inc.’s Freedom60 Infusion Pump and its adapter for 50 mL prefilled syringe use has achieved European Union Medical Devices Regulation (EU MDR 2017/745) certification.

The Freedom60 Infusion Pump supports dosing with 50 ml prefilled syringes, while the FreedomEDGE Infusion System provides a compatible option for 20 mL prefilled syringe formats. Together, these systems offer clinicians and patients flexibility across dosing regimens while maintaining a consistent, intuitive user experience, company bigwigs said.

EU MDR certification of both the Freedom60 and FreedomEDGE Infusion Pumps expands access to a system that supports the growing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy and simplifies home infusion for patients.

The increasing availability of prefilled syringe formats represents an important step forward in the evolution of SCIg therapy. Published studies have shown that prefilled presentations can:

• Reduce preparation and administration step vs. vials¹
• Minimize medication handling¹
• Decrease overall treatment burden²
• Improve patient confidence and independence with home therapy³

“EU MDR certification for the Freedom60 Infusion Pump marks an important step in expanding access to simpler, more patient-focused SCIg delivery across Europe,” KORU Medical Systems President/CEO Linda said. “As prefilled syringes become more widely adopted, patients are looking for solutions that reduce complexity and fit more easily into their daily routines. Our Freedom60 and FreedomEDGE systems are designed to meet that need—helping streamline therapy while maintaining the reliability that clinicians and patients expect.”

KORU Medical Systems develops, manufactures, and commercializes patient-centric large-volume subcutaneous infusion solutions that improve the quality of life for patients worldwide. The Freedom Syringe Infusion System (the Freedom System) currently includes the Freedom60 and FreedomEDGE Syringe Infusion Drivers, Precision Flow Rate Tubing, and HigH-Flo Subcutaneous Safety Needle Sets. The Freedom System, which received its first U.S. Food and Drug Administration clearance in 1994, is used for home self-administration by a patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products used by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, can customize the Freedom System for clinical and commercial use across multiple drug categories.

References
¹ CSL Behring LLC. Hizentra® PI 10 g Prefilled Syringe Leave-Behind (Document No. USA-HPI-0042; USA-HPI-0042-DEC23). Approved Dec. 21, 2023.
² Mallick R, Solomon G, Bassett P, Zhang X, Patel P, Lepeshkina O. Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies – impact of drug packaging and administration method on patient-reported outcomes. BMC Immunology. 2024;25:18. doi:10.1186/s12865-024-00608-0
³ Pandya D, Tavanti M, Hubsch A, Panaite A, Murphy E, Ramakrishna B, Mielke O. Successful simulation of infusion pump use for IgPro20 prefilled syringes. Poster 116. Presented at the Immunoglobulin National Society (IgNS) 13th National Conference; Oct 17–20, 2024; Washington, D.C. CSL Behring Medical Affairs.