KORU Medical Earns MDR Certification for the Freedom60 Infusion Pump With Prefilled Syringe Compatibility

KORU Medical Systems Inc.’s Freedom60 Infusion Pump, including an adapter for use with 50 mL prefilled syringes, has achieved MDR certification.

The Freedom60 Infusion Pump is designed to support 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, according to the company.

EU MDR certification of both the Freedom60 and FreedomEDGE Infusion Pumps expands access to a system designed to support the growing use of prefilled syringes in subcutaneous immunoglobulin (SCIg) therapy and simplify the home infusion experience 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 CEO Linda Tharby 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. The Freedom Syringe Infusion 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 the 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 for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing 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, DC, USA. CSL Behring Medical Affairs.