KORU Medical claims that its Freedom Edge is the only device specifically approved for the delivery of subcutaneous Ig prefilled syringes
Repro Med Systems, doing business as KORU Medical Systems, has secured the US Food and Drug Administration (FDA) 510k approval for the use of its FreedomEdge infusion pump.
The infusion pump was indicated for delivering Hizentra [immune globulin subcutaneous (human) 20% liquid] in 20 mL prefilled syringes.
According to speciality infusion pharmacy NuFactor, the device simplifies the infusions as it requires patients to simply place the syringes in the pump and infuse, eliminating the difficult drug transfer process.
Hizentra is a sterilised solution made from human plasma, containing antibodies that help the body to protect itself against infection from various diseases.
It is manufactured and distributed by CSL Behring, a biopharmaceutical company focused on plasma-derived and recombinant therapeutic products.
The prescription medicine is currently used for treating chronic inflammatory demyelinating polyneuropathy (CIDP), and primary immunodeficiency (PI) diseases.
CIDP is an autoimmune disorder where the immune system attacks the nervous system, which causes muscle weakness and numbness.
The PI diseases include a humoral immune defect in congenital agammaglobulinemia, X-linked agammaglobulinemia, and Wiskott-Aldrich syndrome.
According to the company, Hizentra is the most prescribed subcutaneous Ig product and is the first to be offered in a prefilled syringe format.
KORU Medical is engaged in developing, manufacturing, and marketing advanced speciality infusion solutions to improve the quality of life for patients.
Its FREEDOM Syringe Infusion System includes the FREEDOM60 and FreedomEdge Syringe Infusion Drivers, precision flow rate tubing and HIgH-Flo needle sets.
KORU Medical chief executive officer Linda Tharby said: “As the leader in home delivery of subcutaneous immunoglobulin therapy, we are thrilled to add Hizentra prefilled syringes to our label.
“KORU Medical is committed to improving the patient home infusion experience. The KORU Medical FreedomEdge is the only infusion pump specifically indicated for delivery of a subcutaneous immunoglobulin prefilled syringe product.
“We will continue to innovate to improve patient comfort and support the innovations developed by our biopharmaceutical relationships such as CSL Behring.”