Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol
April 24, 2023
Fresenius Kabi announces the availability of a single-needle venous access option for the Amicus® Extracorporeal Photopheresis (ECP) System at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT).
Fresenius Kabi is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition.
The Amicus Blue System with online ECP was launched in Europe in 2019 with double-needle venous access only. The update announced today includes new software v6.1 for the Amicus Separator, new software v2.1 for the Phelix Photoactivation Device and a new single-use disposable kit that can be configured for single or double-needle venous access. The system also allows clinicians to switch between single and double-needle access at any time during the procedure.
“We are thrilled to enable the single-needle option for the Amicus Blue ECP system, which will allow physicians to treat patients with limited venous access. This builds on our Amicus Blue vision to provide a versatile, multi-procedural instrument to support patients’ individual needs,” said Christian Hauer, President Fresenius Kabi MedTech.
The Amicus ECP System has obtained CE mark for the indication of CTCL in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. The Amicus ECP System is CE marked in compliance with the applicable requirements of the Medical Device Regulation (EU) 2017/745 and includes:
- Amicus Separator
- Phelix Photoactivation Device
- Amicus ECP Apheresis Kits
Amicus Separator is also cleared in Europe and the United States for therapeutic plasma exchange (TPE), red blood cell exchange (RBCx), mononuclear cell (MNC) collection and platelet collection. The Amicus ECP System is not cleared for use in the U.S.
Not all products listed are available or approved for sale in all countries. Contact your local Fresenius Kabi representative for additional information and product availability. Refer to the Amicus Separator Operator’s Manual and Phelix Photoactivation Device Operator’s Manual for a complete list of warnings and precautions associated with the use of these products.
About Extracorporeal Photopheresis
Extracorporeal photopheresis or ECP is a leukapheresis-based therapeutic procedure. The technology is currently approved for the treatment of cutaneous T-cell lymphoma (CTCL). Literature shows that it has also been used for graft versus host disease (GvHD) following bone marrow or stem cell transplant, the rejection of solid organ transplants, and autoimmune diseases where cell-mediated mechanisms are dominant.
An online ECP procedure involves collection of mononuclear cells from the patient, treatment of collected cells with a light sensitive drug, 8-methoxypsoralen and exposure of cells to UV-A light, followed by the reinfusion of treated cells back to the patient. After reinfusion, the treated cells become apoptotic and are believed to be taken up by antigen presenting cells resulting in an immune response. The online ECP process combines cell separation and photoactivation into a single, sterile circuit reducing the risk of infection and cross-contamination.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphomas are a heterogenous group of T-cell lymphoproliferative disorders involving the skin, the most common variants classified as Mycosis Fungoides (MF) or Sézary Syndrome (SS). Patients may experience itchy, scaly patches or plaques of the skin. As the disease progresses, some patients may experience growth of nodular lesions and large tumors, and internal organ involvement. Treatment is palliative, with the aim to induce long-term remissions and improve patient quality of life.
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients.
Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more.
With its corporate mission of "caring for life", Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face.
Following its “Vision 2026”, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders.
For more information, please visit www.fresenius-kabi.com.