Fresenius Kabi Launches Single-Needle Option for the Amicus® Extracorporeal Photopheresis Protocol

2023-04-24

细胞疗法

PARIS--(BUSINESS WIRE)--Fresenius Kabi today announced 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).

'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\u2019 individual needs'

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.

About Fresenius Kabi

Fresenius Kabi (www.fresenius-kabi.com) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s global headquarters is in Bad Homburg, Germany.