Lower adverse event with MB-treated plasma compared to Quarantine plasma: 11 years’ experience in Greece
Tourcoing — October 8, 2014 – Macopharma is pleased to inform you that a current article from the Coordinating Haemovigilance Centre, Athens, Greece, entitled “Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma: 11 years’ experience.” has been recently published in the journal “Transfusion Medicine”1.
The aim of this study was to analyse cumulative haemovigilance data in order to compare the two secured therapeutic plasmas that have been in use for more than 11 years in Greece – methylene blue-treated fresh frozen plasma (MB-FFP) and quarantine fresh frozen plasma (Q-FFP) – regarding safety and adverse events.
The incidence of adverse events was higher with Q-FFP (1:3 620) than MB-FFP (1: 24 593) by a factor of 6.79. Allergic adverse events were also commoner with Q-FFP (1: 7 489) than with MB-FFP (1:24 593), by a factor of 3.28. All adverse reactions experienced by the MB plasma recipients were considered to be mild.
The authors conclude that “haemovigilance over 11 years has demonstrated the long-term safety of MB-FFP in comparison to untreated quarantine FFP. In addition to lowering the adverse event rate, implementing the system on a national scale in at-risk countries would presumably reduce the transmission of severe viral infections including emerging infectious diseases by transfusion.”
Macopharma SA (“Macopharma”) is an innovator in global healthcare with expertise in the fields of transfusion and infusion. The company has become the largest supplier of in-line leucodepletion filtration sets in Europe, It is expanding its efforts in the fields of respiratory masks and cellular therapy by developing products for cell expansion, in addition to cell/organ processing and freezing. Headquartered in the Lille metropolitan area (France), Macopharma has four manufacturing facilities in Europe and their products are sold into more than 70 countries worldwide. One of Macopharma’s aims is to provide a comprehensive range for the pathogen reduction of infectious agents in plasma, platelets and red cells. This is aligned with Macopharma’s product development strategy of the continuous quest, through partnerships, for improved safety, efficacy, and quality of transfusion, infusion, masks and cellular therapy.
About THERAFLEX MB-Plasma
The THERAFLEX MB-Plasma System has a Class III CE Mark (available for sale in countries where the CE mark is accepted) and is not currently available for sale in the United States. It is a user-friendly in-house treatment for single units of plasma. The GMP-conforming procedure is adapted for the inactivation of FFP from aphaeresis or whole blood plasma. The MB plasma system uses a combination of a membrane filter Plasmaflex PLAS4, (which removes residual leucocytes, red cells, platelets and aggregates, intra-cellular viruses and minimises the amount of microvesicles and microparticles), a dry Methylene Blue pill, visible light and a Blueflex Methylene Blue removal filter.
|1. Politis C, Kavallierou L, Hantziara S, Parara M, Zervou E, Katsarou O, Hatzitaki M, Fountouli P, Gioka A, Tzioura K, Koumarianos S, Asariotou M, Richardson C. Haemovigilance data on the use of methylene blue virally inactivated fresh frozen plasma with the Theraflex MB-Plasma System in comparison to quarantine plasma: 11 years’ experience. Transfus Med 2014.|