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Il sistema Mirasol, l‘esperienza di un centro italiano

Il sistema Mirasol, l‘esperienza di un centro italiano. Dott.ssa Paola Isernia. The Mirasol PRT System – Overview. Reduction of viruses, bacteria, parasites Inactivation of residual leucocytes. +. +. Riboflavin (vitamin B2) solution. Blood product. UV Light.

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Il sistema Mirasol, l‘esperienza di un centro italiano

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  1. Il sistema Mirasol, l‘esperienza di un centro italiano Dott.ssa Paola Isernia

  2. The MirasolPRT System – Overview • Reduction of viruses, bacteria, parasites • Inactivation of residual leucocytes + + Riboflavin(vitamin B2) solution Blood product UV Light

  3. Mirasol System is Safe for Patients and Staff • Riboflavin and its photoproducts are naturally present in normalblood, no new compounds are formed • Riboflavin and its photoproducts arenon-toxic & non-mutagenic • Extensive toxicology testing has shown no safety concerns • Mirasol does not require removalof riboflavin or its photo-products • No contra-indications for patients • No special precautions for staff

  4. Riboflavin: the ideal sensitizer Riboflavin (vitamin B2) Essential nutrient, Recommended daily allowance 1.7 mg Toxicology, Mutagenicity (GRAS, USA FDA) GRAS= Genreally Regardes As Safe

  5. Transfuse or store for up to five days Transfer to storage bag Connect and transfer product toillumination bag Add riboflavin solution Illuminate 4 to10 minutes Add riboflavin solution Connect and transfer product to illumination bag Illuminate4 to10 minutes Mirasol System Process for Platelets and Plasma Platelets Same simple process for platelets and plasma Transfuse or store frozen for up totwo years Plasma

  6. Broadly Effective Against Pathogens Effectiveness Demonstrated Against Broad Range of Clinically Relevant Pathogens • Closing of window period for tested pathogens (known viruses) • Added protection against untested pathogens (parasites, emerging pathogens) • More effective than bacterial culture methods in use today (Goodrich et al. 2009)

  7. Effective Inactivation of White Blood Cells Reducing Immunological Complications of Transfusion • Mirasol system may be used as alternative to Gamma-irradiation for the prevention of transfusion-associated Graft-versus-Host Disease (approved claim) • Mirasol system may reduce other immunological complications caused by contaminating WBCs; additional studies are in progress to evaluate this

  8. Operational Flexibility and Efficiency Efficient process • <15 minutes total process time • <5 minutes hands-on time • Broad treatment ranges • Minimal product loss (1–2%) • No removal step required, immediate product release • Comprehensive data reportingand traceability Flexibility – A single system for all your platelet and plasma products • Platelets in PAS or in plasma, from apheresis or whole blood • Plasma (FFP),from apheresis or whole blood

  9. The Hemovigilance (HV) Program So far: • 16,213 transfusions of Mirasol-treated platelet concentrates (PC) have been reported to our HV-program • 32,165 transfusions of Mirasol-treated FFP have been reported • Fifty-nine adverse events were reported after transfusion of PC and 10 after transfusion of FFP. No adverse events related to the medical device. • Participation of centers is on voluntary basis. The current list of participants under routine use is: • One site each in Poland, Serbia, Greece, Lithuania , Luxemburg and 2 sites in Italy • The program includes transfusion data from MIRACLE, CAP and MEP studies • Currently, a bi-monthly questionnaire is sent to the sites • A databank is being developed to be located at our sharepoint address. • It will enable customers in the future to update their own data by themselves with permission by user ID and password

  10. IPTAS Study IPTAS = Italian Platelet Technology Assessment Study Platelets in PAS • Conducted by IPTAS Study Group in Italy • Primary endpoint: Patients with ≥ Grade 2 bleeding • A total of 828 subjects targeted at 6 sites, 3 Mirasol (Pavia, Roma and Genova) and 3 Intercept (Verona, Milan, TBD)

  11. The Pavia experience • Platelet product characteristics • Collection platform: Trima • Target dose: 3.6 x 1011; Average volume: 270mL • Percent Plasma: 33% • PAS: SSP+ (added manually after Trima collection) • Software integration

  12. Implementation in routine • Mirasol procedures : • Implementation: October 28, 2010 • Test/Validation phase : X procedures in (when?) • Routine implementation in November 2010 • Procedures to date : ? • Number of patients treated : 36

  13. Interim observation • Ease of use • Uncomplicated training of technicians • Rapid process • Easy integration to routine process • Safe for operators • Flexible: applicable to a broad range of products

  14. QUESTIONS? Thank you !

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