This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | OrganOx metra® System |
| Generic Name | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation |
| Applicant | OrganOx Limitedoxford Science Park, Magdalen Centre, Robert Robinson Avenueoxford OX4 4 PMA NumberP200035 Supplement NumberS002 Date Received03/21/2022 Decision Date05/27/2022 Product Code QQK Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-03-21 |
| Decision Date | 2022-05-27 |
| PMA | P200035 |
| Supplement | S002 |
| Product Code | QQK |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OrganOx Limited oxford Science Park, Magdalen Centre, Robert Robinson Avenue oxford OX4 4 PMA NumberP200035 Supplement NumberS002 Date Received03/21/2022 Decision Date05/27/2022 Product Code QQK Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement OrganOx Metra® New Enrollment PAS (Protocol Version 1, Dated November 2021)The OrganOx Metra® New Enrollment PAS Is A Multi-center, Single-arm, Unblinded Post-approval Study Designed To Compare Recipients Of PAS NMP Livers Versus IDE SCS Livers With Respect To Adverse Biliary-related Events. Recruitment Will Take Place At A Minimum Of 10 Sites Which Are UNOS Member Liver Transplant Centers.The New Enrollment PAS Study Will Include 210 Transplanted Livers From Deceased DBD And DCD Donors With A Minimum Of 40 Transplanted Livers From DCD Donors. Enrolled Subjects Will Be Followed For 12 Months Post-transplant.The Primary Objective Is To Compare The Effect Of NMP To SCS In The Prevention Of Adverse Biliary-related Events As Measured By Biliary Complications At 3 Months, 6 Months, And 12 Months Post-transplant. There Are Two Secondary Objectives. The First Is To Assess Graft Survival Rates At 3 Months, 6 Months, And 12 Months Post-transplant. The Second Secondary Objective Is To Assess Subject Survival Rates At 3 Months, 6 Months, And 12 Months Post-transplant. In Addition To The Above Data, The Following Preservation Parameters Will Be Collected For All Study Livers: Degree Of Steatosis At Time Of Retrieval, Quality Of In-situ Perfusion, Perfusion Parameters For NMP Livers, Perfusate ALT And AST (for NMP Livers), Lactate Levels (for NMP Livers), Perfusion Solution Used For In-situ And Back-bench Perfusion, Perfusion Solution Used For Organ Transport (SCS Organs Only), And Glucose Levels. The Following Inpatient/discharge Assessment Data Will Be Evaluated: Length Of Stay In ICU, Total Length Of Hospital Stay, Primary-non Function Via Evaluation Of Irreversible Graft Dysfunction Requiring Emergency Liver Replacement During The First 10 Days After Liver Transplantation, Biliary Complications, Biliary Interventions, Graft And Subject Survival, And Device-related Adverse Events. A Modified Intent-to-treat (mITT) Analysis Will Be Performed For All Outcomes As The Primary Analysis. The New Enrollment NMP Cohort In The MITT Population Will Be Compared Against The As-treated IDE Control Population (SCS) For The Primary Outcome. The Primary Outcome—the Difference In Biliary Complication Rates—will Be Analyzed Using Propensity Score Stratification To Adjust For Potential Differences In Risk Factors. Propensity Modeling Will Be Performed Based On The Baseline Characteristics Of Sex, Donor Age, Recipient Age, Donor Type, And Recipient MELD Score.Subgroup Analyses Will Be Performed For Donor Type (DCD Versus DBD), By Donor Risk Index (DRI), And By Duration Of Machine Preservation In The NMP Arm Of The Study. In The Event Of Missing Data, The Extent And Types Of Missing Data For Key Study Variables Will Be Assessed As Part Of Sensitivity Analyses And Reported Upon. Withdrawals From The Study After Transplantation Will Be Documented And A Summary Of Withdrawals Will Be Performed. For All Study Endpoints, Data Will Be Summarized For Those Recipients With Available Data.From The Time Of Study Protocol Approval, You Must Meet The Following Timelines For The New Enrollment PAS:a. The First Subject Is Enrolled Within 6 Monthsb. 20% Of Subjects Are Enrolled Within 12 Months C. 50% Of Subjects Are Enrolled Within 18 Months D. 100% Of Subjects Are Enrolled Within 24 Months E. The Submission Of Final Study Report Is Due 3 Months From Study Completion (i.e., Last Subject, Last Follow-up Date) |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200035 | Original Filing | |
| S003 | 2022-06-07 | Normal 180 Day Track No User Fee |
| S002 | 2022-03-21 | Normal 180 Day Track No User Fee |
| S001 | 2022-03-15 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 05060462240043 | P200035 | 002 |
| 05060462240005 | P200035 | 002 |
| 05060462240029 | P200035 | 002 |