||hemodialyzer, high cut-off|
||Removal of free light chains for the treatment of dialysis dependent acute renal failure secondary to cast nephropathy in patients with multiple myeloma.
||The high cut-off technology hemodialyzer is characterized by larger membrane pore sizes resulting in a nominal cut off-point of 100 kilo Daltons (kDa) allowing removal of circulating substances with molecular weights up to a value of approximately 45 kDa. The membrane material used in this device is polyarylethersulfone (PAES) with an effective membrane surface area of 2.1 m².
||The high cut-off technology hemodialyzer is used on a conventional hemodialysis system with controlled ultrafiltration for the removal of free light chains. During therapy, anticoagulated blood taken from the patient flows via a tubing system through the high cut-off technology hemodialyzer and back into the patient's vascular system. Conventional dialysate solution is circulated in a counter-current direction through the dialysate compartment of the high cut-off hemodialyzer. To compensate for the removed fluid volume, a physiologic and isotonic replacement fluid is infused into the patient at a flow rate equal to or less than the filtrate flow rate.
||External communicating device in contact with circulating blood.
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Renal Devices Branch (RNDB)
HDE - Humanitarian Device Exemption
|Total Product Life Cycle (TPLC)
TPLC Product Code Report
|Third Party Review
||Not Third Party Eligible