Dialysis Accessories – Pipeline Products by Stage of Development 12
Dialysis Accessories – Pipeline Products by Segment 13
Dialysis Accessories – Pipeline Products by Territory 14
Dialysis Accessories – Pipeline Products by Regulatory Path 15
Dialysis Accessories – Pipeline Products by Estimated Approval Date 16
Dialysis Accessories – Ongoing Clinical Trials 17
Dialysis Accessories Companies – Pipeline Products by Stage of Development 18
Dialysis Accessories – Pipeline Products by Stage of Development 20
Access Vascular Inc Pipeline Products & Ongoing Clinical Trials Overview 22
Dialysis Port – Product Status 22
Dialysis Port – Product Description 22
Ash Access Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 23
MaxFlow – Product Status 23
MaxFlow – Product Description 23
Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 24
oXiris – Product Status 24
oXiris – Product Description 25
Point of Care Generation 1 System – Product Status 25
Point of Care Generation 1 System – Product Description 25
Point of Care Generation 2 System – Product Status 26
Point of Care Generation 2 System – Product Description 26
Baxter International Inc – Ongoing Clinical Trials Overview 27
oXiris – A Pilot Multicentre Open-Label Randomized Controlled Trial During Treatment for Acute Kidney Injury in Critically Ill Patients with Septic Shock Comparing Two Haemofilter Membrane Devices, The An69st and the Newly Available Oxiris Haemofiltration Membrane for Early Resolution of Shock As Well As Other Clinical and Technical Performance Outcomes 28
oXiris – A Randomized, Controlled Trial to Evaluate Efficacy and Safety of a Highly Selective Semipermeable Membrane (AN-69 Oxiris) in Comparison with a Semi Selective Semipermeable Membrane (Standard AN-69) in COVID-19 Associated Acute Kidney Injury: oXAKI-COV Study 28
oXiris – Antibiotic Plasma Concentrations During Continuous Renal Replacement Therapy with a High Adsorption Membrane (oXiris) 29
oXiris – Clinical Study of Microcirculatory Parameters in Septic/Septic Shock Patients Treated with Oxiris Filter 30
oXiris – Effect of Oxiris Membrane on Microcirculation Following Cardiac Surgery Under Cardiopulmonary Bypass: A Pilot Prospective Monocentric Study (Oxicard Study) 30
oXiris – Effects of Removal of Endotoxin, Cytokines, and Uremic Toxins Using Blood Purification on Patients with Severe Septic Shock 30
oXiris – Endotoxins and Cytokines Removal During Continuous Hemofiltration with oXiris 31
oXiris – Evaluation of Oxiris Membrane as a Treatment for Ischemia-reperfusion Syndrome in Cardiogenic Shock Treated with Extracorporeal Life Support (ECMO/ECLS): A Randomized Pilot Study ECMORIX 31
oXiris – Renal Replacement Therapy with a Cytokine Absorption Filter (oXiris) in Patients with Septic Shock: a Case-control Study Nested in a Cohort 31
oXiris – The Effect of a Hemoperfusion with Polyethyleneimine-coated Membrane Filter (Oxiris) in Patients with Septic Shock: A Multicenter Randomized Controlled Trial 32
oXiris – The Effects of oXiris on Systemic Inflammation, Endothelial Dysfunction and Volume Control in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass 32
Brookhaven Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 33
Hemoaccess Valve System – Product Status 33
Hemoaccess Valve System – Product Description 33
CatheNect Medical Pipeline Products & Ongoing Clinical Trials Overview 34
Peritoneal Dialysis Catheter – Product Status 34
Peritoneal Dialysis Catheter – Product Description 34
Cerovations LLC Pipeline Products & Ongoing Clinical Trials Overview 35
Contamination Resistant Interconnection Device – Product Status 35
Contamination Resistant Interconnection Device – Product Description 35
Diavantis Pipeline Products & Ongoing Clinical Trials Overview 36
Vivaxs Liva – Product Status 36
Vivaxs Liva – Product Description 36
Diavantis – Ongoing Clinical Trials Overview 37
Vivaxs Liva – Bone Anchored Port – A Novel Vascular Access for Hemodialysis Treatment 38
Eqalix, Inc. Pipeline Products & Ongoing Clinical Trials Overview 39
RenalEase – Product Status 39
RenalEase – Product Description 39
ExThera Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 40
Seraph 200 – Product Status 40
Seraph 200 – Product Description 40
Fistulink Ltd. Pipeline Products & Ongoing Clinical Trials Overview 41
Fistulink Device – Product Status 41
Fistulink Device – Product Description 41
Fresenius Medical Care AG & Co KGaA Pipeline Products & Ongoing Clinical Trials Overview 42
FX CorAL 600 – Product Status 42
FX CorAL 600 – Product Description 42
Fresenius Medical Care AG & Co KGaA – Ongoing Clinical Trials Overview 43
FX CorAL 600 – Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration – eMPORA III Study (Modified Polysulfone membrane) 44
Gambro Dialysatoren GmbH Pipeline Products & Ongoing Clinical Trials Overview 45
Theranova 400 Dialyzer – Product Status 45
Theranova 400 Dialyzer – Product Description 45
Theranova 500 Dialyzer – Product Status 46
Theranova 500 Dialyzer – Product Description 46
Gambro Dialysatoren GmbH – Ongoing Clinical Trials Overview 47
Theranova 400 Dialyzer – A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed with the Theranova HDx in Comparison to On-Line – Hemodiafiltration (Study MoTHER HDx) 48
Theranova 400 Dialyzer – A Randomized, Controlled, Open-label, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration 48
Theranova 400 Dialyzer – A Randomized, Open-label, Cross Over Group, Single-centre Controlled Study To Evaluate The Clinical Performance Of Medium Cut-off Membrane Dialyzer Compared with High Flux Dialyzer in Removing Beta-2- Microglobulin Among Patients with End-stage Kidney Disease On Chronic Haemodialysis 48
Theranova 400 Dialyzer – Effect of Hemodiafiltration Plus MCOs on Uremic Toxins Removal 49
Theranova 400 Dialyzer – Long-term Effects of Expanded Hemodialysis in Reduction of Large Middle Molecules in Chronic Hemodialysis Patients: Potential Benefits to the Prevention of Sarcopenia 49
Theranova 400 Dialyzer – Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function in Incident Hemodialysis Patients 49
Theranova 500 Dialyzer – A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed with the Theranova HDx in Comparison to On-Line – Hemodiafiltration (Study MoTHER HDx) 50
Georgia Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 51
Disposable Cassette Device – Dialysis – Product Status 51
Disposable Cassette Device – Dialysis – Product Description 51
Glomeria Therapeutics srl Pipeline Products & Ongoing Clinical Trials Overview 52
DesmoHD – Product Status 52
DesmoHD – Product Description 52
Healionics Corporation Pipeline Products & Ongoing Clinical Trials Overview 53
STARcuff – Product Status 53
STARcuff – Product Description 53
Indian Institute of Technology Bombay Pipeline Products & Ongoing Clinical Trials Overview 54
Dialysis Cuff – Product Status 54
Dialysis Cuff – Product Description 54
Innovative BioTherapies Inc Pipeline Products & Ongoing Clinical Trials Overview 55
Selective Cytopheretic Device Gen 2 – Pediatrics – Product Status 55
Selective Cytopheretic Device Gen 2 – Pediatrics – Product Description 55
Innovative BioTherapies Inc – Ongoing Clinical Trials Overview 56
Selective Cytopheretic Device Gen 2 – Pediatrics – A Multi-center, Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) for the Treatment of Immunomodulatory Dysregulation Due to Pediatric Acute Kidney Injury (AKI) 57
Katharos, Inc. Pipeline Products & Ongoing Clinical Trials Overview 58
Phosphates Removing Device – Hemodialysis – Product Status 58
Phosphates Removing Device – Hemodialysis – Product Description 58
Laminate Medical Technologies Ltd Pipeline Products & Ongoing Clinical Trials Overview 59
VasQ – Product Status 59
VasQ – Product Description 59
Laminate Medical Technologies Ltd – Ongoing Clinical Trials Overview 60
VasQ – A Multi-center Prospective Study to Evaluate the Safety and Effectiveness of the VasQ External Support for Arteriovenous Fistula 61
Nikkiso Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 62
Blood Volume Monitor For DCG-03 / DBG-03 – Product Status 62
Blood Volume Monitor For DCG-03 / DBG-03 – Product Description 62
Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 63
SafeTouch Dialysis CATH Plus P – Product Status 63
SafeTouch Dialysis CATH Plus P – Product Description 63
Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 64
Adjustable Banding Device – Product Status 64
Adjustable Banding Device – Product Description 64
Novaflux Technologies Pipeline Products & Ongoing Clinical Trials Overview 65
Outside-In (OI) Dialysis Filter – Product Status 65
Outside-In (OI) Dialysis Filter – Product Description 65
NuVascular Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 66
NuSpun Central Venous Catheter Cuff – Product Status 66
NuSpun Central Venous Catheter Cuff – Product Description 66
NuSpun Hemodialysis Access Graft – Product Status 67
NuSpun Hemodialysis Access Graft – Product Description 67
Pursuit Vascular, Inc Pipeline Products & Ongoing Clinical Trials Overview 68
ClearGuard HD End Cap – Product Status 68
ClearGuard HD End Cap – Product Description 68
Rajamadhangi Medical Technologies Pvt Ltd Pipeline Products & Ongoing Clinical Trials Overview 69
Dialysis Cartridge – Product Status 69
Dialysis Cartridge – Product Description 69
Redsense Medical AB Pipeline Products & Ongoing Clinical Trials Overview 70
Redsense Clamp – Product Status 70
Redsense Clamp – Product Description 70
Renal Solutions Inc Pipeline Products & Ongoing Clinical Trials Overview 71
Dialysate Regeneration System – Peritoneal Dialysis – Product Status 71
Dialysate Regeneration System – Peritoneal Dialysis – Product Description 71
SeaStar Medical Pipeline Products & Ongoing Clinical Trials Overview 72
Selective Cytopheretic Device – Adult Use – Product Status 72
Selective Cytopheretic Device – Adult Use – Product Description 72
Selective Cytopheretic Device – Pediatric Use – Product Status 73
Selective Cytopheretic Device – Pediatric Use – Product Description 73
SeaStar Medical – Ongoing Clinical Trials Overview 74
Selective Cytopheretic Device – Adult Use – Immunomodulatory Biomimetic Device to Treat Myocardial Stunning in End-stage Renal Disease Patients (ERSD) 75
Selective Cytopheretic Device – Adult Use – Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat Patients with NYHA Stage III or IV Heart Failure (HF) with Persistent Congestion and Worsening Renal Function as a Result of Cardiorenal Syndrome (CRS) That Is Resistant to Optimal Medical Therapy Including Loop Diuretics 75
Selective Cytopheretic Device – Adult Use – Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device to Treat ICU Patients with Acute or Chronic Systolic Heart Failure with Cardiorenal Syndrome(CRS) Awaiting Left Ventricular Assist Device (LVAD) Implantation 75
Silmag SA Pipeline Products & Ongoing Clinical Trials Overview 76
Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Status 76
Cuffed Or Non-Cuffed Peritoneal Dialysis Catheter – Product Description 76
Simergent LLC Pipeline Products & Ongoing Clinical Trials Overview 77
Disposable Tubing Set – Product Status 77
Disposable Tubing Set – Product Description 77
Specialty Renal Products Inc Pipeline Products & Ongoing Clinical Trials Overview 78
Dialysate Regeneration Filter System – Product Status 78
Dialysate Regeneration Filter System – Product Description 78
University of California San Francisco Pipeline Products & Ongoing Clinical Trials Overview 79
Implantable Device – Percutaneous AVF – Product Status 79
Implantable Device – Percutaneous AVF – Product Description 79
University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 80
Cold Dialysate Regeneration System – Product Status 80
Cold Dialysate Regeneration System – Product Description 80
University of Rochester Pipeline Products & Ongoing Clinical Trials Overview 81
Nanoporous Membrane Based Hemodialyzer – Product Status 81
Nanoporous Membrane Based Hemodialyzer – Product Description 81
University of Vermont Pipeline Products & Ongoing Clinical Trials Overview 82
Weighted Peritoneal Dialysis Catheter Anchor – Product Status 82
Weighted Peritoneal Dialysis Catheter Anchor – Product Description 82
Vital Access Corp Pipeline Products & Ongoing Clinical Trials Overview 83
Venous Window Access Device – Product Status 83
Venous Window Access Device – Product Description 83
Voyager Biomedical Inc Pipeline Products & Ongoing Clinical Trials Overview 84
ARK – Product Status 84
ARK – Product Description 84
Glossary 116
