title: Clinical safety and performance of VIVIA: a novel home hemodialysis system.
abstract: The VIVIA Hemodialysis System (Baxter Healthcare Corporation, Deerfield, IL, USA) was designed for patient use at home to reduce the burden of treatment and improve patient safety. It has unique features including extended use of the dialyzer and blood set through in situ hot-water disinfection between treatments; generation of on-line infusible-quality dialysate for automated priming, rinseback and hemodynamic support during hypotension and a fully integrated access disconnect sensor.
  
  
  
  The safety and performance of VIVIA were assessed in two clinical studies. A first-in-man study was a prospective, single-arm study that involved 22 prevalent hemodialysis (HD) patients who were treated for ∼4 h, four times a week, for 10 weeks. A second clinical study was a prospective, single-arm study (6-8 h of dialysis treatment at night three times a week) that involved 17 prevalent patients treated for 6 weeks.
  
  
  
  There were 1114 treatments from the two studies (first-in-man study, 816; extended duration study, 298). Adverse events (AEs) were similar in the two studies to those expected for prevalent HD patients. No deaths and no device-related serious AEs occurred. Adequacy of dialysis ( Kt / V ) urea in both clinical trials was well above the clinical guidelines. VIVIA performed ultrafiltration accurately as prescribed in the two studies. The majority of patients achieved 10 or more uses of the dialyzer. Endotoxin levels and bacterial dialysate sampling met infusible-quality dialysate standards.
  
  
  
  These results confirm the safety and expected performance of VIVIA.
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Angelito A
authors.initials: AA
authors.lastname: Bernardo
authors.affiliation: Orlando Clinical Research Center, Orlando, FL, USA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Marbury
authors.affiliation: St. Michael's Hospital, Toronto, ON, Canada.
authors.forename: Phil A
authors.initials: PA
authors.lastname: McFarlane
authors.affiliation: University of Alberta Hospital, Edmonton, AB, Canada.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Pauly
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Amdahl
authors.affiliation: DEKA Research & Development Corporation, Manchester, NH, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Demers
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Audrey M
authors.initials: AM
authors.lastname: Hutchcraft
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: John K
authors.initials: JK
authors.lastname: Leypoldt
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Minkus
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Matt
authors.initials: M
authors.lastname: Muller
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Stallard
authors.affiliation: Baxter Healthcare Corporation (DF5-1N), One Baxter Parkway, Deerfield and Round Lake, IL, USA.
authors.forename: Bruce F
authors.initials: BF
authors.lastname: Culleton
mesh_terms: D005260:Female; D006437:Hemodialysis, Home / Q000295:instrumentation* / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic; D011446:Prospective Studies; D012449:Safety; D014508:Urea / Q000097:blood*
chemical_list: D014508:Urea
keywords: VIVIA; dialysate for infusion; extended use; heat disinfection; home hemodialysis