Clinical Data

Bioconnect's initial human clinical results have been favorable. Data from initial human implants of the Optiflow were presented at the 2009 American Society of Nephrology Meeting by Prabir Roy-Chaudhury, MD, PhD, Associate Professor of Medicine, Dept of Nephrology, University of Cincinnati.

Additional studies are currently being conducted.

Optiflow™: Arteriovenous Fistula (AVF) Creation using the Optiflow Vascular Anastomosis Device

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Prabir Roy-Chaudhury,1 Roberto Manson,2 Mark Mantell,3 Adrian Ebner4

Cincinnati Dialysis Access Program (CAP), University of Cincinnati and Cincinnati VAMC1; Duke University2; University of Pennsylvania3; Hospital Privado Frances4


Introduction


AV Fistula non-maturation is currently a huge clinical problem with a very significant morbidity and economic cost. The most common cause of AV fistula non-maturation is the early and aggressive occurrence of a peri-anastomotic stenosis. The Optiflow device is an anastomotic implant that has the potential of shielding the peri-anastomotic region.

The Objective of this study was to evaluate the technical feasibility, safety, and clinical success of the Optiflow implant for creation of an arteriovenous fistula.


Methods


  • End to side Radial-Cephalic, Brachial-Cephalic, and Brachial-Basilic fistulas were created using the Optiflow Implant (3mm or 4mm) in 10 patients
  • The conduit of the Optiflow Implant was secured inside a transected vein and the flanges were placed inside a punched arteriotomy (Fig 2)
  • Primary safety endpoint was freedom from severe and unanticipated adverse events at day 42
  • Primary efficacy endpoint was technical success following the procedure
  • Secondary efficacy endpoint was primary patency at 42 days as confirmed by clinical exam and ultrasound


Figure 1: Optiflow™ Implant
figure 1 Figure 2: Optiflow anastomosis intra-op
figure 2 Figure 3: Follow-up ultrasound
figure 3



Results


  • Mean patient age was 45 yrs (+/- 12.2 years)
  • 6 male and 4 female patients enrolled in the study
  • Technical success achieved for all 10 patients
  • No severe or unanticipated adverse events
  • 90% primary patency achieved at 42 days
  • All vein diameters at day 42 exceeded the minimum 6mm diameter specified in the DOQI guidelines – Figure 6
  • One patient had a pseudoaneurysm prior to day 21 which was attributed to an accident during cannulation. This patients fistula was patent at day 42
  • Early cannulation (prior to day 21) performed on 2 patients
  • Subjective surgical assessment suggested excellent immediate dilation and reduction of time compared to historical controls


Figure 4: Fistula (42 Days)
figure 4 Figure 5: Fistula (42 Days)
figure 5 Figure 6: Vein maturation at 42 Days
figure 6



Conclusions


  • This clinical study suggests that the Optiflow implant is a safe and effective means to create an arteriovenous fistula.
  • The Optiflow device could be an important adjunct for AV Fistula maturation in the dialysis population; resulting in reduced costs and an improvement in patient care.
Optiflow™ is under investigation and not available for sale.