VenoStent has announced successful enrolment in its initial feasibility clinical trial. The clinical trial is testing the safety and efficacy of its 3D-printed bioabsorbable wraps in humans—a new methodology to improve surgical outcomes for haemodialysis patients.
Enrolment was completed for the initial VenoStent feasibility study in Asunción, Paraguay involving 20 end-stage renal disease (ESRD) patients that were referred for creation of an arteriovenous fistula (AVF) to enable haemodialysis treatments.
The participants in the study are followed up for several months and, according to a VenoStent press release, the team has already seen highly encouraging safety and performance signals—which could indicate much greater clinical outcomes and quality of life for kidney disease patients when treated with the VenoStent SelfWrap bioabsorbable perivascular wrap technology.
Tim Boire, VenoStent CEO, said: “After years of development, we are confident that our bioabsorbable wrap technology can have a positive impact on the lives of patients that require haemodialysis to sustain life. This is a major milestone toward our mission to improve the quality and length of life for end-stage renal disease patients, as well as others needing vascular surgery.”
VenoStent’s proprietary scaffold is designed to solve the issue of reduced/blocked flow (caused by neointimal hyperplasia) in the blood vessels being used for haemodialysis access by aiding the arterialisation process at the time of vascular surgery.
The release also notes that successful enrolment in this initial feasibility trial is set to support future regulatory submissions from VenoStent.