Safety and Efficacy of Electrospun Polycarbonate-Urethane Vascular Graft for Early Hemodialysis Access: First Clinical Results in Man

Abstract

The electrospun polycarbonate-urethane graft is safe in humans, permits early access obviating the need for venous catheters, and has equivalent patency to other prosthetic grafts at 1 year.

In Pursuit of Functional Electrospun Materials for Clinical Applications in Humans

“…Its composition and form is hypothesized to be more biocompatible, which is expected to increase patency rates due to lower graft stenosis, and exhibit shorter times for cannulation due to better resealing properties [13]. However, a clinical study of AVflo showed that patency rates were similar to values reported for ePTFE grafts [14]. Future clinical studies will need to measure the advantage of shortened cannulation time for AVflow compared with existing grafts given that patency rates were not improved si gnificantly.…”

“…AVFlow TM (Nicast) [13,14] Polyurethane Composite vascular graft Implant PK Papyrus (Biotronik) [12] Polyurethane Coating metal stent Implant…”

Elastomagnetic nanofiber wires by magnetic field assisted electrospinning

“…Furthermore, the PCU was chosen because it is widely used for the fabrication of implantable devices (i.e. vascular grafts, artificial heart components) [38,39] and for all the biomedical applications that require high biocompatibility and a superior mechanical response in terms of elongation, flexibility, and chemical stability under aggressive microenvironments [40]. This is due to the presence of strong intermolecular bonds with polycarbonate polyol, which makes them highly resistant to biodegradation and hydrolysis [41].…”

In vivo safety evaluations of electrospun nanofibers for biomedical applications

“…The AVflo is a CE-certified electrospun nanofibrous-based polyurethane vascular access graft developed by Nicast Ltd, Israel, which is currently available in Asian countries, European Union market, and Israel [15]. The clinical trial studies of AVflo were conducted in patients and well reported [16]. The company is in further progress of developing nanofiber-based products such as nanostructured bioactive small-diameter vascular graft, biodegradable implant toward a better therapy for visual sensory impairments, biomimetic nanofiber-based nucleus pulposus regeneration for the treatment of degenerative disk disease, and NovaMesh Ventral Hernia Mesh.…”