At the beginning of November 2023, Alucent Biomedical announced via press release that it has received a US Food and Drug Administration (FDA) investigational device exemption (IDE) to conduct a US-based clinical study investigating its AlucentNVS technology, which is used to promote “the maturation of arteriovenous fistulas (AVF) in patients requiring haemodialysis”.
Alucent’s goal for this trial—which is already underway and has been enrolling patients in both Poland and Australia—is to “improve the success rate of [AVF] maturation by utilising [this technology] in the surgical AVF creation procedure”. They also added that “this procedure is the gold standard for haemodialysis access for most patients; however, as many as 30–60% of AVFs fail to mature into conduits capable of supporting dialysis”. It aims to do so by combining an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel, in order to control vascular remodelling. This intervention, which is intended to promote patency of the vessel’s lumen and establish sustained improvement of blood flow, is also designed to retain the natural functionality and flexibility of the vascular wall.
Commenting on what the press release refers to as a “milestone,” Alucent’s chief executive officer stated that “this second IDE approval by the FDA will allow us to advance our goal to offer physicians and patients a more successful approach to initiating haemodialysis through an AVF in patients with kidney failure, a life-saving procedure where failure rates are still unacceptably high. We believe our technology has the potential to transform the current standard of care for patients requiring dialysis.”
