Alucent Receives IDE for Trial of AlucentNVS in Promoting AVF Maturation

November 30, 2023—Alucent Biomedical Inc. recently announced that the FDA granted an investigational device exemption (IDE) for a United States clinical study of AlucentNVS, a natural vascular scaffolding device, for promoting the maturation of arteriovenous fistulas (AVFs) in patients requiring hemodialysis. The company aims to improve the success rate of AVF maturation by using its AlucentNVS technology in the surgical AVF creation procedure.

In August, the company received its first IDE approval from the FDA for the AlucentNVS, for treatment of vascular disease.

“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 hemodialysis through an AVF in patients with kidney failure, a life-saving procedure where failure rates are still unacceptably high,” commented Alucent’s CEO Myles Greenberg, MD, in the company’s press release. “We believe our technology has the potential to transform the current standard of care for patients requiring dialysis.”

The ACTIVATE AVF safety and feasibility study of AlucentNVS for AVF in patients with end-stage renal disease is enrolling patients at sites in Australia and Poland.

In January 2023, the company announced the commencement of patient enrollment in ACTIVATE AVF.

In April 2022, Alucent announced enrollment of the first patient in the ACTIVATE II first-in-human clinical trial evaluating the safety and efficacy of AlucentNVS for vessel lumen restoration and sustained improvement of blood flow.

According to the company, AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in the wall of a blood vessel to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improvement of blood flow. AlucentNVS is also designed to retain the natural functionality and flexibility of the vascular wall.