Michael Barbella, Managing Editor01.30.24
Alucent Biomedical Inc. has been granted an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to conduct a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas (AVF) in patients requiring hemodialysis. This milestone follows Alucent’s first IDE approval from the FDA, granted last year.
AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in a blood vessel wall to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improved blood flow. AlucentNVS is also designed to retain the vascular wall's natural functionality and flexibility.
The company aims to improve AV fistula maturation success rate by using its AlucentNVS technology in the surgical AVF creation procedure. This procedure is the gold standard for hemodialysis access for most patients; however, as many as 30% to 60% of AVFs fail to mature into conduits capable of supporting dialysis.
“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,” Alucent Biomedical CEO Dr. Myles Greenberg said. “We believe our technology has the potential to transform the current standard of care for patients requiring dialysis.”
The Activate AVF feasibility trial is already underway and enrolling patients at sites in Australia and Poland.
Alucent Biomedical Inc. is a privately held company developing and commercializing its AlucentNVS technology for treating patients requiring life-saving vascular procedures. Alucent Biomedical was founded in 2017 by the Avera Research Institute, part of the multistate Avera Health System.
AlucentNVS combines an intravascular device with a photochemical process to link structural proteins in a blood vessel wall to control vascular remodeling. The intervention is designed to promote patency of the vessel’s lumen and establish sustained improved blood flow. AlucentNVS is also designed to retain the vascular wall's natural functionality and flexibility.
The company aims to improve AV fistula maturation success rate by using its AlucentNVS technology in the surgical AVF creation procedure. This procedure is the gold standard for hemodialysis access for most patients; however, as many as 30% to 60% of AVFs fail to mature into conduits capable of supporting dialysis.
“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,” Alucent Biomedical CEO Dr. Myles Greenberg said. “We believe our technology has the potential to transform the current standard of care for patients requiring dialysis.”
The Activate AVF feasibility trial is already underway and enrolling patients at sites in Australia and Poland.
Alucent Biomedical Inc. is a privately held company developing and commercializing its AlucentNVS technology for treating patients requiring life-saving vascular procedures. Alucent Biomedical was founded in 2017 by the Avera Research Institute, part of the multistate Avera Health System.