Sam Brusco, Associate Editor08.02.23
Alucent Biomedical has been granted a U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) to initiate a U.S. clinical study for it AlucentVNS light-activated, drug-coated balloon (DCB) catheter study.
AlucentVNS is an intravascular device with a photochemical process to link structural proteins in the blood vessel wall to control vascular remodeling. The procedure aims to promote vessel lumen patency and establish sustained blood flow improvement.
The tech was also engineered to keep the vascular wall’s natural functionality and flexibility, while avoiding traditional complications of inserting permanent implants, according to the company.
“IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” Dr. Myles Greenberg, CEO of Alucent told the press. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and limb-saving vascular procedures.”
AlucentVNS is being assessed in two feasibility trials in Australia and Poland to treat peripheral artery disease (PAD) and promoting maturation of arteriovenous fistulas (AVF) for patients needing hemodialysis. The company said enrollment in the trials is expected to finish by the end of 2023.
Alucent Biomedical was founded by the Avera Research Institute, part of the multistate Avera Health System, in 2017.
AlucentVNS is an intravascular device with a photochemical process to link structural proteins in the blood vessel wall to control vascular remodeling. The procedure aims to promote vessel lumen patency and establish sustained blood flow improvement.
The tech was also engineered to keep the vascular wall’s natural functionality and flexibility, while avoiding traditional complications of inserting permanent implants, according to the company.
“IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” Dr. Myles Greenberg, CEO of Alucent told the press. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and limb-saving vascular procedures.”
AlucentVNS is being assessed in two feasibility trials in Australia and Poland to treat peripheral artery disease (PAD) and promoting maturation of arteriovenous fistulas (AVF) for patients needing hemodialysis. The company said enrollment in the trials is expected to finish by the end of 2023.
Alucent Biomedical was founded by the Avera Research Institute, part of the multistate Avera Health System, in 2017.