US FDA Grants an Investigational Device Exemption for Trial Evaluating Novel AlucentNVS Technology
Alucent gets FDA nod US Clinical trial. (Credit: valelopardo from Pixabay)
Alucent Biomedical today announced that the US Food & Drug Administration granted an Investigational Device Exemption (IDE) for a US clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
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, while avoiding traditional complications of inserting permanent implants.
“IDE approval by the FDA’s Division of Coronary and Peripheral Interventional Devices is another validation of our novel approach to treating vascular disease,” said Dr. Myles Greenberg, CEO of Alucent Biomedical. “AlucentNVS technology is poised to change the standard of care in treating patients undergoing life- and limb-saving vascular procedures.”
AlucentNVS is currently being evaluated in two feasibility trials in Australia and Poland, also examining its use in treating peripheral artery disease (PAD) and promoting the maturation of arteriovenous fistulas (AVF) for patients requiring hemodialysis. Enrollment in those trials is expected to conclude by the end of 2023.
Source: Company Press Release