Cook Medical today announced the first patient treated in a study evaluating its new venous valve for treating chronic venous insufficiency.
Dr. Mauricio Alviar, a principal investigator, treated the first patient in the clinical study. Alviar serves as a vascular surgeon at Clinica de la Costa in Barranquilla, Colombia. Deployment took a few minutes, Alviar noted, and the patient had local anesthesia.
Bloomington, Indiana-based Cook Medical said it’s now testing the valve’s safety and efficacy in a global, multi-site clinical trial. Dr. Paul Gagne of Vascular Care Connecticut serves as global principal investigator. This trial evaluates the safety, efficacy, wound healing, leg pain and disability levels over five years.
“When leg veins function poorly, patients suffer with leg swelling, leg pain, leg ulcers, disability, and possible amputation,” Gagne said. “Therefore, it is important to restore blood flow out of the leg veins, back to the heart. Part of doing this successfully requires restoring the function of the venous valves.”
Cook Medical designed its valve that functions similarly to the way the veins naturally work. Its novel, proprietary artificial valve design mimics native venous valves, according to a news release.
“First-in-human clinical trials are exciting. They are a milestone in treating patient populations with unmet needs,” said Mark Breedlove, SVP of Cook Medical’s Vascular division. “This first patient enrollment is a proof point of our commitment to innovation and finding unique ways to treat debilitating conditions like CVI.”