Cook Medical announces the first patient treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency. The patient was treated by Dr. Mauricio Alviar, vascular surgeon and principal investigator, of Clinica de la Costa in Barranquilla, Colombia.
The valve’s safety and efficacy are now being tested in a global, multi-site clinical trial. The global principal investigator of the study is Dr. Paul Gagne, a vascular surgeon from Vascular Care Connecticut. In addition to being a practicing surgeon and interventionalist, Dr. Gagne brings significant experience in performing clinical trials of minimally invasive vascular medical devices.
“When leg veins function poorly, patients suffer with leg swelling, leg pain, leg ulcers, disability, and possible amputation. 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,“ said Dr. Gagne.
In chronic venous insufficiency (CVI), a patient’s blood vessels in the lower limbs do not effectively pump blood back to the heart. The valves in the leg veins can become damaged and become less effective. CVI affects around 1 in 20 adults.[1]
To address this need, Cook Medical and Cook Advanced Technologies developed a valve that functions similar to the way the veins naturally work. The artificial valve is a novel proprietary design that mimics native venous valves.
“After extensive ultrasonic and venographic evaluation of venous anatomy, we placed the Cook Medical venous valve in the leg vein. The deployment took a few minutes and the patient had local anesthesia. It was a team effort to manage this complex case, resulting in the first clinical use of this venous valve,” said Dr. Alviar.
“First-in-human clinical trials are exciting. They are a milestone in treating patient populations with unmet needs,” said Mark Breedlove, senior vice president 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.”
The clinical trial will continue to evaluate safety, efficacy, wound healing, leg pain and disability levels over the next five years.
To learn more about how Cook is innovating solutions for patients with venous conditions, visit cookmedical.com/peripheral-intervention.