Cook Medical Begins First-In-Human Clinical Trial for Venous Valve

April 28, 2023—Cook Medical announced that the first patient was treated in a clinical study of the company’s new venous valve designed for treating chronic venous insufficiency.

The artificial valve was developed by Cook Medical and Cook Advanced Technologies and designed to mimic native venous valves.

The global, multicenter clinical trial will evaluate the device’s safety and efficacy, including wound healing, leg pain, and disability levels over 5 years.

Paul Gagne, MD, is the study’s global Principal Investigator. Dr. Gagne is a vascular surgeon at Vascular Care Connecticut in Darien, Connecticut.

“When leg veins function poorly, patients suffer with leg swelling, leg pain, leg ulcers, disability, and possible amputation,” commented Dr. Gagne in Cook’s press release. “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.”

The study’s first patient was treated by vascular surgeon Mauricio Alviar, MD, who is the study Principal Investigator at Clinica de la Costa in Barranquilla, Colombia.

Dr. Alviar stated in the press release, “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.”