Cook Medical treats first patient in first-in-human clinical trial for venous valve

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Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar (Clinica de la Costa, Barranquilla, Colombia).

venous valve
Paul Gagne

The valve’s safety and efficacy are now being tested in a global, multisite clinical trial. The global principal investigator of the study is Paul Gagne (Vascular Care Connecticut, Darien, USA). In addition to being a practicing surgeon and interventionalist, a press release notes that 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 Gagne.

Cook Medical states that CVI affects around 1 in 20 adults. To address this need, the company 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 anaesthesia. It was a team effort to manage this complex case, resulting in the first clinical use of this venous valve,” said Alviar.

The clinical trial will continue to evaluate safety, efficacy, wound healing, leg pain, and disability levels over the next five years.


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