The pivotal, multicenter trial commissioned by Envveno Medical Corp. is intended to show its first-in-class Venovalve implant is safe and effective for treating deep venous chronic venous insufficiency (CVI), which occurs when damaged valves inside the veins of the leg prevent blood from flowing up the leg and into the heart and lungs.

Jorge Ulloa of Hancock Jaffe Laboratories Inc. presented positive results from a first-in-human trial of implantation with its Venovalve device at the Society for Vascular Surgery annual meeting in San Diego. Two years following surgery, outcomes included more than 60% improvements in reflux and disease manifestations and 93% decrease in pain in patients with chronic venous insufficiency with no safety issues or venous ulcer recurrences.

The FDA granted an investigational device exemption (IDE) to Hancock Jaffe Laboratories Inc. for Venovalve, clearing the way for the company to begin a pivotal trial of the implantable valve in patients with chronic venous insufficiency (CVI) of the deep veins of the leg. The company’s first patent covering the device was issued by the U.S. Patent and Trademark Office on April 7.