Business
enVVeno Medical Reports Successful Completion of First VenoValve Surgery for U.S. Pivotal Trial
75 Patient Trial Underway to Evaluate Safety and Efficacy of the VenoValve as a Potential Treatment for Severe Deep Venous Chronic Venous Insufficiency
About this update from Envveno Medical Corporation
[{"type":"text","content":"75 Patient Trial Underway to Evaluate Safety and Efficacy of the VenoValve as a Potential Treatment for Severe Deep Venous Chronic Venous Insufficiency (CVI)Severe CVI Impacts Approximately 2.4 million U.S. Patients with No Current Effective Treatment OptionsIRVINE, CA / ACCESSWIRE / October 22, 2021 / enVVeno Medical Corporation (NASDAQ:NVNO) (\"enVVeno\" or the \"Company\"), a company setting new standards of care for the treatment of venous disease, today announced that the first VenoValve surgery in the Company's SAVVE U.S. pivotal trial for the VenoValve® has been successfully completed. The surgery was performed by Dr. Adriana Laser, associate professor of surgery at Albany Medical College and a vascular surgeon with Albany Med Vascular Surgery. The patient has been discharged from the hospital.\"It is an honor to be the first surgeon in the U.S. to implant a device which has the potential to help the millions of people that suffer from the debilitating impacts of Chronic Venous Insufficiency,\" said Dr. Laser. \"Although the name Chronic Venous Insufficiency may not be familiar to the general public, deep venous CVI has been frustrating the vascular community and our CVI patients for decades, and we are hopeful that the VenoValve will be the first safe and effective treatment option for the disease.\"The VenoValve is intended to restore proper directional blood flow for patients with CVI of the deep veins of the leg. CVI occurs when natural valves inside of the veins fail, causing blood to flow in the wrong direction (reflux), and creating increased pressure inside of the veins of the leg (venous hypertension). CVI can cause the leg to swell, and blood vessels to break, resulting in discoloration, pain, and the breakdown of the skin leading to venous ulcers (open sores) which are difficult to treat.\"Today marks a historical milestone for our Company, having had the first patient treated in the SAVVE U.S. pivotal trial for the VenoValve\", said enVVeno Medical CEO Robert Berman. \"We would like to thank Dr. Laser for agreeing to be a part of our study and for treating the first patient\".The SAVVE (Surgical Anti-reflux Venous Valve Endoprosthesis) U.S. pivotal trial is a prospective, non-blinded, single arm, multi-center trial designed to evaluate the safety and efficacy of the VenoValve to improve lower leg blood flow, a...