Venaseal vein treatment is one of the newest advances in the treatment of varicose veins. Venaseal is a medical grade adhesives administered using ultrasound guidance close off the saphenous veins, which are often the source of large branch varicose veins patients see on the surface of their legs. Venaseal was FDA approved in 2015 with the indication for the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV).
The VenaSeal procedure is the only non-tumescent, non-thermal, non-sclerosant procedure approved for use in the U.S. that uses a specially formulated medical adhesive that closes the vein. This unique approach may eliminate the risk of nerve injury that is sometimes associated with certain thermal-based procedures. The procedure is administered without the use of tumescent anesthesia, minimizing the need for multiple needle sticks. Patients also report minimal-to-no bruising post procedure and in some cases, do not have to wear a compression stocking after the procedure.
The VenaSeal procedure is an office based procedure performed with a single local injection of lidocaine in the skin. It uses a novel technique where a catheter is placed on the inside of the saphenous vein under ultrasound guidance, and advanced up the diseased section of the vein. A surgical adhesive similar to super glue is used to close the vein. With this technique, tumescent anesthesia is not required, nor is compression stockings after the procedure. Because we are not using heat to close the vein, there is minimal risk of skin or nerve injury as a complication of the procedure. Patients can return to work the day of the procedure, and return to regular activity a day or two after the procedure. One consideration is the possibility of an allergy to the glue, which is cyanoacrylate based. Thus, its important to discuss industrial glue exposure and other allergies when considering this procedure.
Clinical Trial Results
The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials. Closure rates in the first clinical trial were 92 percent at 12 and 24 months, respectively. Results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study published in the Journal of Vascular Surgery demonstrate a cumulative closure rate of 92.9 percent and improvement in quality of life scores at 12 months. Additionally, the three month, 12 month and 24 month results of the VeClose pivotal study published in the Journal of Vascular Surgery continue to demonstrate safety and efficacy of the VenaSeal procedure with excellent closure rates of 98.9 percent. As a result of these encouraging clinical trial results, CMS provided reimbursement to cover this procedure for medicare patients, and it is expected that many private health insurance companies will follow in the coming years. In these studies Venaseal was compared to Closurefast. The main difference is that compared to Closurefast there is less need for needlesticks for anesthesia during the procedure, and thus patients report its more comfortable and they have less bruising in early recovery. Over time, however, the results are quite similar to Closurefast.
The Inovia Venaseal Vein Treatment Experience
We were the first clinic in Oregon to perform Venaseal. As reported in the Bend, Bulletin, in 2013, our first patient described the 20 minute procedure as painless, other than the needlestick to put in the local anesthetic: “It was maybe 30 seconds of pain and it was minimal. Then there was just a bit of discomfort because you can kind of sense some tugging as they go up your leg,” she said. “I can’t tell you how slick and easy it was.” We went on to participate in the original VeClose pivitol trial where we enrolled the second largest number of patients in the trial. We are still following these patients 5 years later. As an investigator and author of the study, Dr. Jones has been invited to present this data and numerous national and international meetings. In addition, doctors have traveled from all over the country and world to observe how we do this procedure as part of their training to offer this exciting technology to their patients.
One of the advantages of coming to Inovia is that we offer nearly all of the latest, most innovative varicose vein treatments. We can assess your particular situation, offer you options, and let you decide which treatment is best for you.
You can find out if Venaseal is right for you. We are currently scheduling patients in our clinic at The Center next to St. Charles Medical Center (which serves Oregon patients from Bend, Redmond, Prineville, Madras, La Pine, Baker City, Burns, and John Day) and scheduling patients for our clinic at the Bridgeport Village Center in Tigard, Oregon (for Oregon patients from Portland, Tigard, Lake Oswego, West Linn, Hillsboro, Beaverton, Sherwood, Tualatin, Wilsonville, Clackamas, Sunnyside, and Milwaukie).