Medtronic’s VenaSeal closure system has been granted pre-market approval (PMA) from the US Food and Drug Administration (FDA) for the treatment of symptomatic venous reflux.
This minimally invasive procedure is the first and only non-tumescent, non-thermal, non-sclerosant procedure approved for this purpose, according to Medtronic. The VenaSeal system is designed to close superficial veins of the lower extremities, such as the great saphenous vein, with a proprietary medical adhesive, in patients with symptomatic venous reflux.
“Patients are often told their varicose veins are only a cosmetic issue, but varicose veins are a sign of venous insufficiency,” explains Kathleen Gibson, Lake Washington Vascular, Seattle, USA. On the 21 October 2015, Gibson performed the first treatment of a US patient with the VenaSeal system since its approval.
“The first patient is an active, tennis-playing mother of three with a family history of varicose veins. After careful diagnosis and evaluation of various treatment options, she and I decided VenaSeal was the right choice of treatment for her. She reported no pain during the procedure and was able to return to normal activities quickly after the treatment. She left the office with a single adhesive bandage at the site of treatment, and without post-procedure compression stockings,” says Gibson.
This approach is designed to eliminate the risk of burning or nerve injury that is sometimes associated with thermal-based procedures. The procedure is administered without the use of tumescent anaesthesia, minimising the need for multiple needle sticks. In the VeClose trial, patients reported minimal-to-no pain or bruising post procedure.
“The VenaSeal procedure is shown to be safe and effective, with consistent results across three clinical trials,” says Nick Morrison, national principal investigator of the VeClose Trial, Morrison Vein Institute, Scottsdale, USA. “One-year results of the VeClose pivotal study, that led to the approval of VenaSeal closoure system in the USA, continue to demonstrate safety and efficacy of the procedure, with closure rates of 97.2%.”