Several scientific presentations were made at the American Venous Forum (AVF) meeting at Loew’s Coronado in San Diego, California, including excellent five-year follow-up results from a multi-centre clinical registry of the Closure procedure. The Closure procedure, an endovenous radio frequency treatment, is a leading minimally-invasive treatment for venous reflux disease, a common underlying cause of painful varicose veins.
Dr Robert Merchant presented five-year multi-center results demonstrating that 84% of 117 limbs treated with the Closure procedure were absent of venous reflux. This data complements recently published four-year data demonstrating 86% success at eliminating venous reflux in 98 limbs. Merchant’s presentation was the first US presentation of five-year follow-up data for any endovenous treatment of venous reflux disease.
Merchant also reported results from a large multi-center international registry indicating that of 1,078 limbs treated, 89% of veins remained occluded at four-year follow-up. Patient symptom relief was also pronounced and durable long-term; patients reported experiencing pain in 85% of limbs prior to treatment, versus only 5% at four-year follow-up. Data collected in this ongoing multi-centre prospective registry was from 32 centres, with four-year results from 12 centres. In particular this study specifically demonstrated that veins larger than 12mm had treatment results similar to those with a diameter of 12mm or less.
Other presentations highlighted additional successes of the Closure procedure. Dr Steven Gale, reported a 93% success rate at achieving vein occlusion in 27 limbs and a 100% patient satisfaction rate shortly after treatment of the small saphenous vein with the Closure procedure. In addition, Dr Daniel Monahan, presented a study examining whether varicose veins resolve or decrease in size following saphenous vein ablation alone. Monahan reported that 62% of varicose veins required no adjunctive treatment due to spontaneous resolution or decrease in size during six-month follow-up, when treated with the Closure procedure alone, helping to establish a basis for the development of future patient treatment strategies.
Dr Enrico Ascher, and his group reported that radio frequency ablation of the great saphenous vein for superficial venous reflux can help correct deep venous reflux. In 100 limbs studied, popliteal vein (deep venous system) reflux decreased from 65% to 25% following the Closure procedure. This study indicates the benefit of the Closure procedure to patients with multiple reflux sources.
A randomised trial from Germany reported by Dr Lorenz Stoetter compared the Closure procedure, traditional vein stripping and cryo-stripping. Closure procedure patients experienced less pain and discomfort at one week after treatment, and also reported greater satisfaction and better cosmetic outcomes 12 months after treatment compared to patients treated by the other two methods. This is the third randomised trial of the Closure procedure versus traditional surgery to demonstrate similar results, demonstrating positive outcomes for patients treated with the Closure procedure compared to vein-stripping surgery.
VNUS Medical Technologies, Inc., the developer of products for the minimally-invasive treatment of venous disease, currently markets the proprietary Closure System for patients who suffer from symptoms associated with venous reflux.