Here is the Three Year Closure Rate for VenaSeal
Medtronic announced 3-year outcomes from the VeClose United States pivotal clinical trial and 1-year data from the WAVES study, which were presented by Kathleen Gibson, MD, at the 2017 Charing Cross Symposium in London, United Kingdom. The company stated that the new data demonstrate the clinical and quality-of-life benefits of the VenaSeal closure system (Medtronic) in treating patients with venous reflux disease.
Medtronic stated that the VenaSeal closure system is a nontumescent, nonthermal, nonsclerosant procedure that uses a medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux.
The VeClose United States pivotal clinical trial is a prospective randomized controlled trial comparing the safety and effectiveness of the VenaSeal closure system to the ClosureFast endovenous radiofrequency ablation system (Medtronic) in a noninferiority design. The trial enrolled 242 patients with symptomatic refluxing GSVs, of which 222 were randomized 1:1 to receive treatment with VenaSeal or ClosureFast.
At 3 years, complete closure of the GSV was achieved in 94.4% of patients treated with VenaSeal compared to 91.9% of patients treated with ClosureFast, showing both the continued long-term, noninferior outcomes (P = .005) and the durability of the treatment.
Additionally, the patient improvement was rated on three assessments: Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire, and EQ-5D. In all three assessments, patients treated with either VenaSeal or ClosureFast showed statistically significant improvement from baseline.
In the company's press release, Dr. Gibson commented, "The 3-year outcomes for this randomized trial reinforce the consistent clinical performance of VenaSeal and ClosureFast. These long-term VenaSeal data along with postmarket WAVES study results continue to build on the prior findings for this innovative treatment option for venous reflux disease, demonstrating safety, effectiveness, and quality of life."