Three-Year VeClose Data and 1-Year WAVES Data Presented for Medtronic's VenaSeal Closure System
April 25, 2017—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, 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."
In a separate session at Charing Cross, Dr. Gibson presented the 1-year data from the independent, physician-initiated WAVES study that examined quality-of-life, safety, and effectiveness outcomes with the VenaSeal closure system. The single-center study enrolled 50 patients in a real-world assessment of the treatment of one or more incompetent truncal veins in a single setting without mandatory postoperative compression stockings.
Medtronic summarized the key findings from the WAVES study. The 1-year GSV closure rate for VenaSeal was 100%. In comparison, the GSV closure rate for VenaSeal in VeClose, which required postoperative compression stockings, was 96.8%. Further, the mean vessel diameter in WAVES was larger than in VeClose. The mean time for patients to return to work was 0.2 days ± 1.1 days. The mean time for returning to normal activities, including a patient's exercise routine, was 2.4 days ± 4.1 days, reported the company.
Speaking with Endovascular Today at Charing Cross, Dr. Gibson put the results from both studies into context within the overall superficial venous data landscape. "What all these trials have shown us is that it’s not necessarily the method by which the vein treatment takes place that’s important, it’s the successful application of the technology," she said, highlighting that the VeClose trial showed no difference in outcomes between radiofrequency ablation and VenaSeal. This affords clinicians the opportunity to offer several options and come to an informed, case-specific decision with input from patient and provider alike, noted Dr. Gibson.
Regarding the real world applicability of the favorable data from the IDE setting being shown in the expanded WAVES population, Dr. Gibson commented that the findings reflect the broad applicability of the procedure, as well as an accessible learning curve. Patients treated by experienced and relatively inexperienced operators alike saw improvements in quality of life. With increasing experience, procedure times can be shorter, and, in her own clinic's experience, minor technique variance can lead to greater success in larger veins (though she cautioned that going above 20 mm is pushing the envelope for any technology).
Areas that require further study include the efficacy of nonthermal therapies in ulcer healing and advanced venous disease, as well as perforator treatment and larger segments, which could prove to be additional applications.