Medtronic (NYSE:MDT) touted 3-year outcomes from a pivotal clinical trial and 1-year data from the Waves study of its VenaSeal closure system in patients with venous reflux disease. Dr. Kathleen Gibson, from Lake Washington Vascular, presented the data at the 2017 Charing Cross Symposium.
Both studies demonstrated long-term clinical benefits and improvement in quality of life for patients treated with VenaSeal, according to the Fridley, Minn.-based company.
The VenaSeal system from Medtronic uses a proprietary medical adhesive to close superficial veins in lower extremities in patients with symptomatic venous reflux, or varicose veins.
In the VeClose U.S. pivotal clinical trial, 242 patients with symptomatic refluxing great saphenous veins were randomized to receive treatment with the VenaSeal closure system or Medtronic’s ClosureFast endovenous radiofrequency ablation procedure.
After 3 years, complete closure of the great saphenous veins was achieved in 94.4% of patients treated with VenaSeal compared to 91.9% of patients treated with ClosureFast, demonstrating non-inferiority and durability, Medtronic reported. Patients treated with either VenaSeal or ClosureFast also reported statistically significant improvement in quality of life compared to baseline.
“The 3-year outcomes for this randomized trial reinforce the consistent clinical performance of VenaSeal and ClosureFast,” Dr. Gibson said in prepared remarks. “These long-term VenaSeal data along with post-market 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.”
The company’s Waves trial enrolled 50 patients in a real-world assessment of the treatment of 1 or more incompetent truncal veins in a single setting, without mandatory post-operative compression stockings. The 1-year great saphenous vein closure rate was 100% for VenaSeal. The data also showed that patients were able to return to work in less than 1 day, on average.
“The data presented at Charing Cross further demonstrate the VenaSeal closure system as a safe and effective therapy for treating venous reflux disease,” Sandra Lesenfants, VP & GM of the Medtronic’s endovenous business, said. “Together with the clinical community, we look forward to continuing our investment in clinical research to support the use of this innovative, minimally invasive treatment for venous reflux disease.”