Five-year data from a study of the ClosureFast device Medtronic (NYSE:MDT) acquired along with Covidien last month showed strong safety and efficacy profiles for the technology, which uses radiofrequency ablation to treat chronic venous insufficiency.
CVI occurs when valves in the veins of the lower leg no push blood back to the heart, allowing blood to flow backwards and enlarge the veins. The ClosureFast device is designed to seal the abnormal GSV to re-route blood to other veins, Medtronic said.
Results from the 225-patient study, published this month in the British Journal of Surgery, showed a greater saphenous vein occlusion rate of 91.9% after 5 years and a reflux-free GSV rate of 94.9%.
"RFA maintains occlusion rates of more than 90% and freedom from reflux in 95% of legs after 5 years," the researchers wrote. "RFA is an effective and durable treatment for great saphenous varicose veins. Comprehensive follow-up for other methods to 5 years is required to establish the optimal treatment for varicose veins.”
Medtronic landed the ClosureFast tech when it paid $50 billion last month for Covidien, which itself acquired it for $440 million from VNUS Medical Technologies in mid-2009.
“Refluxing saphenous veins are a major reason to develop clinical symptoms of CVI. As a progressive disease, it is important for patients to evaluate treatment options that demonstrate long-term effectiveness of the procedure given the chance of reoccurrence," Dr. Thomas Proebstle of Germany’s University Medical Center Mainz said in prepared remarks. "The results of the ClosureFast five-year study provide physicians and patients with additional confidence of the effectiveness of the procedure and durability of the outcomes."
"The publication of the long-term ClosureFast data in the British Journal of Surgery further supports our commitment to providing physicians and patients with clinical data supporting our technologies," added Medtronic’s aortic & peripheral vascular medical director Dr. Mark Turco. "The ClosureFast catheter is the only minimally invasive treatment with long-term results demonstrating its sustained success in treating patients with CVI."