Medtronic's 5-Year ClosureFast Study Results Published

February 10, 2015—Medtronic plc announced that data demonstrating that the company’s ClosureFast endovenous radiofrequency ablation catheter is safe and effective for the treatment of chronic venous insufficiency (CVI) over 5 years were published by Professor Thomas Proebstle, MD, et al in the British Journal of Surgery (2015;102;212–218). The results of the ClosureFast long-term European multicenter study demonstrate the durability of the device, with strong closure rates of the great saphenous vein and minimal treatment side effects at 5 years.

The ClosureFast catheter uses segmental radiofrequency ablation to seal off and close the abnormal saphenous vein to reroute blood to other veins. This procedure is associated with lower rates of pain, bruising, and complications and more rapid improvement in patients’ quality of life, stated Medtronic.

According to Medtronic, the study was conducted prospectively at eight centers in Europe. The ClosureFast catheter was used to treat 295 limbs in 225 patients diagnosed with superficial venous reflux. Saphenous vein closure was sustained in 96.3%, 92.6%, and 91.9% of limbs during follow-up at 1, 3, and 5 years, respectively. Additionally, the reflux-free rates were 99%, 95.7%, and 94.9% at 1, 3, and 5 years.

Investigators also utilized the Venous Clinical Severity Score to evaluate patient symptoms such as pain, skin pigmentation, swelling, and ulcers. Patients treated with the ClosureFast catheter improved from a baseline score of 3.9 to a score of 1.3 at 5 years, indicating that these patients went from experiencing severe symptoms of CVI to mild symptoms at 5 years.

In Medtronic’s press release, Prof. Proebstle commented, “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. The results of the ClosureFast 5-year study provide physicians and patients with additional confidence of the effectiveness of the procedure and durability of the outcomes.” Prof. Proebstle is with the Department of Dermatology at the University Medical Center Mainz in Germany.

Medtronic advised that the ClosureFast system is approved in approximately 90 markets including the United States, Europe, Brazil, Russia, Japan, and India.