Five year safety results from Closure Fast ablation catheter for Chronic Venous Insufficiency published in Brit. Journal of Surgery- Medtronic/Covidien

The ClosureFast endovenous radiofrequency ablation catheter from Medtronic plc is safe and effective for the treatment of chronic venous insufficiency (CVI) over five years, according to data published in the February 2015 issue of British Journal of Surgery. The five-year results of the ClosureFast Long-Term European Multi-Center Study demonstrate the durability of the device, with strong closure rates of the great saphenous vein and minimal treatment side effects at five years.

Saphenous vein closure was sustained in 96.3 percent, 92.6 percent, and 91.9 percent of limbs at one, three and five years follow-up, respectively. Additionally, the reflux-free rates (blood flowing backwards in the vein) were 99 percent, 95.7 percent, and 94.9 percent at one, three and five years.

Investigators also utilized Venous Clinical Severity Scores (VCSS) 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 1.3 score at five years. These results demonstrate that patients in the study went from experiencing severe symptoms of CVI to mild symptoms at five years.

Comment: Covidien/Medtronic reports that 95% of patients were free of venous reflux after 5 years following the ClosureFast Long-Term European Multi-Center Study in patients with Chronic Venous Insufficiency (CVI), compared to 99% after one year.