Five-year ClosureFast study results published - results demonstrate durability, effectiveness of treatment for chronic venous insufficiency

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 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.

The ClosureFast catheter is the only treatment that uses segmental radiofrequency ablation to seal off and close the abnormal saphenous vein so blood gets re-routed to other veins. This minimally invasive procedure is associated with lower rates of pain, bruising and complications and more rapid improvement in patients' quality of life.ⁱ

"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," said Prof. Thomas Proebstle, M.D., PhD, Dept. of Dermatology, University Medical Center Mainz, Germany. "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 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, the underlying cause of varicose veins and CVI. Saphenous vein closure was sustained in 96.3 percent, 92.6 percent,ⁱⁱ 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,2 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.

"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," said Dr. Mark Turco, medical director for the Aortic and Peripheral Vascular business at Medtronic. "The ClosureFast catheter is the only minimally invasive treatment with long-term results demonstrating its sustained success in treating patients with CVI."

The ClosureFast System is approved in approximately 90 markets across the globe including the United States, Europe, Brazil, Russia, Japan and India. This product is part of the Aortic and Peripheral Vascular business within Medtronic's Cardiac and Vascular Group.

Chronic Venous Insufficiency (CVI) is a progressive, sometimes debilitating medical condition. It occurs when valves in the veins of the lower leg no longer function to push blood back to the heart. This allows blood to flow backward, or reflux, resulting in enlarged, or varicose veins. If left untreated, the condition can progress and, in severe cases, can result in lifestyle-limiting lower leg pain, swelling, skin damage and ulcerations.ⁱⁱⁱ

In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular diseases and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.

About the ClosureFast™ catheter

The ClosureFast™ catheter is a minimally invasive treatment in which a vein specialist inserts the device that uses radiofrequency energy to collapse and close incompetent leg veins. After the vein is sealed shut, blood then re-routes to healthy veins. Compared with surgical options, the use of minimally invasive radiofrequency energy can result in less pain and quicker recovery time. [iv]