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|British Journal of Surgery Publishes Five-Year ClosureFast(TM) Study Results|
Results Demonstrate Durability, Effectiveness of Treatment for Chronic Venous Insufficiency
DUBLIN - Feb. 10, 2015 - The ClosureFast(TM) endovenous radiofrequency ablation catheter from Medtronic plc (NYSE: MDT) 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.
"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,2 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.3
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.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Almeida, J., Kaufman, J., Göckeritz, O., et al. Radiofrequency endovenous ClosureFast versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY Study). J Vasc Interv Radiol. 2009;20:752-759.
2 Proebstle, TM., et al. Three-year European follow-up of endovenous radiofrequency-powered segmental thermal ablation of the great saphenous vein with or without treatment of calf varicosities. J Vasc Surg. 2011 Jul;54(1):146-52. doi: 10.1016/j.jvs.2010.12.051.
3 L. H. Rasmussen, M. Lawaetz, L. Bjoern, B. Vennits, A. Blemings, and B. Eklof, Randomized Clinical Trial Comparing Endovenous Laser Ablation, Radiofrequency Ablation, Foam Sclerotherapy and Surgical Stripping for Great Saphenous Varicose Veins. British Journal of Surgery Society. www.bjs.co.uk, March 15, 2011.