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| Covidien Announces Five-Year Results from the ClosureFast™ Long-Term European Multi-Center Study in Patients with Lower Limb Venous Disease |
Study Demonstrates Long-Term Durability of the ClosureFast™ Radiofrequency Ablation System for Treatment of Chronic Venous Insufficiency
The ClosureFast Study was conducted prospectively at eight centers in
"The five-year final analysis from the ClosureFast Study shows sustained
treatment success in anatomical and clinical categories and supports its
leading position in endovenous vein treatment," said ClosureFast Study Design and Five-Year Results
This prospective, multi-center study enrolled 225 patients and treated
295 limbs at eight centers in Patients were evaluated following the procedure by duplex ultrasound imaging and clinical examination at three days, three months, six months and in yearly intervals up to five years. Of the 295 treated limbs, 233 (79%) were available for examination at five years. According to Kaplan-Meier analysis, at five-year follow-up, full occlusion of the treated vein was observed in 92% of patients (vs. 98% at one year). The vast majority (95%) of patients were free of pathological venous reflux (vs. 99% at one year). This demonstrates durable results of the Venefit™ procedure out to five years. The average Venous Clinical Severity Score (a multifactorial score measuring disease severity and quality of life) improved from 3.9 ± 2.1 before treatment to 1.3 ± 1.7 at 5 years. In addition, only 14% of limbs were CEAP (disease severity classification) class 3 or higher at 5 years, while, at baseline, 48% of limbs were in the same category.
“This pivotal study provides substantial long-term data on relevant
end-points to help clinicians decide the appropriate treatment for their
patients, thus defining Covidien’s commitment to a strong foundation of
clinical research,” said About CVI and the Venefit Procedure CVI, or Chronic Venous Insufficiency, 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, skin damage and ulcerations. Traditional surgical treatments that close or remove the diseased veins, including vein stripping, may be painful and can result in long recovery times for patients.ii Alternatively, patients can be treated with a minimally invasive endovascular procedure such as the Venefit procedure. During the Venefit procedure, the ClosureFast catheter is inserted into the diseased vein and radiofrequency energy is used to seal the vein shut. Blood that would normally return to the heart through the diseased vein travels back through other veins instead. Over time, the treated vein shrinks and is absorbed by the body. Compared with surgical options, minimally invasive ablation of the vein can result in less pain and quicker recovery time.ii
About
1 Gloviczki P, et al. The care of patients with varicose
veins and associated chronic diseases: clinical practice guidelines of
the Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20121220005282/en/ Source:
Vascular Therapies |