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Study shows ClosureFAST catheter is more than 96 percent effective at sealing veins

VNUS Medical Technologies : 25 February, 2008  (New Product)
VNUS Medical Technologies has presented positive clinical performance data for the VNUS ClosureFAST catheter at the 20th annual meeting of the American Venous Forum in Charleston, South Carolina, USA.
An international panel of physicians presented clinical trial results and perspectives affirming the efficacy and patient comfort levels of endovenous radiofrequency (RF) vein ablation using VNUS ClosureFAST. The ClosureFAST catheter, in a procedure often performed in the physician's office, heats and seals the diseased leg veins that cause the varicose veins afflicting more than 25 million Americans.

Prof Dr Thomas M Proebstle of Heidelberg, Germany presented one-year follow-up data from a prospective, multi-centre study of the efficacy of the ClosureFAST catheter. Raymond G Makhoul, MD, of Richmond, Virginia, USA, presented results from the RECOVERY trial, a single-blinded, randomised trial comparing the ClosureFAST Catheter with endovenous laser ablation in 62 limbs.

'Our study found the ratio of efficacy to side effects of the VNUS ClosureFAST Catheter to be superior to any previous endovenous ablation device,' said Dr Proebstle. 'In 223 cases where the ClosureFAST device was used, 96.7 percent of the veins remained sealed after one year using Kaplan-Meier analysis. Of my patients, only one in five experienced postoperative pain due to study treatment. The excellent clinical outcome, the speed of treatment and the very low rate of side effects are certainly contributing to the enthusiastic embrace of this new device by the physician community.'

'Our RECOVERY trial data makes it clear that radiofrequency vein ablation with the ClosureFAST device is superior to laser ablation in terms of patient comfort and satisfaction,' said Dr Makhoul. '27 percent of the ClosureFAST patients reported that the procedure itself was completely pain-free, compared with just three percent of the laser patients, and the need for postoperative analgesics was lower with ClosureFAST patients than with laser patients. We believe that the increased patient satisfaction with ClosureFAST is serving as a strong incentive for vascular physicians to transition to the ClosureFAST Catheter from previous devices.'

'The ClosureFAST device has significantly improved endothermal ablation with a smooth, deliberate, controlled and much swifter technique,' said Robert F Merchant, MD, of Reno, Nevada, USA, who has been performing RF vein ablation since 1999. 'With some simple but elegant modifications to the technique - proper positioning of the Catheter away from the deep vein system, elevation of the leg - we've been able to produce an even lower rate of complications and make the procedure even easier for the physician.'

'Endovenous ablation of the great saphenous vein has revolutionised the way that we care for the venous patient,' said Thomas F O'Donnell Jr, MD, of Boston, Massachusetts, USA, who moderated the physicians' panel. 'In our own practice I have seen confirmation of the results from Dr Proebstle's multi-centre ClosureFAST trial that this newer generation Catheter is faster and easier to use. And the evidence-based results from the randomised, prospectively controlled trial by Dr Makhoul and his colleagues confirms anecdotal experience that the RF Catheter appears to be kinder and gentler without sacrificing effective durable closure rates.'

'We believe the findings presented by the physicians paint a compelling picture of the VNUS ClosureFAST Catheter as the new treatment of choice for patients who suffer from the pain, swelling and discomfort of varicose veins,' said Brian E Farley, president and chief executive officer of VNUS. 'The documented efficacy of the device and the overwhelmingly positive responses of physicians and patients regarding its ease of use, comfort and mild recovery are driving the rapid adoption of the ClosureFAST catheter, resulting in substantial benefits to varicose vein patients in over 40 countries.'
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