Professor Thomas Proebstle, University of Heidelberg, Germany, has presented the first report of six-month follow-up clinical results from a multi-centre clinical trial of the new ClosureFAST endovenous radiofrequency (RF) vein ablation catheter at the American Venous Forum meeting in San Diego, CA, and CX.
The VNUS ClosureFAST catheter is designed to heat, shrink and occlude refluxing saphenous veins with RF ablation times of just three to five minutes while maintaining the fast and mild patient recovery that physicians expect with RF vein ablation. Like the original VNUS Closure catheter, the new ClosureFAST catheter monitors treatment temperature and controls energy delivery. It is designed to avoid the vein perforations and related post-procedure pain and bruising that are commonly associated with endovenous laser treatment.
Proebstle reported on 252 limbs in 194 patients with saphenous vein reflux who were treated with the VNUS ClosureFAST RF catheter. The patients were treated at eight centres in Germany and France from April through November 2006. One hundred sixty four limbs had three months follow-up data and 62 limbs had six months follow-up data. Vein occlusion rate was 100% at three and six months. The largest veins treated were 18mm in diameter. No serious complications such as deep venous thrombosis or thermal skin injury were observed in any patients in the study.
“ClosureFAST provides the ability to deliver high-energy dosage to obtain a successful treatment but almost totally without the disturbing side effects of laser. After my first 100 cases I find these initial results very encouraging and look forward to expanding my use of this product,” said Proebstle.
Treatments with the ClosureFAST catheter resulted in an average energy delivery time of 2.2 minutes and the average procedure time (measured from catheter insertion to catheter removal, including the time for the administration of tumescent anaesthesia) was 16.4 minutes.
“Feedback from physicians has been extremely positive on the performance, the speed, and the ease of use of the catheter,” stated the company’s Medical Director and vice president of Clinical Research, Dr Lian X Cunningham. “In addition, ClosureFAST catheter investigators reported that the patient recovery profile has been rapid and mild as expected with RF ablation.”
The ClosureFAST RF catheter received 510(k) clearance from the FDA in the US in August 2006.