A New Approach to Plaque Removal: The Redha-Cut Device.

PURPOSE: To prospectively determine the safety, feasibility and efficacy of a new atherectomy device. Methods. Seventy patients with 93 symptomatic femoro-popliteal lesions underwent percutaneous atherectomy with Redha-cut, a metallic, flexible catheter. The device works on pull-back with two umbrella-like blades and enables cutting, retaining and removing of material. Quantitative analysis of the angiograms was performed. RESULTS: Obtaining of atherectomized samples was successful in all cases. The mean atherectomy time was 5 +/- 2 minutes. The stenoses were reduced from 74 +/- 2.3% before to 26 +/- 2% after atherectomy (p < 0.001). Subsequent PTA, which was performed to optimize the results, further decreased the degree of stenosis to 17% (p > 0.5). No perforations, acute closure or early re-thrombosis occurred. Cumulative patency rates according to the findings of non-invasiveive examinations were 83% at 6 months and 66% at 12 months. Conclusions. The Redha-cut device is a simple, safe and efficacious tool for biopsy sampling and atherectomy. Further studies randomizing patients either to balloon or atherectomy are planned to compare this technique with others in regard to long-term patency.