Abstract 3833: Results From the Multi-Center Registry of the Novel AngioSculpt Scoring Balloon Catheter for the Treatment of Infra-Popliteal Disease
Background: The novel AngioSculpt (ASC) device incorporates a flexible nitinol scoring element containing 3 rectangular spiral struts which encircle a minimally compliant balloon to create focal concentration of the dilating force. The ASC was designed to treat complex diffuse fibro-calcific lesions and to avoid slippage/geographic miss during device deployment.
Methods: Pts scheduled for percutaneous intervention of infra-popliteal arteries or planned amputation and with a reference vessel diameter of 1.5–3.5 mm were included in the study.
Results: A total of 51 pts (age 73.8±9.2 yrs, males 62.8%) and 72 lesions were treated at 8 sites. Of these, 46 pts (90.2%) presented with critical limb ischemia (Rutherford Class ≥4). The ASC was successfully deployed in 95.8% (69/72) of lesions attempted and was used without adjunctive stenting in 87.5% (63/72) of lesions. Lesion morphology was complex, including moderate/severe calcification in 66.7%, lesion length 31.3±38.5 mm, bifurcation in 26.4% and ostial in 15.3%. There was no significant device slippage and no perforations. Post-ASC dissections occurred in only nine (12.5%) lesions and were minor or resolved with stenting. In 12 pts initially referred for amputation, treatment with the ASC resulted in limb salvage. Angiographic results are shown in the table⇓.
Conclusions: The AngioSculpt is highly effective in a broad range of complex lesion morphologies, in most cases as sole therapy, is associated with a very low complication rate and avoids device slippage during deployment. Follow-up studies are underway to assess the long term efficacy of this promising new technology.