Device used to optimize stenting of complex lesions

The AngioSculpt (ASC) device is designed to optimize stenting of difficult-to-treat lesions and to avoid slippage or "geographic miss." It incorporates a flexible nitinol scoring element consisting of 3 rectangular spiral struts which encircle an angioplasty balloon thereby allowing more effective plaque modification particularly of fibro-calcific lesions.

In this study, 521 patients with complex blockages in their coronary arteries were treated with percutaneous coronary intervention (PCI). Using intravascular ultrasound (IVUS) guidance in most of these patients, the ASC was used for pre-dilation and plaque-modification to optimize stent implantation (predominantly drug-eluting stents). It resulted in a high procedural success rate and excellent long-term outcomes (up to 3 years). Results included a very low rate of heart-related complications, dangerous blood clots called stent thrombosis that can form in the stent, and repeat procedures due to lesion revascularization in patients with complex disease (such as significant calcification, diffuse disease or at a bifurcation) and a high rate of diabetes.

Dr. Grenadier said that, "ASC slippage was very rare (1.2%), thereby avoiding 'geographic miss,' and the rate of significant dissections post-ASC was rare (1.5%) and much lower than the historic rate with conventional balloons (POBA) for pre-dilation. There were no perforations despite the highly complex lesions treated.-Cardiovascular Research Foundation