Dedicated Bifurcation Drug-eluting Stent BiOSS® - A Novel Device for Coronary Bifurcation Treatment.

Abstract

The Bifurcation Optimisation Stent System (BiOSS®) (Balton®, Poland) is a coronary, dedicated bifurcation, balloon-expandable stent made of 316 litre stainless steel tube with strut thickness of 120 micrometre (µm). It is covered with a mixture of a biodegradable polymer and an antiproliferative substance - paclitaxel (BiOSS Expert version) or sirolimus (BiOSS Lim version). The stent consists of two parts (the proximal with a larger diameter in relation to the distal one) connected with two connection struts (average 1.2 mm in length) at the step-up middle zone. The stent is crimped on a bottle-shaped semi-complaint balloon (Bottle®, Balton, Poland). Our intravascular ultrasound (IVUS) study revealed that the construction of the BiOSS stent assures an easy access to the side branch and is comparable to the classic stent lumen enlargement with less injury to the area adjacent to the most sensitive part of the bifurcation. A total number of 65 lesions in 63 consecutive patients were enrolled in the First-In-Man (FIM) registry for BiOSS Expert, where we achieved a 100 % device success rate. The long-term clinical results were satisfactory and closely related to the high-risk profile of the treated population. Our data demonstrated that simple and fast bifurcation treatment with a single dedicated bifurcation paclitaxel-eluting stent (BiOSS Expert) is feasible and highly successful. Based on the data collected in animal experiments and preliminary data in humans with BiOSS Lim, releasing sirolimus from the surface of the biodegradable coating, one may presume that this version will provide even better clinical results compared with the paclitaxel one.