Polymer-free sirolimus-based submicron carrier-eluting stent: present and future perspective

Newer-generation drug-eluting stents (DES) remain associated with late adverse events, necessitating continued innovation. The Focus np (Abluminus np, Concept Medical, Tampa, FL, USA) is a novel thin-strut cobalt-chromium sirolimus-eluting stent featuring a polymer-free metallic platform with abluminal phospholipid submicron carrier coating and fusion coating extending drug delivery to stent shoulders and exposed balloon surfaces, representing the only contemporary DES integrating polymer-free stent and drug-coated balloon functionalities into a single platform..

This review summarizes the device concept, preclinical findings, early clinical experience, and ongoing randomized controlled trials evaluating the device.

This device introduces a hybrid design featuring 73 μm struts with abluminal phospholipid coating providing biphasic sirolimus release over 40 days with prolonged in-tissue exposure, alongside fusion coating covering platform, gaps, and edge zones. Preclinical studies demonstrate rapid endothelialization, minimal inflammation, and complete drug elution by 40 days. Preliminary clinical data in all-comers show low major adverse cardiovascular event rates without stent thrombosis at 12 months. The STARS DAPT pilot trial (NCT05785897) is evaluating single antiplatelet therapy following abbreviated dual antiplatelet therapy versus conventional regimens in ST-segment elevation myocardial infarction patients undergoing primary percutaneous coronary intervention with this device. However, large-scale randomized evidence remains limited.