May 29, 2026Expert Review of Medical Devices0 citations
View Full PaperPolymer-free sirolimus-based submicron carrier-eluting stent: present and future perspective
Key Result
The polymer-free sirolimus-based submicron carrier-eluting stent with 73 μm struts showed complete drug elution by 40 days and no stent thrombosis at 12 months in preliminary clinical data.
Key Points
- This review aims to evaluate the design and early clinical performance of a novel polymer-free sirolimus-based submicron carrier-eluting stent.
- Summary of preclinical findings and early clinical experiences with the device.
- Discussion of ongoing randomized controlled trials, including the STARS DAPT pilot trial (NCT05785897).
- Analysis of drug release and endothelialization features of the hybrid stent.
- Demonstrated rapid endothelialization and minimal inflammation in preclinical studies.
- Early clinical data show low major adverse cardiovascular event rates (<1%) and no stent thrombosis at 12 months.
- The device provides biphasic sirolimus release over 40 days with prolonged drug exposure.
Structured PICO
P
Population
Patients undergoing percutaneous coronary intervention (including all-comers and ST-segment elevation myocardial infarction patients)
I
Intervention
Polymer-free sirolimus-based submicron carrier-eluting stent
This review highlights the potential of a novel polymer-free sirolimus-eluting stent with a hybrid design, showing promising early clinical safety and efficacy, though large-scale randomized data are still needed.
Limitations
- large-scale randomized evidence remains limited
Abstract
INTRODUCTION: .) 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, combining benefits of newer-generation DES and drug-coated balloon technologies, and representing the only contemporary DES integrating polymer-free stent and drug-coated balloon functionalities into a single platform. AREAS COVERED: This review summarizes the device concept, preclinical findings, early clinical experience, and ongoing randomized controlled trials evaluating the polymer-free sirolimus-based submicron carrier DES. EXPERT OPINION: 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.