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Slender Sirolimus-Eluting Coronary Stent Integrated Delivery System and Direct Sirolimus-Eluting Coronary Stent Rapid Ex
Advanced Bifurcation Systems
Summary: The Slender Sirolimus-Eluting Coronary Stent is designed to improve coronary artery luminal diameter in patients with symptomatic heart disease. It is FDA-cleared and supported by two studies, highlighting its innovative delivery system.
FDA Clearance Information
Pathway ?
PMA
Number ?
P210014 ↗
Decision Date ?
December 13, 2021
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Slender Sirolimus-Eluting Coronary Stent, manufactured by Advanced Bifurcation Systems, received FDA PMA clearance on December 13, 2021. It is classified as a Class 3 device.
What It Is
The device is a sirolimus-eluting coronary stent integrated with a delivery system, intended to improve coronary artery luminal diameter. It is used in patients with symptomatic heart disease due to atherosclerotic lesions.
FDA-Cleared Indications
- The Slender Sirolimus-Eluting Coronary Stent Integrated Delivery System is indicated for improving coronary artery luminal diameter in symptomatic patients with atherosclerotic lesions up to 24 mm long in native coronary arteries measuring 2.25 to 4.00 mm in reference diameter.
- The Direct Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System is indicated for improving coronary artery luminal diameter in symptomatic patients with atherosclerotic lesions up to 34 mm long in native coronary arteries measuring 2.25 to 4.00 mm in reference diameter.
- Both systems may be used with direct stenting or after pre-dilatation using percutaneous coronary intervention techniques.
Clinical Applications
- Percutaneous coronary intervention for symptomatic coronary artery disease caused by atherosclerotic narrowing.
- Stenting short native-coronary lesions up to 24 mm with the Slender system.
- Stenting native-coronary lesions up to 34 mm with the Direct rapid-exchange system.
- Treatment of native coronary arteries with reference vessel diameters from 2.25 to 4.00 mm.
- Direct stenting or stenting after balloon pre-dilatation, as specified in the labeling.
Evidence Summary
The available literature includes two studies: one published in 2018 and another with an unknown date. These studies encompass various methodologies, including RCTs and prospective designs.
Reported Outcomes
Published studies report that the Slender Sirolimus-Eluting Coronary Stent effectively improves coronary artery luminal diameter. The device's integrated delivery system facilitates direct stenting, potentially reducing procedure time and complexity.
Safety Profile
Reported complications include typical risks associated with coronary stenting, such as restenosis and thrombosis. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence is limited by the small number of studies and lack of comprehensive safety data. Further research is needed to establish long-term outcomes and broader safety profiles.
Practical Considerations
- The labeled lesion and vessel-size ranges differ by system: up to 24 mm for the Slender system and up to 34 mm for the Direct system, with reference vessel diameters of 2.25 to 4.00 mm.
- The stent is delivered through a coronary catheter system under fluoroscopic imaging during percutaneous coronary intervention.
- Patients generally require antiplatelet therapy after drug-eluting stent placement; the treating cardiologist determines the regimen and duration.
- MRI eligibility, field-strength conditions, waiting requirements and other scanning parameters should be confirmed in the current device labeling and implant documentation.
- Use is subject to the device's full labeling, including contraindications, warnings, precautions, access-system compatibility and restrictions on lesion or vessel anatomy.
Frequently Asked Questions
What are the clinical indications for Slender Sirolimus-Eluting Coronary Stent?
The device is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to atherosclerotic lesions up to 24 mm in length in native coronary arteries with specific vessel diameters.
What outcomes have been reported in clinical studies?
Studies report effective improvement in coronary artery luminal diameter and the facilitation of direct stenting, potentially reducing procedure time.
What complications have been reported?
Reported complications include restenosis and thrombosis, common risks associated with coronary stenting.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.