đź“Š Evidence-Based Reference
Orsiro Mission Sirolimus Eluting Coronary Stent System
Summary: The Orsiro Mission Sirolimus Eluting Coronary Stent System by Biotronik is a coronary stent designed for treating coronary artery lesions. Key evidence highlights its effectiveness in maintaining stent patency and strut coverage, with moderate allergic reactions reported in patients with metal allergies.
FDA Clearance Information
Pathway ?
PMA
Number ?
P170030 ↗
Decision Date ?
December 21, 2023
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Orsiro Mission Sirolimus Eluting Coronary Stent System received FDA PMA clearance on December 21, 2023. Manufactured by Biotronik, it is classified as a Class 3 device.
What It Is
The Orsiro Mission is a sirolimus-eluting coronary stent system designed to treat coronary artery lesions by releasing sirolimus to inhibit restenosis. It is intended for use in patients requiring coronary artery stenting.
FDA-Cleared Indications
- FDA PMA P170030 includes an update to the maximum post-dilatation diameter specification for the T6S stent design, increasing it from 3.5 mm to 4.0 mm.
- The device is indicated for coronary artery stenting according to its approved labeling.
Clinical Applications
- Percutaneous coronary intervention involving placement of a drug-eluting stent in a coronary artery
- Treatment of coronary artery lesions requiring mechanical vessel support after balloon angioplasty
- Release of sirolimus at the treated coronary lesion to help reduce neointimal growth and restenosis
- Post-dilatation of the T6S stent design up to the FDA-approved maximum diameter of 4.0 mm
Evidence Summary
The available literature includes five studies, comprising case reports and clinical trials, focusing on the safety and effectiveness of the Orsiro Mission stent. These studies span from 2025 and include both published and ongoing research.
Reported Outcomes
Published studies report good stent patency and high strut coverage percentages, with no thrombus formation observed in the short term. Long-term follow-up indicates sustained strut coverage and absence of peri-stent contrast staining, suggesting effective performance in maintaining vessel patency.
Safety Profile
Reported complications include moderate allergic reactions to nickel and cobalt-chromium in patients with metal allergies. No thrombus formation was noted, indicating a favorable safety profile in terms of thrombogenicity.
Evidence Limitations
The evidence is limited by the small sample size and the specific focus on patients with metal allergies, which may not be generalizable to the broader population. Further research is needed to assess long-term outcomes and safety in diverse patient groups.
Practical Considerations
- The stent is delivered through a catheter, commonly using femoral or radial arterial access, with fluoroscopic imaging guidance.
- The T6S stent design has an FDA-approved maximum post-dilatation diameter of 4.0 mm under the updated specification.
- Patients generally require antiplatelet therapy after placement; the treating cardiologist determines the medication regimen and duration.
- MRI conditions should be confirmed in the current device labeling before scanning. Patients should tell MRI staff that they have a coronary stent.
- Coronary stenting may not be appropriate in patients who cannot receive required antiplatelet therapy or who have a relevant allergy or contraindication to device materials or medications.
Frequently Asked Questions
What are the clinical indications for Orsiro Mission Sirolimus Eluting Coronary Stent?
The device is indicated for treating coronary artery lesions, with an updated specification allowing a maximum post-dilatation diameter of 4.0 mm.
What outcomes have been reported in clinical studies?
Studies report good stent patency, high strut coverage, and no thrombus formation, indicating effective performance in maintaining vessel patency.
What complications have been reported?
Safety data indicate moderate allergic reactions to nickel and cobalt-chromium in patients with metal allergies, with no thrombus formation observed.
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.