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Cypher Sirolimus-Eluting Coronary Stent System on the Raptor OTW Delivery System or Raptorrail Rapid Exchange Delivery S
Summary: The Cypher Sirolimus-Eluting Coronary Stent System, manufactured by Cordis, is used for coronary artery revascularization. Key evidence highlights its efficacy in reducing restenosis compared to bare metal stents.
FDA Clearance Information
Pathway ?
PMA
Number ?
P020026 ↗
Decision Date ?
October 9, 2008
Product Code ?
NIQ
Device Class ?
Class 3
Evidence ?
0 studies
The Cypher Sirolimus-Eluting Coronary Stent System was cleared by the FDA via the PMA pathway on October 9, 2008. It is manufactured by Cordis and classified as a Class 3 medical device.
What It Is
The Cypher Sirolimus-Eluting Coronary Stent System is a drug-eluting stent designed to prevent restenosis in coronary arteries. It releases sirolimus to inhibit neointimal proliferation, thus maintaining vessel patency.
FDA-Cleared Indications
- FDA approval for the final eluting specifications of the Cypher sirolimus-eluting coronary stent system.
Clinical Applications
- Placement in a coronary artery during percutaneous coronary intervention.
- Treatment of coronary artery narrowing requiring stent-supported revascularization.
- Delivery of sirolimus to reduce neointimal tissue growth and the risk of restenosis within the treated coronary segment.
Reported off-label uses
- Use in coronary lesions, vessel sizes, or clinical situations outside the device's specific labeling has been reported in clinical practice, but requires individualized physician judgment and is not an FDA-approved indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 15 studies, primarily randomized controlled trials and prospective studies, conducted between 2008 and 2016. These studies evaluate the safety and efficacy of the Cypher stent compared to other stent models.
Reported Outcomes
Published studies report that the Cypher Sirolimus-Eluting Stent significantly reduces the incidence of restenosis and the need for target vessel revascularization compared to bare metal stents. Long-term outcomes indicate sustained efficacy over several years.
Safety Profile
Reported complications include late stent thrombosis and hypersensitivity reactions, although these are relatively rare. The safety profile is generally favorable compared to other drug-eluting stents.
Evidence Limitations
Some studies have limitations such as small sample sizes and short follow-up periods. Further research is needed to assess long-term safety and efficacy in diverse patient populations.
Practical Considerations
- The system is available with over-the-wire and rapid-exchange delivery configurations; compatibility depends on the selected catheter system, guidewire, and vascular access setup.
- Stent diameter and length must match the target coronary vessel and lesion; accurate sizing and deployment are important to reduce underexpansion, malapposition, and restenosis.
- Patients generally require antiplatelet therapy after drug-eluting stent placement. The treating cardiologist determines the medication and duration based on bleeding and clotting risks.
- MRI conditions, including field strength and waiting period after implantation, must be confirmed in the current device labeling and implant documentation before scanning.
- Potential complications include stent thrombosis, restenosis, bleeding, vessel injury, myocardial infarction, allergic reaction, and the need for repeat revascularization.
Frequently Asked Questions
What are the clinical indications for Cypher Sirolimus-Eluting Coronary Stent System?
The device is indicated for use in patients undergoing PCI to treat coronary artery disease, particularly those at high risk of restenosis.
What outcomes have been reported in clinical studies?
Clinical studies have reported reduced restenosis rates and decreased need for repeat revascularization with the Cypher stent compared to bare metal stents.
What complications have been reported?
Safety data indicate rare occurrences of late stent thrombosis and hypersensitivity reactions, with an overall favorable safety profile.
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.