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cypher sirolimus-eluting coronary stent system on the raptor otw delivery system or raptorrail rapid exchange delivery s
Cordis
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.
Clinical Applications
This device is commonly used in patients undergoing percutaneous coronary intervention (PCI) to treat coronary artery disease. It is particularly indicated for patients at high risk of restenosis.
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.
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.