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synergy xd everolimus-eluting platinum chromium coronary stent system synergy xd everolimus-eluting platinum chromium c
Boston Scientific
Summary: The Synergy XD Everolimus-Eluting Stent is a coronary stent system used to treat coronary artery disease. It is primarily used by interventional cardiologists to improve blood flow in patients with narrowed or blocked coronary arteries.
FDA Clearance Information
Pathway
PMA
Number
P150003 ↗
Decision Date
November 30, 2020
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Synergy XD Everolimus-Eluting Stent, manufactured by Boston Scientific, received FDA clearance through the PMA pathway on November 30, 2020. It is classified as a Class 3 medical device.
What It Is
The Synergy XD Everolimus-Eluting Stent is a drug-eluting stent made from platinum chromium, designed to release everolimus to prevent restenosis in coronary arteries. The stent's design allows for flexibility and conformability to the vessel wall, providing support while minimizing the risk of vessel re-narrowing. The everolimus coating helps reduce the risk of restenosis by inhibiting cell proliferation at the stent site.
Clinical Applications
This stent is commonly used in interventional cardiology procedures to treat patients with coronary artery disease, particularly those with significant stenosis or blockages. It is typically deployed in catheterization labs during percutaneous coronary interventions (PCI). The device is suitable for a wide range of patients, including those with complex lesions or a history of restenosis, and is often used in both elective and emergency settings.
Indications for Use
The FDA indications suggest the stent is used to improve blood flow in patients with coronary artery disease by keeping the arteries open after angioplasty. It is particularly beneficial for patients who require a reduction in restenosis risk due to its drug-eluting properties.
Practical Considerations
The Synergy XD Stent is available in various sizes to accommodate different vessel diameters and lesion lengths. It is compatible with standard delivery systems used in PCI procedures. Clinicians should consider vessel size and lesion characteristics when selecting the appropriate stent size and ensure proper deployment technique to optimize outcomes.
Frequently Asked Questions
What is the Synergy XD Everolimus-Eluting Stent used for?
It is used to treat coronary artery disease by keeping arteries open and reducing the risk of restenosis.
What specialties typically use this device?
Interventional cardiologists primarily use this device during percutaneous coronary interventions.
What are the FDA-cleared indications?
The stent is indicated for improving blood flow in coronary arteries and reducing restenosis risk in patients with coronary artery disease.
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.