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Synergy Xd Everolimus-Eluting Platinum Chromium Coronary Stent System Synergy Xd Everolimus-Eluting Platinum Chromium C
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.
FDA-Cleared Indications
- The FDA record for PMA P150003 documents removal of confirmatory testing requirements for several solvents.
- The device is labeled as a coronary stent system for use in percutaneous coronary intervention according to its approved labeling.
Clinical Applications
- Treatment of coronary artery stenosis during angioplasty and stent placement.
- Support of a coronary artery after balloon angioplasty or lesion preparation.
- Drug-eluting stent treatment intended to reduce restenosis compared with an unstented or bare-metal-treated segment.
- Use in elective or urgent coronary interventions when the treating interventional cardiologist determines that a coronary stent is appropriate.
Practical Considerations
- The stent is made from platinum chromium and delivers everolimus from a drug-polymer coating.
- The correct stent diameter and length must be selected for the target vessel and lesion; available sizes depend on the specific product configuration.
- It is delivered through a catheter during coronary angiography, typically through radial or femoral arterial access, with imaging guidance and usually local anesthesia with moderate sedation.
- Patients require assessment for dual antiplatelet therapy and other medication needs after implantation; inability to take recommended antiplatelet treatment is an important clinical concern.
- MRI conditions, including field strength and waiting requirements, must be confirmed in the current manufacturer instructions for use. The device should not be considered universally MRI safe without checking its MR labeling.
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.