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ion taxus element paclitaxel-eluting coronary stent system
Boston Scientific
Summary: The Ion Taxus Element is a paclitaxel-eluting coronary stent system used primarily for coronary artery disease. Key evidence highlights its efficacy in reducing major adverse cardiac events compared to other stents.
FDA Clearance Information
Pathway
PMA
Number
P100023 ↗
Decision Date
July 26, 2012
Product Code
NIQ
Device Class
Class 3
Evidence
0 studies
The Ion Taxus Element Paclitaxel-Eluting Coronary Stent System was cleared by the FDA via the PMA pathway on July 26, 2012. It is manufactured by Boston Scientific and classified as a Class 3 device.
What It Is
The Ion Taxus Element is a coronary stent system that elutes paclitaxel, a drug that inhibits cell proliferation. It is designed for use in patients with coronary artery disease to prevent restenosis after angioplasty.
Clinical Applications
This device is commonly used in interventional cardiology for patients undergoing percutaneous coronary interventions, particularly in those at risk of restenosis. It is suitable for both routine and complex coronary lesions.
Evidence Summary
The available literature includes four studies, comprising randomized controlled trials and retrospective analyses, conducted between 2005 and 2020. These studies evaluate the clinical outcomes and safety of the Ion stent in diverse patient populations.
Reported Outcomes
Published studies report that the Ion stent is associated with a lower incidence of major adverse cardiac events compared to the TAXUS Liberté stent, with an 8.3% event rate versus 12.7%. Additionally, the incidence of non-Q-wave myocardial infarction was lower in the Ion group at 1.4% compared to 2.9% in the comparator group.
Safety Profile
Reported complications include a risk of restenosis and myocardial infarction, although these are reduced compared to older stent models. The studies did not highlight any new safety concerns specific to the Ion stent.
Evidence Limitations
The evidence is limited by the heterogeneity of study designs and patient populations. Further research is needed to assess long-term outcomes and to compare the Ion stent with newer generation drug-eluting stents.
Frequently Asked Questions
What are the clinical indications for Ion Taxus Element Paclitaxel-Eluting Coronary Stent System?
The device is indicated for use in patients with coronary artery disease to prevent restenosis following angioplasty.
What outcomes have been reported in clinical studies?
Studies report a reduction in major adverse cardiac events and non-Q-wave myocardial infarctions compared to older stents.
What complications have been reported?
Safety data indicate risks of restenosis and myocardial infarction, though these are lower compared to previous stent models.
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.