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Ion Taxus Element Paclitaxel-Eluting Coronary Stent System
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.
FDA-Cleared Indications
- Software modification to the balloon-stretching process.
Clinical Applications
- Deployment in a coronary artery during percutaneous coronary intervention when use is consistent with the device's approved labeling.
- Treatment of a coronary artery lesion after balloon angioplasty with placement of a drug-eluting stent.
- Local delivery of paclitaxel from the stent to help reduce neointimal tissue growth and restenosis.
Reported off-label uses
- Use in coronary lesions, vessel sizes, or clinical situations outside the specific anatomical and patient criteria in the approved labeling may occur in practice, but should be considered off-label and evaluated by the treating cardiologist.
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 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.
Practical Considerations
- The device is delivered through a coronary catheter and expanded with a balloon under fluoroscopic imaging; the labeled stent diameter and length must match the target vessel and lesion.
- Patients require appropriate antiplatelet therapy after drug-eluting stent placement unless contraindicated; the treating cardiologist determines the regimen and duration.
- Contraindications and warnings include factors such as inability to receive required antiplatelet or anticoagulant therapy, significant bleeding risk, or allergy to device materials or paclitaxel.
- MRI conditions depend on the specific approved labeling, implanted stent configuration, field strength, and scanning conditions; the current device instructions should be checked before MRI.
- This is a coronary device and is not intended for the listed DVT, pulmonary embolism, or dialysis-access thrombectomy procedures.
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.