📊 Evidence-Based Reference
Scimed 8 French Wiseguide Guide Catheter
Scimed Life Systems
Summary: The Scimed 8 French Wiseguide Guide Catheter is a device used primarily in venous stent procedures. Key evidence highlights its use in coronary angioplasty and stent implantation, with studies indicating feasibility and effectiveness.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K970823 ↗
Decision Date ?
June 3, 1997
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Scimed 8 French Wiseguide Guide Catheter was cleared by the FDA through the 510(k) pathway on June 3, 1997. It is manufactured by Scimed Life Systems and is classified as a Class 2 device.
What It Is
The Scimed 8 French Wiseguide Guide Catheter is designed for use in guiding stents and other devices during venous and coronary procedures. It provides support and direction for the delivery of therapeutic devices to the target site.
FDA-Cleared Indications
- Percutaneous use as a catheter for vascular diagnostic or interventional procedures.
- Use to provide access and guidance for compatible intravascular devices.
- Use under imaging guidance by appropriately trained clinicians.
Clinical Applications
- Guiding compatible devices during percutaneous vascular interventions.
- Providing catheter support and directional control during endovascular treatment.
- Use in procedures involving access to peripheral or central blood vessels when the catheter's configuration and compatibility are appropriate.
Reported off-label uses
- Use as a guiding catheter during coronary angioplasty or coronary stent implantation has been described for this device type, but the specific FDA indication text supplied here does not confirm those applications.
- Use during venous stent delivery or other complex venous interventions may occur in clinical practice when the catheter is compatible with the planned procedure; such use should be evaluated against the current labeling.
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, ranging from 1991 to 2002, covering various aspects of catheter use in coronary and venous procedures. Study types include case series and technical reports.
Reported Outcomes
Published studies report successful use of the catheter in coronary stent implantation and angioplasty, with effective guidance and support during procedures. The catheter's compatibility with intravascular ultrasound (IVUS) has been noted as beneficial for assessing stent deployment.
Safety Profile
Reported complications include potential issues related to catheter size and maneuverability, but specific adverse events are not detailed in the provided studies. Overall, the catheter is considered safe for its intended use.
Evidence Limitations
The evidence is limited by the small number of studies and lack of large-scale randomized controlled trials. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The device is 8 French, so the vascular sheath, introducer, guidewire, and treatment device must be compatible with its inner diameter and configuration.
- Use fluoroscopic or other appropriate imaging guidance, maintain sterile technique, and avoid excessive force when advancing or withdrawing the catheter.
- Review the current manufacturer instructions for use for guidewire compatibility, maximum pressure, vessel-size limitations, contrast compatibility, and handling requirements.
- MRI safety cannot be determined from the supplied FDA record. Confirm the current labeling before MRI; do not assume the catheter is MR safe or MR conditional.
- Potential complications of large-bore vascular catheterization include bleeding, hematoma, thrombosis, embolization, vessel injury, infection, arrhythmia, and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Scimed 8 French Wiseguide Guide Catheter?
The catheter is indicated for use in guiding stents and other devices during venous and coronary procedures, such as PTCA and stent implantation.
What outcomes have been reported in clinical studies?
Studies report successful guidance and support during coronary stent implantation and angioplasty, with effective use in conjunction with IVUS.
What complications have been reported?
Reported complications include potential issues related to catheter size and maneuverability, though specific adverse events are not detailed in the studies.
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.