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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
510K
Number
K970823 ↗
Decision Date
June 3, 1997
Product Code
DQY
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.
Clinical Applications
Commonly used in percutaneous transluminal coronary angioplasty (PTCA) and stent implantation procedures, this catheter is suitable for cases requiring precise guidance and support in vascular interventions.
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.
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.