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medi-dyne guiding catheter
Medi-Dyne
Summary: The medi-dyne guiding catheter is a device used primarily in venous stenting procedures. Key evidence highlights its efficacy in complex PCI scenarios and its role in reducing radial trauma.
FDA Clearance Information
Pathway
510K
Number
K970401 ↗
Decision Date
August 1, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The medi-dyne guiding catheter was cleared by the FDA via the 510(k) pathway on August 1, 1997. It is manufactured by Medi-Dyne and is classified as a Class 2 device.
What It Is
The medi-dyne guiding catheter is designed to facilitate the delivery of interventional devices during venous stenting procedures. It provides support and guidance for catheters and wires, particularly in complex anatomical situations.
Clinical Applications
This device is commonly used in percutaneous coronary interventions (PCI), especially in procedures involving chronic total occlusions and complex lesions. It is also utilized in transradial approaches to minimize trauma.
Evidence Summary
The available literature includes 10 studies, ranging from randomized controlled trials to expert panel reports, published between 2022 and 2024. These studies explore various aspects of guiding catheter use, including efficacy and safety.
Reported Outcomes
Published studies report that the medi-dyne guiding catheter is effective in facilitating complex PCI procedures, particularly in chronic total occlusions. The use of sheathless systems has been associated with reduced radial trauma and improved procedural success rates.
Safety Profile
Reported complications include the potential for catheter tip detachment and the need for retrieval techniques. However, overall safety profiles in the studies reviewed suggest a favorable risk-benefit ratio.
Evidence Limitations
The evidence base is limited by the small number of randomized controlled trials and a reliance on retrospective and case series data. Further research is needed to explore long-term outcomes and comparative effectiveness with other guiding systems.
Frequently Asked Questions
What are the clinical indications for medi-dyne guiding catheter?
The medi-dyne guiding catheter is indicated for use in venous stenting procedures, particularly in complex PCI and chronic total occlusions.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates and reduced radial trauma with the use of sheathless guiding systems in PCI.
What complications have been reported?
Safety data from evidence indicates potential complications such as catheter tip detachment, requiring retrieval techniques.
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.