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catapult guide sheath
Contract Medical International
Summary: The Catapult Guide Sheath is a medical device used in embolization procedures, primarily by interventional radiologists and cardiologists. It aids in precise navigation and placement of embolization coils.
FDA Clearance Information
Pathway
510K
Number
K240957 ↗
Decision Date
August 14, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Catapult Guide Sheath received FDA clearance via the 510k pathway on August 14, 2024. Manufactured by Contract Medical International, it is classified as a Class 2 device.
What It Is
The Catapult Guide Sheath is a flexible, steerable sheath designed to facilitate the delivery and placement of embolization coils within the vascular system. It enhances the precision of coil deployment by providing a stable and navigable pathway for the coils to reach targeted sites within the vasculature. Its design allows for improved control and maneuverability during complex procedures.
Clinical Applications
This device is commonly used in interventional radiology and cardiology for procedures requiring embolization, such as treating aneurysms or arteriovenous malformations. It is particularly useful in settings where precise coil placement is critical, such as in cerebral or peripheral vascular interventions. The sheath is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The Catapult Guide Sheath is indicated for use in procedures requiring the delivery of embolization coils to occlude blood vessels. It is intended for patients who need vascular embolization to treat conditions like aneurysms or to control bleeding.
Practical Considerations
The sheath is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard embolization coils and is designed for use with imaging guidance to ensure accurate placement. Clinicians should be familiar with the handling and navigation techniques specific to steerable sheaths.
Related Literature
The linked study investigated the use of an intracardiac MR imaging guiding-sheath in swine models to enhance imaging during MR-guided electrophysiological interventions. The study found that the sheath provided improved signal-to-noise ratio and facilitated the navigation and monitoring of arrhythmia ablation procedures. However, the study's limitations include its preclinical nature and the need for further validation in human trials.
Frequently Asked Questions
What is the Catapult Guide Sheath used for?
It is used for delivering embolization coils to occlude blood vessels in procedures like treating aneurysms or controlling bleeding.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device during embolization procedures.
What are the FDA-cleared indications?
The device is indicated for use in delivering embolization coils to occlude blood vessels, particularly in treating aneurysms or arteriovenous malformations.
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.