📋 FDA Reference
Catapult Guide Sheath
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 ?
510(k)
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.
FDA-Cleared Indications
- Used to facilitate the delivery of embolization coils through the vascular system.
- Used to support placement of embolization coils for occlusion of targeted blood vessels.
- Intended for image-guided endovascular procedures in which controlled coil delivery and positioning are required.
Clinical Applications
- Delivery and placement of embolization coils during treatment of selected aneurysms or pseudoaneurysms.
- Coil embolization to control bleeding from a targeted blood vessel.
- Endovascular occlusion of selected abnormal vascular channels when coil embolization is indicated.
- Navigation and coil delivery during peripheral or visceral vascular embolization procedures.
Practical Considerations
- The appropriate sheath size, length and configuration depend on the access site, vessel diameter, target anatomy and embolization system being used.
- The device is navigated under fluoroscopy or other appropriate imaging guidance by clinicians trained in endovascular procedures.
- Compatibility with the selected embolization coils, guidewires, catheters and other equipment should be confirmed before use.
- The FDA record provided does not establish that the sheath is MRI safe or MRI conditional; consult the current manufacturer labeling before exposing the device to an MRI environment.
- Contraindications, warnings and preparation requirements should be reviewed in the current instructions for use. General risks include bleeding, infection, vessel injury, thrombosis, embolization to an unintended vessel and complications related to contrast or radiation.
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.
Procedures that use this device
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.