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low profile companion sheath
Merit Medical Systems
Summary: The Low Profile Companion Sheath is a medical device used in embolization procedures, primarily by interventional radiologists and vascular surgeons. It facilitates the delivery of embolization coils to treat vascular abnormalities.
FDA Clearance Information
Pathway
510K
Number
K223872 ↗
Decision Date
January 19, 2023
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Low Profile Companion Sheath was cleared through the FDA 510(k) pathway on January 19, 2023. Manufactured by Merit Medical Systems, it is classified as a Class 2 device under product code DYB.
What It Is
The Low Profile Companion Sheath is a specialized catheter designed to assist in the delivery of embolization coils during minimally invasive procedures. It features a low-profile design that allows for easier navigation through the vascular system, minimizing trauma to the vessel walls. This device is particularly useful in procedures requiring precise placement of embolic materials to occlude blood vessels.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for embolization procedures. It is particularly useful in treating conditions such as arteriovenous malformations, aneurysms, and other vascular abnormalities. The sheath's design allows it to be used in a variety of patient populations, including those with challenging vascular anatomy.
Indications for Use
The Low Profile Companion Sheath is indicated for use in procedures requiring the delivery of embolization coils. It is suitable for patients with conditions that necessitate the occlusion of blood vessels, such as aneurysms or arteriovenous malformations.
Practical Considerations
The sheath is available in various sizes to accommodate different vessel diameters and is compatible with standard embolization coils. Clinicians should consider the patient's vascular anatomy and the specific requirements of the procedure when selecting the appropriate sheath size.
Related Literature
The linked study examined the adverse events associated with the PrePex device for non-surgical male circumcision in Uganda. It highlighted the importance of device-based approaches in achieving public health targets for HIV prevention. While the study focused on a different device, it underscores the role of minimally invasive devices in improving procedural outcomes. Limitations include its focus on a specific population and procedure, which may not directly translate to the use of the Low Profile Companion Sheath.
Frequently Asked Questions
What is the Low Profile Companion Sheath used for?
It is used for delivering embolization coils during vascular procedures to occlude blood vessels.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in embolization procedures requiring the delivery of coils to occlude blood vessels.
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.