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extesia introducer sheath set
Curatia Medical
Summary: The Extesia Introducer Sheath Set by Curatia Medical is a device used in embolization procedures. It was FDA-cleared via the 510k pathway in 2022. Key evidence includes studies on its use in endovascular repairs and associated outcomes.
FDA Clearance Information
Pathway
510K
Number
K220604 ↗
Decision Date
April 27, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Extesia Introducer Sheath Set was cleared by the FDA through the 510k pathway on April 27, 2022. It is manufactured by Curatia Medical and classified as a Class 2 device.
What It Is
The Extesia Introducer Sheath Set is designed for use in embolization procedures, particularly involving coils. It facilitates the introduction of devices into the vascular system, providing a conduit for catheter-based interventions.
Clinical Applications
Commonly used in endovascular procedures, the Extesia Introducer Sheath Set is employed in scenarios requiring precise vascular access, such as in the treatment of aneurysms or during complex aortic repairs.
Evidence Summary
The available literature includes 10 studies ranging from 2005 to 2025, encompassing various study types such as RCTs, prospective, and retrospective studies. These studies explore the device's application in vascular interventions.
Reported Outcomes
Published studies report the Extesia Introducer Sheath Set as effective in facilitating endovascular procedures, with particular success in complex aortic repairs. Outcomes include improved procedural efficiency and successful device deployment.
Safety Profile
Reported complications include concerns about long-term limb patency and potential for limb occlusions, as noted in studies involving similar devices. Overall, the device is considered safe with proper technique.
Evidence Limitations
Evidence gaps include a lack of large-scale RCTs specifically focused on the Extesia Introducer Sheath Set. Further research is needed to assess long-term outcomes and comparative effectiveness against other introducer sheaths.
Frequently Asked Questions
What are the clinical indications for Extesia Introducer Sheath Set?
The device is indicated for use in embolization procedures, particularly with coils, and in endovascular interventions requiring vascular access.
What outcomes have been reported in clinical studies?
Studies report effective facilitation of endovascular procedures, with successful device deployment and improved procedural efficiency.
What complications have been reported?
Safety data indicate potential complications such as limb occlusions and concerns about long-term limb patency, though these are generally manageable with proper technique.
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.