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inner-lock introducer sheath
Rex Medical
Summary: The inner-lock introducer sheath by Rex Medical is a device used in vascular interventions, primarily for embolization-coils. Key evidence highlights its role in revascularization techniques and its impact on hemodynamics during procedures.
FDA Clearance Information
Pathway
510K
Number
K051468 ↗
Decision Date
August 4, 2005
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The inner-lock introducer sheath was cleared by the FDA via the 510(k) pathway on August 4, 2005. It is manufactured by Rex Medical and classified as a Class 2 device.
What It Is
The inner-lock introducer sheath is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used in endovascular procedures, providing a stable conduit for device delivery.
Clinical Applications
Commonly used in procedures involving embolization-coils, the inner-lock introducer sheath is essential in mechanical thrombectomy and other vascular interventions. It provides access and support for various endovascular tools.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2022 to 2024, focusing on the device's application in vascular procedures.
Reported Outcomes
Published studies report the inner-lock introducer sheath's effectiveness in facilitating revascularization during mechanical thrombectomy and its role in managing radial artery occlusion. It has been shown to support successful outcomes in complex vascular interventions.
Safety Profile
Reported complications include potential occlusion of the sheath introducer by thrombus during procedures, as well as radial artery occlusion post-transradial access. These events highlight the need for careful monitoring during use.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to explore long-term outcomes and to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for inner-lock introducer sheath?
The device is indicated for use in vascular interventions, particularly in procedures involving embolization-coils and mechanical thrombectomy.
What outcomes have been reported in clinical studies?
Studies have reported successful revascularization and management of radial artery occlusion, demonstrating the device's efficacy in complex vascular procedures.
What complications have been reported?
Safety data indicate potential complications such as sheath introducer occlusion by thrombus and radial artery occlusion, necessitating careful procedural management.
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.