đź“Š Evidence-Based Reference
super sheath introducer sheath and super sheath introducer sheath sets
Togo Medikit
Summary: The super sheath introducer sheath by Togo Medikit is a Class 2 medical device cleared by the FDA for use in embolization-coils. Key evidence highlights its application in vascular procedures, with studies exploring its safety and efficacy.
FDA Clearance Information
Pathway
510K
Number
K121504 ↗
Decision Date
September 27, 2012
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The super sheath introducer sheath was cleared through the FDA 510(k) pathway on September 27, 2012. Manufactured by Togo Medikit, it is classified as a Class 2 device.
What It Is
The super sheath 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 embolization procedures and is intended to provide a conduit for diagnostic and interventional tools.
Clinical Applications
Common clinical scenarios for the super sheath introducer sheath include its use in embolization-coil procedures, where precise vascular access is required. It is particularly useful in complex vascular interventions where stability and flexibility are critical.
Evidence Summary
The available literature includes five studies, ranging from case reports to experimental studies, conducted between 2014 and 2025. These studies examine various aspects of the sheath's application, including safety and procedural outcomes.
Reported Outcomes
Published studies report the super sheath introducer sheath's effectiveness in facilitating vascular access during complex procedures. One study highlighted its role in femoro-femoral bypass for acute limb ischemia, while another explored its use in CT-guided pulmonary artery catheterization in a porcine model.
Safety Profile
Reported complications include vascular injury leading to occlusion, as seen in a case of transcatheter aortic valve implantation. Another study noted challenges in advancing occluders through the sheath, indicating potential limitations in certain procedural contexts.
Evidence Limitations
The evidence is limited by the small number of studies and the variability in study design, including case reports and experimental models. Further research is needed to establish standardized safety and efficacy profiles across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for super sheath introducer sheath?
The device is indicated for use in embolization-coil procedures, providing vascular access for diagnostic and interventional tools.
What outcomes have been reported in clinical studies?
Studies have reported effective vascular access and procedural success in complex interventions, such as femoro-femoral bypass and CT-guided catheterization.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and challenges in advancing occluders, highlighting the need for careful procedural planning.
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.