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peripheral guiding sheath
Micrus Design Technology
Summary: The peripheral guiding sheath by Micrus Design Technology is used primarily in embolization procedures. Key evidence highlights its utility in peripheral pulmonary lesions with augmented fluoroscopy.
FDA Clearance Information
Pathway
510K
Number
K070816 ↗
Decision Date
September 19, 2007
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The peripheral guiding sheath was cleared through the FDA 510(k) pathway on September 19, 2007. It is manufactured by Micrus Design Technology and classified as a Class 2 device.
What It Is
The peripheral guiding sheath is a medical device designed to facilitate the delivery of embolization coils. It is used in interventional radiology to provide access and support for catheter-based procedures.
Clinical Applications
Commonly used in procedures requiring precise catheter placement, such as embolization of vascular lesions. It is particularly useful in navigating complex vascular anatomy.
Evidence Summary
The literature includes 9 studies, encompassing various study types such as RCTs and case series, with publication dates ranging from 2015 to 2022.
Reported Outcomes
Published studies report the peripheral guiding sheath's effectiveness in enhancing procedural accuracy in peripheral pulmonary lesions. It has shown promise in improving outcomes in bronchoscopy and needle biopsy procedures.
Safety Profile
Reported complications include potential risks associated with catheter-based interventions, such as vascular injury or device malposition. However, specific adverse events were not detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for the peripheral guiding sheath?
The device is indicated for use in embolization procedures, particularly in the context of vascular lesions requiring precise catheter navigation.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural accuracy and outcomes in peripheral pulmonary lesion interventions using the guiding sheath.
What complications have been reported?
Safety data indicate potential complications such as vascular injury, though specific adverse events were not detailed in the studies.
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.