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guide sheath
Surmodics
Summary: The guide sheath by Surmodics is used primarily in endobronchial ultrasound-guided procedures for diagnosing peripheral pulmonary lesions. Key evidence highlights its role in improving diagnostic yield.
FDA Clearance Information
Pathway
510K
Number
K190644 ↗
Decision Date
April 18, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The guide sheath by Surmodics was cleared through the FDA 510(k) pathway on April 18, 2019. It is classified as a Class 2 device under product code DYB.
What It Is
The guide sheath is a medical device designed to facilitate endobronchial ultrasound-guided procedures. It aids in the precise navigation and biopsy of peripheral pulmonary lesions by providing a stable pathway for instruments.
Clinical Applications
Commonly used in pulmonology, the guide sheath assists in endobronchial ultrasound-guided transbronchial biopsies. It is particularly beneficial in diagnosing peripheral pulmonary lesions.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs and retrospective analyses, published between 2004 and 2024. These studies focus on the diagnostic yield and safety of the guide sheath.
Reported Outcomes
Published studies report that the guide sheath improves the diagnostic yield of peripheral pulmonary lesions when used in endobronchial ultrasound-guided procedures. It is associated with enhanced accuracy in biopsy procedures.
Safety Profile
Reported complications include guide sheath breakage during procedures, which may require surgical intervention for removal. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
Evidence gaps include limited long-term safety data and a need for more large-scale prospective studies. Some studies lack detailed outcome measures, which could enhance understanding of efficacy.
Frequently Asked Questions
What are the clinical indications for guide sheath?
The guide sheath is indicated for use in endobronchial ultrasound-guided procedures to diagnose peripheral pulmonary lesions.
What outcomes have been reported in clinical studies?
Studies report improved diagnostic yield and accuracy in biopsies of peripheral pulmonary lesions using the guide sheath.
What complications have been reported?
Safety data indicate rare occurrences of guide sheath breakage, which may necessitate surgical removal.
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.