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biocardia morph sheath guide
Biocardia
Summary: The Biocardia Morph Sheath Guide is a steerable guide sheath used in endovascular and endobronchial procedures. Key evidence highlights its role in precise targeting for lung biopsy and intramyocardial injections.
FDA Clearance Information
Pathway
510K
Number
K090999 ↗
Decision Date
April 15, 2009
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Biocardia Morph Sheath Guide was cleared by the FDA via the 510(k) pathway on April 15, 2009. It is manufactured by Biocardia and classified as a Class 2 device under product code DYB.
What It Is
The Biocardia Morph Sheath Guide is a steerable sheath designed to facilitate the delivery of diagnostic and therapeutic devices in endovascular and endobronchial procedures. It is intended for use in procedures requiring precise navigation and positioning.
Clinical Applications
Common clinical scenarios for the Biocardia Morph Sheath Guide include endobronchial navigation for lung biopsy and intramyocardial injections. It is particularly useful in procedures that require enhanced maneuverability and precision.
Evidence Summary
The available literature includes two studies, one from 2013 and another projected for 2025. These studies encompass a range of methodologies including RCTs and case series, focusing on the device's application in endobronchial and cardiac procedures.
Reported Outcomes
Published studies report that the Biocardia Morph Sheath Guide enhances accuracy in endobronchial targeting for lung biopsy and improves the precision of intramyocardial injections. The device's steerability is highlighted as a key factor in achieving successful outcomes.
Safety Profile
Reported complications include potential navigation challenges in complex anatomical structures. However, the studies reviewed did not report significant adverse events directly attributable to the device.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale RCTs. Further research is needed to validate findings across diverse patient populations and to explore long-term outcomes.
Frequently Asked Questions
What are the clinical indications for Biocardia Morph Sheath Guide?
The device is indicated for use in endobronchial navigation for lung biopsy and intramyocardial injections.
What outcomes have been reported in clinical studies?
Studies report improved accuracy in lung biopsy targeting and precision in cardiac injections.
What complications have been reported?
Reported complications include navigation challenges, but no significant adverse events were directly linked to the device.
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.