📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Facilitate the introduction and guidance of compatible diagnostic or therapeutic devices during endovascular procedures.
- Facilitate navigation and positioning of compatible devices during endobronchial procedures.
Clinical Applications
- Guidance and positioning of compatible devices in endovascular procedures.
- Guidance and positioning of compatible devices in endobronchial procedures.
Reported off-label uses
- Steerable access for targeted intramyocardial injection procedures has been described in clinical practice.
- Steerable navigation for bronchoscopic or endobronchial lung biopsy procedures has been described, depending on the specific system and labeling.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The available sizes, working length, tip configuration, and deflection range depend on the specific product model; users should verify the current instructions for use.
- Compatibility with guidewires, catheters, injection systems, and other devices must be confirmed before use.
- The sheath is manipulated under appropriate imaging guidance, such as fluoroscopy or endoscopic visualization, depending on the procedure.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is safe in an MRI scanner.
- Potential complications are related to vascular or airway access and may include bleeding, vessel or airway injury, infection, thrombosis, embolization, perforation, or device malfunction.
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.