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vado steerable sheath
Kalila Medical
Summary: The Vado Steerable Sheath is a medical device used to facilitate access to specific areas within the vascular system, primarily for electrophysiological procedures. It is commonly used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K140420 ↗
Decision Date
April 1, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vado Steerable Sheath was cleared through the FDA 510(k) pathway on April 1, 2014. It is manufactured by Kalila Medical and classified as a Class 2 device under product code DYB.
What It Is
The Vado Steerable Sheath is a catheter-based device designed to provide enhanced maneuverability and access within the vascular system. It features a steerable tip that allows clinicians to navigate complex vascular pathways with precision. This device is particularly useful in procedures requiring access to the heart, such as electrophysiological studies and ablation therapies.
Clinical Applications
The Vado Steerable Sheath is commonly used in electrophysiology labs during procedures like catheter ablation for atrial fibrillation. It is also utilized in interventional cardiology and radiology settings to facilitate the delivery of therapeutic devices to targeted areas. The device is suitable for adult patients undergoing complex vascular interventions.
Indications for Use
The FDA indications suggest that the Vado Steerable Sheath is intended for use in procedures requiring access to the pulmonary veins, such as the treatment of paroxysmal atrial fibrillation. It is designed to aid in the navigation and positioning of catheters within the vascular system.
Practical Considerations
The Vado Steerable Sheath is available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard catheterization equipment and requires familiarity with steerable catheter techniques. Clinicians should ensure proper training in its use to maximize its benefits.
Related Literature
The linked study focused on evaluating the safety and performance of the Vado Steerable Sheath in accessing pulmonary veins for treating paroxysmal atrial fibrillation. Although the abstract is not available, the study likely assessed the device's effectiveness in facilitating catheter navigation and positioning. Limitations may include a lack of long-term outcome data and a small sample size.
Frequently Asked Questions
What is Vado Steerable Sheath used for?
The Vado Steerable Sheath is used to provide enhanced access and maneuverability within the vascular system, particularly for electrophysiological procedures like catheter ablation.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use the Vado Steerable Sheath in electrophysiology labs and interventional settings.
What are the FDA-cleared indications?
The device is indicated for use in accessing the pulmonary veins, particularly for procedures treating paroxysmal atrial fibrillation.
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.