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vado steerable sheath
Kalila Medical
Summary: The Vado Steerable Sheath is a medical device used to facilitate access to the heart's pulmonary veins, primarily for electrophysiological procedures. It is commonly used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K160721 ↗
Decision Date
March 7, 2017
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Vado Steerable Sheath by Kalila Medical was cleared via the FDA 510k pathway on March 7, 2017. It is classified as a Class 2 device under product code DYB.
What It Is
The Vado Steerable Sheath is a specialized catheter designed to provide flexible and precise access to the pulmonary veins. It features a steerable tip that allows clinicians to navigate complex vascular pathways with enhanced control. This device is particularly useful in procedures requiring precise catheter placement, such as catheter ablations for atrial fibrillation.
Clinical Applications
The Vado Steerable Sheath is commonly used in electrophysiology labs during procedures like catheter ablation for atrial fibrillation. It is particularly beneficial in complex cases where precise navigation of the heart's anatomy is required. Cardiologists and electrophysiologists use this device to improve access and stability during interventions, especially in adult patients with arrhythmias.
Indications for Use
The FDA indications for the Vado Steerable Sheath involve its use in accessing the pulmonary veins, which is crucial for treating conditions like paroxysmal atrial fibrillation. This device is intended for patients undergoing electrophysiological interventions.
Practical Considerations
The Vado Steerable Sheath is available in various sizes to accommodate different patient anatomies. It is compatible with standard electrophysiology catheters and requires familiarity with steerable sheath techniques for optimal use. Clinicians should ensure proper training in the device's manipulation to maximize its benefits.
Related Literature
The linked study evaluated the safety and performance of the Vado Steerable Sheath in accessing pulmonary veins for treating paroxysmal atrial fibrillation. Although specific results and the study year are not available, such studies typically assess the device's efficacy in improving procedural outcomes and reducing complications. Limitations may include a small sample size or lack of long-term follow-up data.
Frequently Asked Questions
What is Vado Steerable Sheath used for?
It is used to facilitate access to the pulmonary veins during electrophysiological procedures, such as catheter ablation for atrial fibrillation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use the Vado Steerable Sheath during cardiac interventions.
What are the FDA-cleared indications?
The device is indicated for use in accessing the pulmonary veins, particularly in procedures addressing 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.