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cardiocurve steerable sheath
Talon Surgical
Summary: The cardiocurve steerable sheath by Talon Surgical is a device used primarily in embolization procedures. Key evidence highlights its role in reducing fluoroscopy time during atrial fibrillation ablations.
FDA Clearance Information
Pathway
510K
Number
K210185 ↗
Decision Date
July 23, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The cardiocurve steerable sheath was cleared by the FDA through the 510(k) pathway on July 23, 2021. It is manufactured by Talon Surgical and classified as a Class 2 device.
What It Is
The cardiocurve steerable sheath is a medical device designed to facilitate catheter navigation during embolization procedures. It allows for precise control and positioning, enhancing procedural efficiency and safety.
Clinical Applications
Commonly used in procedures requiring embolization coils, the steerable sheath is particularly beneficial in atrial fibrillation ablations, where it helps reduce fluoroscopy exposure and improve catheter placement accuracy.
Evidence Summary
The literature includes 10 studies, comprising randomized controlled trials and observational studies, published between 2022 and 2024. These studies explore the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report that the cardiocurve steerable sheath significantly reduces fluoroscopy time and improves procedural efficiency in atrial fibrillation ablations. It also facilitates better catheter positioning and mapping accuracy.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. The device's design helps mitigate radiation exposure risks during procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to explore long-term outcomes and broader clinical applications.
Frequently Asked Questions
What are the clinical indications for cardiocurve steerable sheath?
The device is indicated for use in embolization procedures, particularly in atrial fibrillation ablations to reduce fluoroscopy time and improve catheter placement.
What outcomes have been reported in clinical studies?
Studies have reported reduced fluoroscopy times, improved procedural efficiency, and enhanced catheter positioning accuracy.
What complications have been reported?
Safety data from evidence indicates minimal adverse events, with a favorable safety profile and reduced radiation exposure.
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.