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x-sept transseptal sheath and transition catheter model mv-03-09-90 mv-03-10-90 mv-03-11-90 mv-03-09-120 mv-03-10-1
Appriva Medical
Summary: The x-sept transseptal sheath by Appriva Medical is designed for transseptal access in cardiac procedures. Key evidence highlights its facilitation of interatrial crossing with minimal tissue resistance.
FDA Clearance Information
Pathway
510K
Number
K002054 ↗
Decision Date
February 16, 2001
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The x-sept transseptal sheath was cleared via the FDA 510(k) pathway on February 16, 2001. Manufactured by Appriva Medical, it is classified as a Class 2 device.
What It Is
The x-sept transseptal sheath is a medical device used to facilitate transseptal access in cardiac procedures. It is designed to minimize tissue resistance during sheath-dilator transitions, aiding in efficient interatrial crossing.
Clinical Applications
Commonly used in procedures requiring left atrial access, such as catheter ablation for atrial fibrillation, the x-sept sheath supports the introduction of large delivery sheaths through the septum.
Evidence Summary
The literature includes four studies ranging from 1989 to 2021, comprising RCTs, prospective, retrospective, and case series. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the x-sept transseptal sheath facilitates smooth transseptal access, improving procedural efficiency. The device's design reduces tissue resistance, aiding in the successful introduction of large sheaths.
Safety Profile
Reported complications include rare instances of foreign body-like structures post-procedure, though these are not directly attributed to the device. Overall, the device is considered safe with minimal adverse events.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term follow-up studies. Further research is needed to confirm findings and explore additional clinical applications.
Frequently Asked Questions
What are the clinical indications for x-sept transseptal sheath?
The device is indicated for use in procedures requiring transseptal access, such as catheter ablation for atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies report improved procedural efficiency and successful sheath introduction with minimal tissue resistance.
What complications have been reported?
Safety data indicate rare occurrences of foreign body-like structures post-procedure, though these are not 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.