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torflex transseptal guiding sheath
Baylis Medical
Summary: The Torflex Transseptal Guiding Sheath is a medical device used to facilitate access to the left atrium of the heart. It is primarily used by cardiologists and electrophysiologists during procedures such as catheter ablation.
FDA Clearance Information
Pathway 510K
Number K102948 ↗
Decision Date April 1, 2011
Product Code DYB
Device Class Class 2
Evidence 0 studies
The Torflex Transseptal Guiding Sheath was cleared through the FDA 510k pathway on April 1, 2011. It is manufactured by Baylis Medical and classified as a Class 2 device under product code DYB.
What It Is
The Torflex Transseptal Guiding Sheath is a specialized catheter designed to provide a stable and flexible pathway for instruments to cross the atrial septum into the left atrium. It is used in procedures requiring precise access to the left side of the heart, such as catheter ablation for atrial fibrillation. The sheath's design allows for improved maneuverability and control, which is crucial in delicate cardiac procedures.
Clinical Applications
This device is commonly used in interventional cardiology and electrophysiology labs. It is essential for procedures like transseptal catheterization, where access to the left atrium is required. Cardiologists and electrophysiologists use it primarily in the treatment of arrhythmias, particularly atrial fibrillation, and in the placement of devices such as left atrial appendage occlusion devices. It is suitable for adult patients requiring these interventions.
Indications for Use
The FDA indications for the Torflex Transseptal Guiding Sheath include facilitating access to the left atrium for diagnostic and therapeutic procedures. It is intended for use in patients undergoing procedures that require crossing the atrial septum, such as catheter ablation.
Practical Considerations
The Torflex sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard transseptal needles and catheters. Clinicians should be familiar with transseptal puncture techniques and the associated anatomical considerations to ensure safe and effective use.
Frequently Asked Questions
What is the Torflex Transseptal Guiding Sheath used for?
The Torflex Transseptal Guiding Sheath is used to facilitate access to the left atrium during cardiac procedures such as catheter ablation.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in interventional cardiology and electrophysiology procedures.
What are the FDA-cleared indications?
The device is indicated for facilitating access to the left atrium for diagnostic and therapeutic procedures requiring transseptal catheterization.
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.