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twin-pass torque
Vascular Solutions
Summary: The Twin-Pass Torque is a dual-lumen microcatheter used in interventional cardiology and radiology for accessing and treating complex vascular lesions. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K162467 ↗
Decision Date
February 1, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Twin-Pass Torque received FDA clearance through the 510(k) pathway on February 1, 2017. Manufactured by Vascular Solutions, it is classified as a Class 2 device under product code DQY.
What It Is
The Twin-Pass Torque is a specialized dual-lumen microcatheter designed to facilitate the delivery of guidewires and therapeutic agents in complex vascular interventions. It features a torqueable shaft that enhances maneuverability and precision in navigating tortuous vascular anatomy. This device is particularly useful in procedures requiring access to challenging lesions in coronary and peripheral vessels.
Clinical Applications
The Twin-Pass Torque is commonly used in interventional cardiology and radiology for procedures such as angioplasty and stent placement in both coronary and peripheral arteries. It is particularly beneficial in cases where standard catheters cannot easily access the target site due to anatomical complexities. This device is often employed in hospital catheterization labs and interventional radiology suites, serving patients with complex vascular conditions.
Indications for Use
The FDA-cleared indications for the Twin-Pass Torque involve its use in accessing and treating complex vascular lesions. It is indicated for patients requiring precise delivery of guidewires or therapeutic agents in coronary or peripheral interventions.
Practical Considerations
The Twin-Pass Torque is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and requires careful handling to maximize its torqueability and navigation capabilities. Clinicians should be familiar with dual-lumen catheter techniques to optimize its use.
Frequently Asked Questions
What is Twin-Pass Torque used for?
The Twin-Pass Torque is used for accessing and treating complex vascular lesions, particularly in coronary and peripheral interventions.
What specialties typically use this device?
Interventional cardiologists and interventional radiologists typically use the Twin-Pass Torque.
What are the FDA-cleared indications?
The device is indicated for use in accessing and treating complex vascular lesions in coronary and peripheral interventions.
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.