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asahi tornus support catheter
Asahi Intecc
Summary: The Asahi Tornus Support Catheter is a specialized device used in interventional cardiology to assist in crossing challenging vascular lesions, particularly in cases of chronic total occlusions. It is primarily used by interventional cardiologists.
FDA Clearance Information
Pathway
510K
Number
K051772 ↗
Decision Date
September 26, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Tornus Support Catheter was cleared through the FDA 510(k) pathway on September 26, 2005. It is manufactured by Asahi Intecc and classified as a Class 2 medical device.
What It Is
The Asahi Tornus Support Catheter is a metal penetration catheter designed to provide support and facilitate the crossing of difficult vascular lesions, such as calcified stenoses or chronic total occlusions. It features a unique design that allows it to penetrate and navigate through tough, fibrotic, or calcified tissue where traditional balloon catheters may fail. This device is particularly useful in complex percutaneous coronary interventions (PCI).
Clinical Applications
The Tornus Support Catheter is commonly used in interventional cardiology, particularly in procedures involving chronic total occlusions (CTOs) where standard techniques have failed. It is employed in catheterization labs by interventional cardiologists to enhance the success rate of crossing challenging lesions. The device is beneficial for patients with complex coronary artery disease, especially those with heavily calcified or fibrotic lesions.
Indications for Use
The FDA indications for the Tornus Support Catheter include its use in facilitating the crossing of difficult vascular lesions, such as those found in chronic total occlusions. It is intended for patients who have lesions that are resistant to conventional balloon catheter techniques.
Practical Considerations
The Tornus Support Catheter is available in various sizes to accommodate different vessel diameters and lesion complexities. It is compatible with standard guidewires and requires careful manipulation to avoid vessel injury. Clinicians should be familiar with its unique handling characteristics and ensure proper technique during use.
Related Literature
A study conducted between December 2004 and November 2007 evaluated the Tornus catheter as a bail-out device in 44 cases where balloon catheters failed to cross calcified or chronically occluded lesions. The study found that the Tornus catheter was effective in these challenging scenarios, providing a valuable tool for interventional cardiologists. However, the study was limited by its retrospective design and small sample size.
Frequently Asked Questions
What is the Asahi Tornus Support Catheter used for?
It is used to assist in crossing difficult vascular lesions, particularly in cases of chronic total occlusions, during interventional cardiology procedures.
What specialties typically use this device?
The device is primarily used by interventional cardiologists in catheterization labs.
What are the FDA-cleared indications?
The device is indicated for use in facilitating the crossing of difficult vascular lesions, such as calcified stenoses or chronic total occlusions, where conventional balloon catheters have failed.
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.