đź“‹ FDA Reference
asahi tornus support catheter with torque device accessory
Asahi Intecc
Summary: The Asahi Tornus Support Catheter is a specialized device used primarily in interventional cardiology to assist in crossing challenging vascular lesions. It is utilized by cardiologists and interventional radiologists in procedures involving chronic total occlusions.
FDA Clearance Information
Pathway
510K
Number
K060745 ↗
Decision Date
June 23, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Asahi Tornus Support Catheter was cleared through the FDA 510(k) pathway on June 23, 2006. Manufactured by Asahi Intecc, it is classified as a Class 2 medical device under product code DQY.
What It Is
The Asahi Tornus Support Catheter is a specialized support catheter designed to aid in the crossing of difficult vascular lesions, particularly in cases where standard balloon catheters fail. It features a unique metal construction that provides enhanced penetration capabilities, making it suitable for navigating through calcified or occluded vessels. The device is equipped with a torque device accessory to facilitate precise maneuvering and control during procedures.
Clinical Applications
The Tornus Support Catheter is commonly used in interventional cardiology and radiology, particularly for patients with chronic total occlusions (CTOs) or heavily calcified lesions. It is often employed in catheterization labs during percutaneous coronary interventions (PCIs) when standard techniques are insufficient. The device is particularly beneficial in treating patients with complex coronary artery disease, providing an alternative approach to traditional balloon angioplasty.
Indications for Use
The FDA-cleared indications for the Tornus Support Catheter include its use in procedures requiring the crossing of challenging vascular lesions, such as chronic total occlusions or calcified stenoses. It is intended for patients who have not responded to conventional balloon catheter techniques.
Practical Considerations
The Tornus Support Catheter is available in various sizes to accommodate different patient anatomies and lesion characteristics. It is compatible with standard guidewires and can be used in conjunction with other interventional devices. Clinicians should be familiar with its torque mechanism to optimize device handling and lesion crossing.
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 occluded lesions. The study found that the Tornus catheter successfully facilitated lesion crossing in these challenging scenarios. However, the study's limitations include its retrospective nature and the lack of a control group, which may affect the generalizability of the findings.
Frequently Asked Questions
What is the Asahi Tornus Support Catheter used for?
It is used to assist in crossing difficult vascular lesions, such as chronic total occlusions or calcified stenoses, particularly when standard balloon catheters are ineffective.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use the Tornus Support Catheter in catheterization labs during complex coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in crossing challenging vascular lesions, such as chronic total occlusions or calcified stenoses, especially when conventional balloon techniques fail.
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.