📋 FDA Reference
Asahi Tornus Support Catheter with Torque Device Accessory
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 ?
510(k)
Number ?
K060745 ↗
Decision Date ?
June 23, 2006
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used during percutaneous vascular procedures to provide catheter support and assist in crossing difficult lesions.
- Intended for use with compatible guidewires and other interventional devices during catheter-based treatment.
- The FDA 510(k) summary supports use as a percutaneous catheter; specific clinical uses should be confirmed in the current manufacturer labeling.
Clinical Applications
- Providing support for guidewire and catheter advancement across difficult vascular lesions.
- Assisting catheter-based treatment when standard catheter or balloon techniques do not provide adequate support.
- Navigating lesions that are challenging because of obstruction, tortuosity, or calcification, when consistent with the current device labeling.
Practical Considerations
- The device is used over a compatible guidewire and may be paired with other interventional catheters or devices.
- The torque device is intended to help the operator control catheter rotation and advancement; careful handling is required to avoid vessel injury or device damage.
- Available sizes and usable lengths should be matched to the access route, vessel diameter, guidewire, and target lesion.
- MRI safety depends on the exact model, materials, and labeling. Do not assume the device is MR safe or MR conditional without reviewing the current manufacturer instructions for use.
- Contraindications, warnings, and limitations should be taken from the current Asahi Intecc labeling; potential catheter-procedure risks include bleeding, vessel injury, perforation, thrombosis, embolization, infection, and contrast-related complications.
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.