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twin-pass dual access catheter
Vascular Solutions
Summary: The Twin-Pass Dual Access Catheter is a specialized tool used primarily by interventional cardiologists to manage coronary artery interventions. It facilitates distal coronary contrast injection without losing wire position, crucial in diagnosing and treating no-reflow phenomena.
FDA Clearance Information
Pathway
510K
Number
K193119 ↗
Decision Date
June 29, 2020
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Twin-Pass Dual Access Catheter received FDA clearance through the 510(k) pathway on June 29, 2020. Manufactured by Vascular Solutions, it is classified as a Class 2 device under product code DQY.
What It Is
The Twin-Pass Dual Access Catheter is a dual-lumen catheter designed for use in coronary interventions. It allows for simultaneous wire and contrast injection, which is particularly useful in cases where maintaining wire position is critical. This device is instrumental in diagnosing and managing complex coronary artery conditions, such as the no-reflow phenomenon, by providing enhanced visualization of the distal coronary vasculature.
Clinical Applications
Clinically, the Twin-Pass Dual Access Catheter is used in interventional cardiology, particularly during percutaneous coronary interventions (PCI). It is valuable in scenarios where there is a sudden loss of antegrade flow in a coronary artery, helping to diagnose and treat underlying pathologies. The device is typically used in catheterization labs by cardiologists dealing with complex coronary lesions or complications like no-reflow.
Indications for Use
The FDA indications for this catheter involve its use in coronary artery procedures where maintaining wire position is crucial while injecting contrast. It is particularly indicated for patients experiencing no-reflow or other complications during coronary interventions.
Practical Considerations
The Twin-Pass Dual Access Catheter is compatible with standard guidewires and coronary catheters. It is typically available in various lengths to accommodate different patient anatomies and procedural needs. Clinicians should be familiar with dual-lumen catheter techniques to maximize its utility.
Related Literature
The linked study examined the use of the Twin-Pass Dual Access Catheter in assessing the no-reflow phenomenon during coronary interventions. It highlighted the device's ability to maintain wire position while allowing distal contrast injection, aiding in the diagnosis of underlying pathologies causing no-reflow. However, the study was limited by its focus on a specific clinical scenario and did not explore broader applications or long-term outcomes.
Frequently Asked Questions
What is the Twin-Pass Dual Access Catheter used for?
It is used in coronary interventions to maintain wire position while injecting contrast, crucial for diagnosing and managing no-reflow phenomena.
What specialties typically use this device?
Interventional cardiologists primarily use this device during percutaneous coronary interventions.
What are the FDA-cleared indications?
The catheter is indicated for use in coronary artery procedures where maintaining wire position and injecting contrast are necessary, particularly in cases of no-reflow.
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.