📊 Evidence-Based Reference
Turnpike Catheter
Summary: The Turnpike Catheter is a microcatheter designed for accessing discrete regions of the coronary and peripheral vasculature. It is primarily used in complex percutaneous coronary interventions. Key evidence highlights its trackability and potential complications such as tip fracture.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142065 ↗
Decision Date ?
November 25, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Turnpike Catheter was cleared by the FDA via the 510(k) pathway on November 25, 2014. It is manufactured by Vascular Solutions and is classified as a Class 2 device.
What It Is
The Turnpike Catheter is a microcatheter used to navigate through tortuous and calcified vessels in coronary and peripheral interventions. It is designed to facilitate the delivery of therapeutic devices to targeted vascular regions.
FDA-Cleared Indications
- For use in the coronary and peripheral vasculature.
- Used to access discrete vascular regions during percutaneous interventions.
- Intended to facilitate the delivery of therapeutic devices or agents to targeted vascular locations.
Clinical Applications
- Selective access to coronary arteries during percutaneous coronary intervention.
- Selective access to peripheral arteries during endovascular intervention.
- Delivery of compatible therapeutic devices or agents to a targeted vascular region.
- Navigation through anatomically difficult vascular pathways when selective catheter access is needed.
Reported off-label uses
- Support for complex chronic total occlusion crossing or re-entry techniques in coronary or peripheral arteries.
- Use as an auxiliary catheter for difficult lesion crossing or device delivery beyond the labeled general vascular-access indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The literature includes 10 studies ranging from 2021 to 2024, encompassing various study types such as retrospective analyses and case reports. These studies explore the catheter's performance, complications, and clinical applications.
Reported Outcomes
Published studies report that the Turnpike Catheter is effective in navigating complex vascular pathways, enhancing the success rate of interventions. However, complications such as tip fracture and acute vessel occlusion have been documented.
Safety Profile
Reported complications include tip fracture leading to vessel occlusion, as highlighted in case reports. The MAUDE database analysis provides insights into potential failure mechanisms.
Evidence Limitations
Current evidence is limited by the small number of prospective studies and a reliance on retrospective data. Further research is needed to explore long-term outcomes and optimize safety profiles.
Practical Considerations
- The catheter is used with compatible guidewires, guide catheters, and interventional devices; compatibility should be confirmed in the current instructions for use.
- Available configurations may differ by model, including catheter length, inner diameter, outer diameter, tip design, and torque or support characteristics.
- It is a single-use catheter and should be advanced under fluoroscopic guidance by trained clinicians; excessive force or sharp angulation can cause vessel injury or catheter damage, including tip fracture.
- MRI safety depends on the specific model and labeling. Confirm the current manufacturer MRI information before scanning; do not assume the catheter is MR safe or MR conditional.
- Contraindications, warnings, and limitations include inability to safely access the target vessel, unsuitable vessel anatomy, incompatibility with the planned device or agent, and patient-specific risks of angiography or endovascular treatment.
Frequently Asked Questions
What are the clinical indications for Turnpike Catheter?
The Turnpike Catheter is indicated for use in accessing discrete regions of the coronary and peripheral vasculature, particularly in complex percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Studies report improved navigation through complex vascular pathways, though complications such as tip fracture have been noted.
What complications have been reported?
Safety data indicate complications such as tip fracture and vessel occlusion, as documented in case reports and database analyses.
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.