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Product: Turnpike — all models and sizes
Summary: The Turnpike catheter, manufactured by Vascular Solutions, is used in complex percutaneous coronary interventions. Key evidence highlights its utility in navigating tortuous vessels but also notes potential complications such as tip fracture.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K212211 ↗
Decision Date ?
February 9, 2022
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Turnpike catheter received FDA clearance through the 510(k) pathway on February 9, 2022. It is manufactured by Vascular Solutions and classified as a Class 2 device.
What It Is
The Turnpike catheter is a microcatheter designed to facilitate the navigation of complex and tortuous vascular pathways during percutaneous coronary interventions. It is intended for use in advancing guidewires and other interventional devices through challenging vascular anatomy.
FDA-Cleared Indications
- Percutaneous catheter use in the vascular system as described by the device labeling.
- Use to facilitate the placement, advancement, or exchange of guidewires and interventional devices during catheter-based procedures.
- Use under imaging guidance by appropriately trained medical professionals.
Clinical Applications
- Catheter-based vascular procedures requiring support for guidewire or device advancement.
- Percutaneous coronary interventions involving difficult, tortuous, or otherwise challenging vessel anatomy, when consistent with the applicable product labeling.
- Procedures requiring improved guidewire support or device delivery through a vascular access route.
Reported off-label uses
- Use of microcatheter-type Turnpike devices in selected peripheral vascular interventions is reported in clinical practice, but the specific indication should be confirmed against the labeling for the individual model.
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 available literature includes two studies, one published in 2021 and another in 2024. These studies encompass various methodologies, including case reports and registry analyses, focusing on the catheter's application in complex coronary interventions.
Reported Outcomes
Published studies report that the Turnpike catheter is effective in navigating complex vascular anatomy, enhancing the success rate of percutaneous coronary interventions. However, its aggressive manipulation can lead to complications such as microcatheter tip fracture.
Safety Profile
Reported complications include microcatheter tip fracture, which may result in acute vessel occlusion. Such events underscore the need for careful handling and awareness of potential risks during use.
Evidence Limitations
Current evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the long-term safety and efficacy of the Turnpike catheter in diverse patient populations.
Practical Considerations
- The Turnpike product family includes models with different lengths, distal-tip profiles, shaft characteristics, and lumen or inner-diameter specifications; confirm the exact model and compatibility before use.
- Use only with guidewires and other devices whose diameter and compatibility are specified in the applicable instructions for use.
- Advance and withdraw the catheter under fluoroscopic or other appropriate imaging guidance. Excessive force, resistance, torque, or advancement against an obstructed device can cause vessel injury or catheter damage.
- Potential complications of catheter-based vascular procedures include bleeding, hematoma, thrombosis, embolization, vessel dissection or perforation, infection, and device malfunction or fracture.
- MRI safety and conditions are model-specific. Review the current manufacturer labeling before an MRI examination; do not assume that the device is MR Safe or MR Conditional without documentation.
Frequently Asked Questions
What are the clinical indications for Turnpike catheter?
The Turnpike catheter is indicated for use in complex percutaneous coronary interventions, particularly in navigating tortuous and calcified vessels.
What outcomes have been reported in clinical studies?
Studies have reported successful navigation of complex vascular anatomy, improving the success rate of interventions, but also note potential complications.
What complications have been reported?
Safety data indicate complications such as microcatheter tip fracture, which can lead to acute vessel occlusion.
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.