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Product: Turnpike — all models and sizes
Summary: Turnpike catheters by Vascular Solutions are used in complex vascular interventions. FDA-cleared under 510k pathway. Key evidence highlights potential complications in tortuous vessels.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K191560 ↗
Decision Date ?
August 9, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Turnpike catheters, manufactured by Vascular Solutions, were cleared by the FDA via the 510k pathway on August 9, 2019. They are classified as Class 2 devices under product code DQY.
What It Is
Turnpike catheters are microcatheters designed for navigating complex vascular pathways, particularly in percutaneous coronary interventions. They facilitate the delivery of therapeutic agents and devices through tortuous and calcified vessels.
FDA-Cleared Indications
- Used for percutaneous introduction into the vascular system to support the delivery of diagnostic or therapeutic devices and agents.
- Intended for use by physicians trained in percutaneous vascular procedures.
- The exact indication, vessel territory, compatible guidewire, and supported devices depend on the specific catheter model and its current labeling.
Clinical Applications
- Providing catheter support during percutaneous vascular intervention when vessel anatomy is tortuous or difficult to cross.
- Facilitating delivery of compatible guidewires, balloons, stents, embolic materials, or other interventional devices when permitted by the specific product labeling.
- Delivering diagnostic or therapeutic agents through a catheter during vascular procedures.
- Supporting coronary chronic total occlusion procedures and other complex endovascular interventions when the selected model is labeled for that application.
Reported off-label uses
- Use as a support or delivery catheter in peripheral arterial or venous interventions outside the specific vessel territories listed in the applicable labeling.
- Use in selected complex venous interventions, including difficult access or device-delivery cases, when determined appropriate by the treating physician.
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 use of Turnpike catheters in complex interventions.
Reported Outcomes
Published studies report that Turnpike catheters improve success rates in complex percutaneous coronary interventions. However, they also highlight the risk of complications such as microcatheter tip fracture, which can lead to acute vessel occlusion.
Safety Profile
Reported complications include microcatheter tip fracture and subsequent acute vessel occlusion, particularly in tortuous and calcified vessels. These events underscore the need for careful manipulation during procedures.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to better understand the long-term safety and efficacy of Turnpike catheters in diverse patient populations.
Practical Considerations
- Turnpike models differ in length, outer diameter, inner diameter, tip design, shaft characteristics, and support; select the model and size for the access route, target vessel, guidewire, and device being used.
- Use compatible guidewires and devices and follow the current instructions for use. Do not force the catheter through resistance, because tortuous or calcified vessels increase the risk of dissection, perforation, thrombosis, or device damage.
- The catheter is advanced under fluoroscopic or other appropriate imaging guidance through a vascular access sheath or guide catheter, commonly from femoral or radial access depending on the procedure.
- MRI safety and conditional-use details are model-specific and should be confirmed in the current manufacturer labeling before MRI.
- Potential complications include bleeding or hematoma at the access site, infection, thrombosis, embolization, vessel spasm, dissection, perforation, and allergic or kidney-related reactions to contrast when contrast is used.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Turnpike catheters?
Turnpike catheters are indicated for use in complex vascular interventions, particularly in navigating tortuous and calcified vessels during percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved success rates in complex interventions but also noted complications such as microcatheter tip fracture.
What complications have been reported?
Safety data from evidence indicates complications like microcatheter tip fracture and acute vessel occlusion, especially in challenging vessel anatomies.
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.