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turnpike catheter
Vascular Solutions
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
510K
Number
K142065 ↗
Decision Date
November 25, 2014
Product Code
DQY
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.
Clinical Applications
Commonly used in complex percutaneous coronary interventions, the Turnpike Catheter aids in accessing challenging vascular pathways. It is particularly useful in cases with heavily calcified or tortuous vessels.
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.
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.