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turnpike catheter
Vascular Solution
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.
FDA Clearance Information
Pathway
510K
Number
K151981 ↗
Decision Date
August 13, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Turnpike Catheter was cleared by the FDA through the 510(k) pathway on August 13, 2015. It is manufactured by Vascular Solution and 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 and contrast media to targeted vascular sites.
Clinical Applications
Commonly used in complex percutaneous coronary interventions, the Turnpike Catheter assists in navigating challenging vascular pathways. It is particularly useful in cases requiring precise access to discrete vascular regions.
Evidence Summary
The literature includes various study types such as case reports and database analyses, with a focus on device performance and complications. Studies range from 2021 to 2024, providing insights into the catheter's clinical utility and safety profile.
Reported Outcomes
Published studies report that the Turnpike Catheter is effective in navigating complex vascular pathways, enhancing the success rate of interventions. However, its aggressive manipulation can lead to complications such as tip fracture and vessel occlusion.
Safety Profile
Reported complications include tip fracture and acute vessel occlusion, as highlighted in case studies. These events underscore the importance of careful handling during procedures.
Evidence Limitations
Current evidence is limited by the small number of studies focusing on specific complications. Further research is needed to explore long-term outcomes and optimize handling techniques to minimize risks.
Frequently Asked Questions
What are the clinical indications for Turnpike Catheter?
The Turnpike Catheter is indicated for 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 effective navigation of complex vascular pathways, improving intervention success rates, but also highlight potential complications like tip fracture.
What complications have been reported?
Safety data indicate complications such as tip fracture and acute vessel occlusion, emphasizing the need for careful device manipulation.
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.