đź“Š Evidence-Based Reference
turnpike catheter turnpike spiral catheter turnpike lp catheter turnpike gold catheter guideliner v3 catheter trapliner catheter
Vascular Solutions
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
510K
Number
K212211 ↗
Decision Date
February 9, 2022
Product Code
DQY
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.
Clinical Applications
Commonly used in percutaneous coronary interventions, the Turnpike catheter is particularly valuable in procedures involving chronic total occlusions and heavily calcified or tortuous vessels. It aids in the precise delivery of interventional tools to the target site.
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.
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.