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Vascular Solutions
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
510K
Number
K191560 ↗
Decision Date
August 9, 2019
Product Code
DQY
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.
Clinical Applications
These catheters are commonly used in procedures involving chronic total occlusions and other challenging vascular conditions. They are particularly useful in scenarios requiring precise navigation through difficult vessel anatomy.
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.
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.