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lumend frontrunner cto coronary catheter
Lumend
Summary: The Lumend Frontrunner CTO Coronary Catheter is designed for recanalization of chronic total occlusions in coronary arteries. Key evidence suggests improved success rates in CTO revascularization compared to conventional methods.
FDA Clearance Information
Pathway
510K
Number
K013284 ↗
Decision Date
February 11, 2002
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Lumend Frontrunner CTO Coronary Catheter was cleared by the FDA via the 510(k) pathway on February 11, 2002. It is manufactured by Lumend and classified as a Class 2 device under product code DQY.
What It Is
The Lumend Frontrunner CTO Coronary Catheter is a specialized device used to facilitate the recanalization of chronic total occlusions (CTOs) in coronary arteries. It is intended to improve the success rate of CTO revascularization procedures.
Clinical Applications
This device is commonly used in interventional cardiology for patients with chronic total occlusions in coronary arteries, particularly when conventional angioplasty equipment has limited success. It is utilized in scenarios where enhanced recanalization techniques are required.
Evidence Summary
The available literature includes two peer-reviewed studies published between 2006 and 2009. These studies focus on the efficacy and outcomes of using the Lumend Frontrunner catheter in CTO revascularization.
Reported Outcomes
Published studies report that the use of the Lumend Frontrunner catheter in recanalization of chronic total occlusions has shown improved success rates compared to conventional guidewires, with success rates increasing from 50-60% to 79-90%. The studies highlight the potential for reduced mortality associated with successful CTO revascularization.
Safety Profile
Reported complications include the typical risks associated with coronary catheterization procedures, although specific adverse events related to the Lumend Frontrunner catheter were not detailed in the provided studies.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed safety data. Further research is needed to establish long-term outcomes and to compare the efficacy of the Lumend Frontrunner catheter with other emerging technologies.
Frequently Asked Questions
What are the clinical indications for Lumend Frontrunner CTO Coronary Catheter?
The device is indicated for the recanalization of chronic total occlusions in coronary arteries, particularly in cases where conventional angioplasty techniques have limited success.
What outcomes have been reported in clinical studies?
Studies have reported improved success rates in CTO revascularization, with success rates increasing from 50-60% to 79-90% when using the Lumend Frontrunner catheter.
What complications have been reported?
Reported complications include general risks associated with coronary catheterization, but specific adverse events related to the device were not detailed in the studies.
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.