đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K013284 ↗
Decision Date ?
February 11, 2002
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Intended for use in the recanalization of chronic total occlusions in coronary arteries.
- Used during percutaneous coronary intervention to facilitate crossing or opening an occluded coronary artery.
- The device is a percutaneous catheter classified under FDA product code DQY.
Clinical Applications
- Facilitating recanalization of chronic total occlusions in coronary arteries.
- Supporting percutaneous coronary intervention when conventional equipment cannot readily cross the occlusion.
- Helping restore coronary artery access before balloon angioplasty or coronary stent placement, when clinically appropriate.
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.
Practical Considerations
- The catheter is intended for coronary use and should be used only by appropriately trained interventional cardiology teams.
- Use requires fluoroscopic or other appropriate angiographic imaging, coronary guidewire access, and compatibility with the planned guide catheter and interventional equipment.
- Device dimensions, crossing profile, and compatibility should be confirmed in the current manufacturer instructions for use; specifications may vary by model or generation.
- MRI safety should not be assumed from the 510(k) clearance. Check the current labeling for MR Safe, MR Conditional, or MR Unsafe status, and follow any conditions that apply.
- Risks may include coronary perforation or dissection, vessel injury, thrombosis, embolization, arrhythmia, myocardial infarction, bleeding, and the need for emergency surgery or additional intervention.
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.