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novacross microcatheter
Nitiloop
Summary: The NovaCross microcatheter, manufactured by Nitiloop, is designed for facilitating the crossing of chronic total occlusions (CTOs) in coronary arteries. Key evidence supports its safety and efficacy in this application.
FDA Clearance Information
Pathway
510K
Number
K160389 ↗
Decision Date
March 11, 2016
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The NovaCross microcatheter received FDA 510(k) clearance on March 11, 2016. It is manufactured by Nitiloop and classified as a Class 2 device under product code DQY.
What It Is
The NovaCross microcatheter is a specialized device used to assist in the crossing of chronic total occlusions in coronary arteries. It is designed to enhance the delivery of guidewires through occluded vessels, improving procedural success rates.
Clinical Applications
This device is commonly used in interventional cardiology, particularly in procedures involving chronic total occlusions of coronary arteries. It is employed to facilitate guidewire passage in complex lesions.
Evidence Summary
The available literature includes seven studies, comprising randomized controlled trials and prospective studies, conducted between 2017 and 2021. These studies evaluate the safety and efficacy of the NovaCross microcatheter in clinical settings.
Reported Outcomes
Published studies report that the NovaCross microcatheter is effective in facilitating the crossing of chronic total occlusions, with improved procedural success rates. The device has demonstrated efficacy in both first-in-human and multicenter trials, supporting its use in complex coronary interventions.
Safety Profile
Reported complications include minor procedural complications typical of coronary interventions, with no significant adverse events directly attributed to the device. Overall, the safety profile is consistent with similar devices used in CTO procedures.
Evidence Limitations
Current evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to assess the long-term safety and efficacy of the NovaCross microcatheter in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for NovaCross microcatheter?
The NovaCross microcatheter is indicated for use in facilitating the crossing of chronic total occlusions in coronary arteries.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural success rates in crossing chronic total occlusions with the use of the NovaCross microcatheter.
What complications have been reported?
Reported complications include minor procedural issues typical of coronary interventions, with no significant adverse events directly linked to the device.
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.