đź“Š Evidence-Based Reference
novacross microcatheter
Nitiloop
Summary: The NovaCross microcatheter by Nitiloop is designed for crossing chronic total occlusions (CTOs) in coronary arteries. Key evidence highlights its efficacy in facilitating CTO procedures with a focus on safety.
FDA Clearance Information
Pathway
510K
Number
K172297 ↗
Decision Date
October 18, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The NovaCross microcatheter received FDA clearance through the 510(k) pathway on October 18, 2017. Manufactured by Nitiloop, it is classified as a Class 2 device.
What It Is
The NovaCross microcatheter is a specialized device used to facilitate the crossing of chronic total occlusions in coronary arteries. It is designed to enhance guidewire support and improve procedural success in complex coronary interventions.
Clinical Applications
The device is commonly used in interventional cardiology for patients with ischemic heart disease due to coronary chronic total occlusions. It is particularly useful in cases where traditional guidewire techniques are insufficient.
Evidence Summary
The 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 enhancing guidewire support during complex coronary interventions.
Safety Profile
Reported complications include minor procedural adverse events, with no significant safety concerns identified in the reviewed studies. The device is generally well-tolerated in clinical use.
Evidence Limitations
The evidence is limited by the small sample sizes and the lack of long-term follow-up data. Further research is needed to confirm the long-term safety and effectiveness of the device 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 and enhanced guidewire support in crossing chronic total occlusions.
What complications have been reported?
Reported complications include minor procedural adverse events, with no significant safety concerns identified.
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.