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novacross microcatheter
Nitiloop
Summary: The NovaCross microcatheter by Nitiloop is designed for crossing chronic total occlusions (CTOs) in coronary and peripheral arteries. Key studies highlight its safety and efficacy in facilitating CTO procedures.
FDA Clearance Information
Pathway
510K
Number
K143608 ↗
Decision Date
May 4, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The NovaCross microcatheter received FDA clearance through the 510(k) pathway on May 4, 2015. It is manufactured by Nitiloop and classified as a Class 2 device.
What It Is
The NovaCross microcatheter is a specialized device used to assist in crossing chronic total occlusions in coronary and peripheral arteries. It is designed to enhance guidewire support and facilitate lesion crossing in complex vascular interventions.
Clinical Applications
The NovaCross microcatheter is commonly used in interventional cardiology and radiology for patients with chronic total occlusions, particularly in coronary and femoropopliteal arteries. It aids in complex percutaneous coronary interventions (PCI) and peripheral vascular procedures.
Evidence Summary
The available literature includes seven studies, comprising randomized controlled trials and prospective studies, evaluating the NovaCross microcatheter. These studies span from 2017 to 2021, focusing on its safety and efficacy in CTO procedures.
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 shown promise in enhancing guidewire support and lesion crossing capabilities in complex cases.
Safety Profile
Reported complications include minor procedural adverse events, which are consistent with those typically observed in CTO interventions. Overall, the device has demonstrated a favorable safety profile in the evaluated studies.
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 establish the long-term efficacy and safety 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 crossing chronic total occlusions in coronary and peripheral arteries, particularly in complex interventional procedures.
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 using the NovaCross microcatheter.
What complications have been reported?
Safety data from evidence indicate minor procedural adverse events, with an overall favorable safety profile for the NovaCross microcatheter.
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.