đź“Š Evidence-Based Reference
Novacross Microcatheter
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 ?
510(k)
Number ?
K172297 ↗
Decision Date ?
October 18, 2017
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used in percutaneous coronary procedures to facilitate guidewire placement across coronary artery lesions.
- Intended for use in the coronary vasculature by trained interventional cardiology professionals.
- The device is a Class II percutaneous catheter cleared through the FDA 510(k) pathway under product code DQY.
Clinical Applications
- Supporting guidewire crossing during complex coronary artery interventions.
- Facilitating treatment of coronary chronic total occlusions when standard guidewire techniques are insufficient.
- Providing catheter support and controlled access during fluoroscopy-guided percutaneous coronary intervention.
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.
Practical Considerations
- Use only with compatible guidewires, guiding catheters and accessory equipment specified in the device labeling.
- The catheter is advanced through the vascular system under fluoroscopic imaging; avoid forceful advancement if resistance is encountered.
- Access is typically obtained through the radial or femoral artery, with local anesthesia and sedation as needed for the coronary procedure.
- MRI safety status, including whether the device is MR Safe, MR Conditional or MR Unsafe, should be confirmed in the current manufacturer labeling; a catheter left in the body should not be assumed to be MRI safe.
- Potential complications relate to catheterization and coronary intervention and may include vessel injury, dissection, perforation, bleeding, thrombosis, infection, arrhythmia or contrast-related reactions.
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.