đź“Š Evidence-Based Reference
Novacross Microcatheter
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 ?
510(k)
Number ?
K143608 ↗
Decision Date ?
May 4, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter intended for use in vascular procedures.
- Use must follow the complete manufacturer labeling and the cleared indication associated with FDA 510(k) K143608.
Clinical Applications
- Percutaneous vascular procedures requiring catheter delivery through the vasculature.
- Catheter-based treatment of selected peripheral vascular lesions when used according to the device labeling.
- Catheter-based treatment of selected coronary lesions when used according to the device labeling.
Reported off-label uses
- Crossing chronic total occlusions in coronary arteries.
- Crossing chronic total occlusions in peripheral arteries, including femoropopliteal vessels.
- Supporting guidewire exchange or enhanced guidewire support during complex endovascular procedures.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- Confirm the catheter diameter, working length, guidewire compatibility and minimum guiding-catheter or sheath size before use.
- Use fluoroscopic or other appropriate imaging guidance and follow the manufacturer's instructions for preparation, advancement and wire manipulation.
- Do not force the catheter or guidewire across resistance; vessel injury, dissection or perforation can occur.
- MRI safety and conditional-use information should be verified in the current manufacturer labeling; this record does not establish that the device is MR safe.
- The device is intended for single-use procedures unless the current labeling states otherwise; resterilization or reuse may create infection or device-performance risks.
Procedures that use this device
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.