đź“Š Evidence-Based Reference
Novacross CTO Microcatheter
Summary: The NovaCross CTO Microcatheter by Nitiloop is designed for crossing chronic total occlusions in coronary arteries. It is FDA 510(k) cleared and supported by multiple studies demonstrating its efficacy and safety in facilitating coronary interventions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K193322 ↗
Decision Date ?
April 2, 2020
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The NovaCross CTO Microcatheter received FDA 510(k) clearance on April 2, 2020. Manufactured by Nitiloop, it is classified as a Class 2 medical device under product code DQY.
What It Is
The NovaCross CTO Microcatheter is a specialized device used in interventional cardiology to facilitate the crossing of chronic total occlusions (CTOs) 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 interventions involving coronary arteries.
- Used to facilitate guidewire navigation and support during catheter-based treatment of complex coronary lesions.
- Intended for use by trained medical professionals in patients who require coronary catheter-based intervention.
Clinical Applications
- Guidewire support during coronary chronic total occlusion interventions.
- Navigation through difficult or complex coronary artery lesions during PCI.
- Catheter exchange or advancement support during selected coronary interventions.
- Facilitation of guidewire placement before balloon angioplasty or coronary stent treatment.
Evidence Summary
The available literature includes seven studies, comprising randomized controlled trials and prospective studies, evaluating the NovaCross CTO Microcatheter. These studies span from 2017 to 2021, providing a comprehensive overview of its clinical performance.
Reported Outcomes
Published studies report that the NovaCross CTO Microcatheter effectively facilitates the crossing of coronary CTOs, improving procedural success rates. The device has shown promising results in enhancing guidewire support and reducing procedure time 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 of the NovaCross CTO Microcatheter is consistent with other devices in its class.
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 safety and efficacy of the NovaCross CTO Microcatheter in diverse patient populations.
Practical Considerations
- The specific catheter diameter, working length, tip configuration and guidewire compatibility depend on the selected model; users should follow the current manufacturer’s instructions for use.
- The device is intended for coronary catheter procedures and requires compatible guiding catheters, guidewires and imaging equipment.
- Use requires fluoroscopic guidance and trained interventional cardiology personnel.
- MRI safety should be confirmed in the current device labeling; do not assume that a catheter left in the body is MRI safe.
- Potential risks include vessel injury, dissection, perforation, spasm, thrombosis, bleeding, infection and complications related to the coronary intervention itself.
Frequently Asked Questions
What are the clinical indications for NovaCross CTO Microcatheter?
The NovaCross CTO Microcatheter is indicated for use in patients with coronary chronic total occlusions to facilitate guidewire crossing and improve procedural success in percutaneous coronary interventions.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved success rates in crossing coronary CTOs, enhanced guidewire support, and reduced procedure times when using the NovaCross CTO Microcatheter.
What complications have been reported?
Safety data from evidence indicate minor procedural complications typical of coronary interventions, with no significant adverse events directly linked to the NovaCross CTO 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.