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Cerusendo Microcatheter
Cerus Endovascular
Summary: The Cerusendo Microcatheter is a device used in endovascular procedures, primarily for navigating complex vascular anatomy. Key evidence highlights its role in enhancing procedural success in challenging cases.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182487 ↗
Decision Date ?
July 20, 2019
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Cerusendo Microcatheter was cleared by the FDA through the 510k pathway on July 20, 2019. It is manufactured by Cerus Endovascular and classified as a Class 2 device.
What It Is
The Cerusendo Microcatheter is designed for use in endovascular procedures, facilitating the navigation and delivery of therapeutic agents or devices within the vascular system. It is intended for use in complex vascular anatomies.
FDA-Cleared Indications
- Percutaneous intravascular access and navigation during endovascular procedures.
- Delivery of therapeutic agents or devices within the vascular system when used with compatible equipment.
- Use in accordance with the specific device labeling, including its stated size, compatibility, and intended vascular application.
Clinical Applications
- Selective catheterization of blood vessels during image-guided endovascular procedures.
- Delivery of compatible embolic materials or other therapeutic agents.
- Delivery of compatible interventional devices through a catheter system.
- Navigation through complex or tortuous vascular anatomy when clinically appropriate.
Evidence Summary
The literature includes 10 studies, comprising case series and expert consensus reports, published between 2023. These studies explore the device's application in complex vascular interventions.
Reported Outcomes
Published studies report that the Cerusendo Microcatheter enhances procedural success in navigating complex vascular anatomies, particularly in cases with challenging angulations. It facilitates accurate device placement and reduces procedural complications.
Safety Profile
Reported complications include risks associated with microcatheter entrapment and procedural challenges in highly angulated lesions. However, innovative techniques have been developed to mitigate these risks.
Evidence Limitations
The evidence is limited by the small number of studies and the predominance of case series, which may not provide comprehensive efficacy and safety data. Further research is needed to establish long-term outcomes and broader clinical applicability.
Practical Considerations
- The available sizes, lengths, distal-tip configuration, and other specifications should be checked in the current manufacturer’s instructions for use.
- Use requires compatible guidewires, introducers, diagnostic catheters, and therapeutic devices; compatibility should be confirmed before the procedure.
- The catheter is generally handled under fluoroscopic or other appropriate imaging guidance by trained personnel.
- MRI safety depends on the specific device configuration and labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status before MRI.
- Potential complications are those associated with intravascular catheterization, including vessel injury, dissection, perforation, thrombosis, embolization, bleeding, infection, and contrast-related reactions.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Cerusendo Microcatheter?
The Cerusendo Microcatheter is indicated for use in endovascular procedures requiring navigation through complex vascular anatomies.
What outcomes have been reported in clinical studies?
Studies report enhanced procedural success and accurate device placement in complex vascular interventions.
What complications have been reported?
Complications include microcatheter entrapment and procedural challenges, particularly in highly angulated lesions.
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.