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Stride Microcatheter
Summary: The Stride Microcatheter is a medical device used for precise delivery of embolic agents in therapeutic embolotherapy. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K062885 ↗
Decision Date ?
June 13, 2007
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Stride Microcatheter by Asahi Intecc was cleared through the FDA 510k pathway on June 13, 2007. It is classified as a Class 2 device under product code DQY.
What It Is
The Stride Microcatheter is a specialized catheter designed for the delivery of embolic agents to occlude blood vessels. It is used in procedures requiring high precision, such as embolotherapy, where it helps block blood flow to specific areas, often in the treatment of tumors or arteriovenous malformations. Its design allows for navigation through small and tortuous vessels, making it ideal for accessing hard-to-reach areas.
FDA-Cleared Indications
- Use in embolotherapy to deliver embolic agents for the occlusion of blood vessels.
- Use for selective catheterization and treatment of vessels when targeted blood-flow reduction or vessel occlusion is required.
Clinical Applications
- Selective delivery of embolic agents during therapeutic embolization.
- Occlusion of selected blood vessels supplying hypervascular tumors when embolotherapy is indicated.
- Occlusion of selected vessels associated with vascular malformations when embolotherapy is indicated.
- Embolization procedures performed by interventional specialists using image-guided percutaneous catheterization.
Reported off-label uses
- Delivery of embolic agents for selected gastrointestinal bleeding procedures.
- Embolization of uterine arteries for symptomatic uterine fibroids.
- Embolization of selected bleeding vessels after trauma or surgery.
- Delivery of embolic agents in other vascular territories when the use is outside the device's specific FDA labeling.
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.
Practical Considerations
- The device is available in different catheter sizes and configurations; the appropriate selection depends on vessel diameter, access route, embolic agent, and the anatomy being treated.
- It is used through percutaneous vascular access with fluoroscopic or other appropriate imaging guidance by clinicians trained in catheterization and embolization.
- Compatibility with an embolic agent, guidewire, and other procedural equipment should be confirmed in the current manufacturer instructions for use before use.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is safe for MRI based only on its catheter classification.
- Contraindications, warnings, and handling requirements are specified in the current instructions for use. Potential procedural concerns include vascular injury, non-target embolization, bleeding, infection, and contrast-related complications.
Related Literature
The linked study reviews methods for characterizing microspheres used in embolotherapy, highlighting the importance of precise delivery systems like microcatheters. It discusses the transition from animal models to more refined methods, emphasizing the role of microcatheters in delivering embolic particles to small vessels. Limitations include the need for further research on human applications and long-term outcomes.
Frequently Asked Questions
What is the Stride Microcatheter used for?
The Stride Microcatheter is used for delivering embolic agents to occlude blood vessels in procedures like embolotherapy.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Stride Microcatheter.
What are the FDA-cleared indications?
The Stride Microcatheter is indicated for use in embolotherapy to occlude blood vessels in patients with conditions like tumors or vascular malformations.
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.