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Excelsior 1018 and Sl-10 Microcatheters
Summary: The Excelsior 1018 and SL-10 microcatheters are used in neurovascular procedures, primarily by interventional radiologists and neurosurgeons, to access and treat vascular conditions in the brain.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K042568 ↗
Decision Date ?
October 15, 2004
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Excelsior 1018 and SL-10 microcatheters were cleared via the FDA 510(k) pathway on October 15, 2004, by Boston Scientific. They are classified as Class II devices under product code DQY.
What It Is
The Excelsior 1018 and SL-10 are microcatheters designed for neurovascular interventions. These devices facilitate the delivery of therapeutic agents or devices to specific sites within the cerebral vasculature. Their design allows for navigation through the complex and delicate network of blood vessels in the brain, providing clinicians with the ability to perform minimally invasive procedures with precision.
FDA-Cleared Indications
- Access the neurovasculature for the selective delivery of therapeutic agents.
- Access the neurovasculature for the delivery and placement of therapeutic devices.
- Provide catheter access to cerebral vessels during neurovascular interventional procedures.
Clinical Applications
- Selective catheterization of cerebral arteries during neurovascular intervention.
- Delivery of embolic agents to targeted intracranial blood vessels when indicated.
- Delivery and placement of therapeutic devices used in the cerebral vasculature.
- Navigation through tortuous neurovascular anatomy to reach a treatment site.
Reported off-label uses
- Use as an adjunctive microcatheter during endovascular treatment of intracranial aneurysms, arteriovenous malformations, or dural arteriovenous fistulas when the specific application is not stated in the device labeling.
- Use during endovascular stroke procedures as an access or delivery catheter in configurations not specifically described in the 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 1018 and SL-10 models have different design and size characteristics; the selected catheter should match the target vessel, anatomy, guidewire, and intended therapy.
- Use compatible guidewires, delivery systems, and therapeutic agents according to the device instructions for use and the requirements of the planned procedure.
- Navigation requires fluoroscopic or other appropriate imaging guidance and careful manipulation because cerebral vessels are small and fragile.
- Contraindications and warnings include inability to safely catheterize the target vessel, significant vascular spasm or dissection risk, and known incompatibility with the intended agent or device.
- MRI safety depends on the specific catheter configuration and whether it remains in the patient; consult the current labeling for MR conditions before scanning.
Related Literature
The linked study explored the use of the Penumbra Stroke System in a novel posterior-to-anterior circulation approach for mechanical thrombectomy in a right middle cerebral artery thrombus. The study highlighted the feasibility of this approach, demonstrating successful access and treatment of the thrombus. However, the study was limited by its single-case nature, and further research would be needed to generalize the findings.
Frequently Asked Questions
What is Excelsior 1018 and SL-10 used for?
These microcatheters are used for accessing the neurovasculature to deliver therapeutic agents or devices, often in the treatment of conditions like stroke or aneurysms.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use these devices in neurovascular procedures.
What are the FDA-cleared indications?
The devices are indicated for accessing the neurovasculature to deliver therapeutic agents or devices, particularly in conditions requiring precise navigation within cerebral vessels.
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.