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excelsior 1018 and sl-10 microcatheters
Boston Scientific
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 510K
Number K042568 ↗
Decision Date October 15, 2004
Product Code DQY
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.
Clinical Applications
These microcatheters are commonly used in procedures such as mechanical thrombectomy, embolization, and the placement of stents or coils in the treatment of aneurysms or arteriovenous malformations. They are primarily utilized by interventional radiologists and neurosurgeons in hospital settings, particularly in the management of acute ischemic stroke and other cerebrovascular disorders. The devices are suitable for a wide range of patient populations requiring neurovascular intervention.
Indications for Use
The FDA-cleared indications suggest these microcatheters are intended for use in accessing the neurovasculature to deliver therapeutic devices or agents. They are particularly useful in conditions where precise navigation and placement within the cerebral vessels are required.
Practical Considerations
These microcatheters are available in various sizes to accommodate different vascular anatomies and procedural needs. They are compatible with a range of guidewires and other interventional tools, allowing for versatility in technique. Clinicians should be familiar with the specific handling and navigation techniques required for optimal performance.
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.