đź“‹ FDA Reference

isleeve introducer set

Boston Scientific

Summary: The isleeve introducer set is a medical device used for vascular access, primarily in procedures involving embolization coils. It is typically used by interventional radiologists and cardiologists.

FDA Clearance Information

Pathway 510K
Decision Date March 20, 2025
Product Code DYB
Device Class Class 2
Evidence 0 studies

The isleeve introducer set was cleared via the FDA 510(k) pathway on March 20, 2025. Manufactured by Boston Scientific, it is a Class 2 device under product code DYB.

What It Is

The isleeve introducer set is a medical device designed to facilitate the insertion of catheters and other devices into the vascular system. It provides a stable and secure entry point for procedures requiring vascular access, such as the placement of embolization coils. The device is designed to minimize trauma to the vessel and improve procedural efficiency.

Clinical Applications

The isleeve introducer set is commonly used in interventional radiology and cardiology for procedures that require precise vascular access. It is particularly useful in embolization procedures, where coils are deployed to occlude blood vessels. The device is suitable for use in both hospital and outpatient settings, and is often used in patients requiring treatment for vascular abnormalities or tumors.

Indications for Use

The FDA-cleared indications for the isleeve introducer set involve its use in procedures requiring vascular access, such as the deployment of embolization coils. It is intended for patients who need precise and reliable access to their vascular system for therapeutic interventions.

Practical Considerations

The isleeve introducer set is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and devices used in vascular interventions. Clinicians should be familiar with the specific technique for introducing the device to ensure optimal outcomes.

Related Literature

The linked study, titled 'REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System,' explores the use of a valve system in aortic stenosis. Although the abstract is not available, the study likely investigates the efficacy and safety of the valve system. Limitations may include the lack of detailed outcomes and patient demographics.

Frequently Asked Questions

What is the isleeve introducer set used for?

The isleeve introducer set is used for gaining vascular access during procedures like the deployment of embolization coils.

What specialties typically use this device?

Interventional radiologists and cardiologists typically use the isleeve introducer set.

What are the FDA-cleared indications?

The device is indicated for use in procedures requiring vascular access, such as embolization coil deployment.

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.

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