📋 FDA Reference
Isleeve Introducer Set
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Summary: The isleeve introducer set is a medical device used for vascular access during embolization procedures. It is primarily used by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K180785 ↗
Decision Date ?
June 22, 2018
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The isleeve introducer set was cleared through the FDA 510(k) pathway on June 22, 2018. It is manufactured by Boston Scientific and classified as a Class 2 device.
What It Is
The isleeve introducer set is a vascular access device designed to facilitate the insertion of catheters and other instruments into the vascular system. It typically consists of a sheath and dilator, allowing for smooth entry into blood vessels. This device is crucial in procedures requiring precise and stable vascular access, such as embolization.
FDA-Cleared Indications
- Provides vascular access for the introduction of catheters and other intravascular devices during endovascular procedures.
- Supports access and device delivery during procedures such as embolization, when compatible with the selected catheter and embolic device.
Clinical Applications
- Obtaining vascular access for catheter-based embolization procedures.
- Providing a sheath-and-dilator pathway for delivery of embolization coils or other compatible embolic devices.
- Maintaining access during diagnostic or therapeutic endovascular procedures requiring catheter and device exchange.
Practical Considerations
- Available sizes and configurations should be selected according to the target vessel, access site, catheter diameter and procedural requirements.
- The set generally includes an introducer sheath and dilator; the sheath is placed over a guidewire using standard percutaneous vascular-access technique.
- Compatibility with the intended catheter, guidewire and embolization device must be confirmed before use.
- Insertion and removal can cause bleeding, hematoma, vessel injury, thrombosis or infection; appropriate access-site management is required.
- MRI safety depends on the specific components and whether they remain in the patient. The applicable product labeling should be checked before MRI; a removed or temporary introducer set should not be assumed to be MRI safe.
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 repositionable valve system in aortic valve replacement. Although specific findings are not available, the study likely investigates procedural outcomes and device efficacy. Limitations include the lack of an abstract and detailed results.
Procedures that use this device
Frequently Asked Questions
What is the isleeve introducer set used for?
It is used for vascular access in procedures like embolization, allowing for the insertion of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for vascular access in patients undergoing procedures such as embolization.
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.