đź“‹ FDA Reference
Isleeve Introducer Set
Summary: The isleeve introducer set by Boston Scientific is a medical device used primarily in embolization procedures. It is typically utilized by interventional radiologists and cardiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202584 ↗
Decision Date ?
October 6, 2020
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The isleeve introducer set was cleared through the FDA 510(k) pathway on October 6, 2020. It is manufactured by Boston Scientific and classified as a Class 2 device under product code DYB.
What It Is
The isleeve introducer set is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is commonly used in minimally invasive procedures to provide a stable and secure access point. The device is engineered to minimize trauma to the vessel and ensure smooth passage of instruments.
FDA-Cleared Indications
- Provides vascular access for the introduction of catheters and other intravascular devices during diagnostic or therapeutic procedures.
- Facilitates delivery of embolization coils and other embolic devices when vascular access is required.
Clinical Applications
- Establishing vascular access for catheter-based procedures
- Providing access during embolization procedures
- Supporting delivery of embolization coils or other embolic devices
- Access for diagnostic vascular interventions
Practical Considerations
- The set is available in different sizes; the selected size should match the access vessel, catheter, and intended procedure.
- Compatibility with the planned catheter, guidewire, coil, embolic agent delivery system, and other equipment should be confirmed before use.
- Insertion and removal require sterile technique and appropriate vascular-access skills, with imaging guidance commonly used to reduce complications.
- Potential access-site complications include bleeding, hematoma, infection, vessel injury, thrombosis, and embolization.
- MRI safety depends on the specific device materials and labeling. Confirm the current manufacturer instructions for use and MRI conditions before scanning; do not assume the device is 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. While the abstract is not available, the study likely investigates the efficacy and safety of the valve system. Limitations may include the lack of long-term outcome data and specific patient population details.
Procedures that use this device
Frequently Asked Questions
What is isleeve introducer set used for?
The isleeve introducer set is used for vascular access in procedures like embolization, facilitating the introduction of catheters and other devices.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use the isleeve introducer set in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in vascular access procedures, particularly in embolization, to assist in the delivery of embolization coils and other devices.
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.