Vessix Guide Sheath 7f 45 Cm Rdc Vessix Guide Sheath 7f 45cm Lima
Contact Boston Scientific Corporation ↗ Compare similar devices
FDA Clearance Information
The Vessix Guide Sheath 7F 45cm, manufactured by Boston Scientific, was cleared through the FDA 510(k) pathway on July 3, 2014. It is a Class 2 device under the product code DYB.
What It Is
FDA-Cleared Indications
- Provides access for the introduction and delivery of embolization coils and other interventional devices during vascular procedures.
Clinical Applications
- Delivery of embolization coils during endovascular treatment of selected vascular lesions.
- Providing catheter and device support during procedures that require controlled access to a blood vessel.
- Use in minimally invasive embolization procedures performed by advancing devices through the vascular system under fluoroscopic imaging.
Reported off-label uses
- Clinicians may use guide sheaths of this type to support delivery of other compatible embolic or endovascular devices when the combination is appropriate and permitted by institutional practice. Such use may be outside the device labeling and should not be undertaken without reviewing compatibility, instructions for use, and clinical judgment.
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
- This model is 7 French (7F) and 45 cm long; the catalog name also includes an RDC/LIMA configuration designation.
- Confirm that the sheath's inner diameter, length, curve, and compatibility specifications match the selected catheter, coil, embolic agent, or other device.
- Insertion and advancement are performed over a guidewire under fluoroscopic or other appropriate imaging guidance by trained clinicians.
- Potential complications of vascular sheath placement include bleeding, hematoma, vessel injury, thrombosis, infection, embolization, and contrast-related complications.
- MRI safety and conditional-use details should be verified in the current Boston Scientific labeling; do not assume the sheath is safe in an MRI environment merely because it is nonferromagnetic or has no active electronic components.
Procedures that use this device
Frequently Asked Questions
What is the Vessix Guide Sheath 7F 45cm used for?
It is used to facilitate the delivery of embolization coils and other interventional devices into the vascular system during minimally invasive procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists typically use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the delivery of embolization coils, such as in the treatment of aneurysms or vascular abnormalities.