RX Viatrac 14 Peripheral Dilatation Catheter OTW Viatrac 18 Peripheral Dilatation Catheter RX Herculink 14 Biliary Stn
Vascular Intervention
FDA Clearance Information
The RX Viatrac 14 and 18 Peripheral Dilatation Catheters and RX Herculink 14 Biliary Stent received FDA 510k clearance on June 13, 2001. Manufactured by Vascular Intervention, these devices are classified as Class 2 under product code DQY.
What It Is
FDA-Cleared Indications
- Percutaneous dilatation of stenotic or obstructed peripheral blood vessels.
- Use of a biliary stent to maintain patency of a narrowed or obstructed bile duct.
Clinical Applications
- Balloon angioplasty of narrowed peripheral arteries.
- Treatment of peripheral vascular stenosis when catheter-based dilatation is indicated.
- Placement of a biliary stent to support a narrowed bile duct.
- Relief of biliary obstruction caused by a ductal narrowing or other obstructive lesion when stenting is indicated.
Reported off-label uses
- Use of peripheral angioplasty balloons in selected venous stenoses may occur in clinical practice, but this is not necessarily covered by the device labeling.
- Use of biliary stents in clinical situations outside the labeled indication may occur under physician judgment; safety and effectiveness depend on the specific anatomy and condition.
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
- The Viatrac catheters are over-the-wire devices and require an appropriately sized guidewire, access sheath, and compatible delivery system.
- Catheter diameter and working length must match the target vessel, lesion, access route, and required balloon-to-vessel ratio.
- Use requires fluoroscopic imaging and contrast administration, with attention to vessel injury, dissection, perforation, embolization, and restenosis.
- MRI safety depends on the exact device model and any implanted biliary stent configuration; the current product labeling should be reviewed before MRI.
- Contraindications and precautions include inability to safely cross the lesion, significant bleeding risk, severe contrast reaction, uncontrolled infection, or anatomy incompatible with the device.
Frequently Asked Questions
What is RX Viatrac & Herculink used for?
These devices are used for dilating peripheral vessels and stenting biliary ducts to treat obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
They are indicated for peripheral vascular dilatation and biliary stenting to treat obstructions.