đź“‹ FDA Reference
Venacure Evlt Nevertouch Direct Introducer Sheath
Summary: The Venacure EVLT NeverTouch Direct Introducer Sheath is a medical device used in endovenous laser therapy for varicose veins. It is typically used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K170695 ↗
Decision Date ?
May 30, 2017
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Venacure EVLT NeverTouch Direct Introducer Sheath was cleared via the FDA 510k pathway on May 30, 2017. It is manufactured by Angiodynamics and classified as a Class 2 device.
What It Is
The Venacure EVLT NeverTouch Direct Introducer Sheath is designed for use in endovenous laser therapy, a minimally invasive procedure to treat varicose veins. The sheath allows for the precise introduction of laser fibers into the vein, ensuring effective energy delivery. Its design minimizes the risk of thermal damage to surrounding tissues, enhancing patient safety.
FDA-Cleared Indications
- Use as an introducer sheath for endovenous laser therapy of incompetent veins.
- Use during treatment of superficial venous reflux associated with varicose veins.
Clinical Applications
- Percutaneous access and positioning of a laser fiber within a refluxing superficial vein.
- Endovenous laser treatment of saphenous vein reflux.
- Endovenous treatment of varicose veins caused by venous insufficiency.
Practical Considerations
- The appropriate sheath size and length depend on the target vein, access site, patient anatomy and compatible laser-fiber system.
- The sheath is generally inserted under ultrasound guidance, commonly through percutaneous access in the lower extremity.
- Clinicians should confirm compatibility with the selected laser fiber and follow the device instructions for use.
- Careful positioning and controlled laser delivery are important to reduce the risk of venous perforation, bleeding, thrombosis or thermal injury to surrounding tissue.
- MRI safety and conditional use should be verified in the current manufacturer labeling; do not assume the device is MRI safe based only on its name or FDA clearance.
Frequently Asked Questions
What is the Venacure EVLT NeverTouch Direct Introducer Sheath used for?
It is used in endovenous laser therapy to treat varicose veins by facilitating the introduction of laser fibers into the vein.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
The device is indicated for use in endovenous laser therapy for patients with varicose veins, particularly those with saphenous vein reflux.
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.