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venacure evlt nevertouch direct introducer sheath
Angiodynamics
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
510K
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.
Clinical Applications
This device is commonly used in the treatment of varicose veins, particularly in patients with chronic venous insufficiency. It is utilized in outpatient settings by vascular surgeons and interventional radiologists. The sheath facilitates procedures that aim to close off incompetent veins, improving venous circulation and reducing symptoms such as pain and swelling.
Indications for Use
The FDA indications for this device include its use in endovenous laser therapy for patients with varicose veins. It is particularly indicated for those with saphenous vein reflux, a common cause of varicose veins.
Practical Considerations
The sheath is available in various sizes to accommodate different vein diameters and patient anatomies. It is compatible with standard laser fibers used in endovenous procedures. Clinicians should ensure proper technique to avoid complications such as vein perforation or thermal injury.
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.