Manufacturer > Medtronic > Devices > VENASEAL CLOSURE SYSTEM

VENASEAL CLOSURE SYSTEM

Device-Type

Ablation System

Manufacturer

Medtronic

NONTHERMAL VEIN CLOSURE

The VenaSeal system delivers a small amount of a specially formulated medical adhesive to seal — or close — the diseased vein, rerouting blood to nearby healthy veins, which provides symptom relief.

A MORE COMFORTABLE EXPERIENCE

  • Simple outpatient procedure
  • No tumescent anesthesia
  • Less pain and bruising than thermal ablation
  • Faster recovery time than thermal ablation
  • Compression stockings not needed after the procedure


The VenaSeal closure system (VenaSeal system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).


HOW VENASEAL CLOSURE SYSTEM WORKS


Illustration of adhesive being placed in the vein via small catheter


Step 1: Adhesive Placed

Adhesive is placed in the vein via small catheter.


Clinician's hand compressing a vein after a drop of VenaSeal adhesive has been inserted


Step 2: Pressure Applied

Pressure is applied to the leg to help seal the vein.


Illustration of small catheter being removed from the vein after a VenaSeal procedure


Step 3: Catheter Removed

The small catheter is removed from the vein.


Illustration of bandage applied over the access site after a VenaSeal procedure



Step 4: Bandage Applied

A bandage is applied to cover the access site.


Safety informations

CONTRAINDICATIONS

Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis.

Potential adverse events

The potential adverse effects (e.g., complications) associated with the use of the VenaSeal system include, but are not limited to, adverse reactions to a foreign body (including, but not limited to, nonspecific mild inflammation of the cutaneous and subcutaneous tissue), arteriovenous fistula, bleeding from the access site, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, hypersensitivity or allergic reactions to cyanoacrylates, such as urticaria, shortness of breath, and anaphylactic shock, infection at the access site, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria, erythema, or ulceration may occur at the injection site, vascular rupture and perforation, visible scarring.

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