What makes the VenaSealTM procedure comfortable?
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*The VenaSealTM closure system offers freedom from tumescent anesthesia, thermal nerve injury and post-procedure compression stockings†.
Low Intraprocedural Pain
In the VeClose trial, VenaSealTM system patients reported low intraprocedural pain scores on a 0-10 point scale1.
Subjects treated with the VenaSealTM system had less ecchymosis at day 3 than those treated with traditional RFA1.
Quick Return to Work
Subjects treated with the VenaSealTM system had a quick return to work2,3,4.
Proportion of limbs free from varicose veins increased with time from 0% at baseline to 47% at month 65.
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US Safety Information:
Intended Use/Indications: 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).
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 exists.
Potential Adverse Effects of the Device on Health: Below is a list of the potential adverse effects (e.g., complications) associated with the use of the VenaSeal system. The adverse events associated with the device are similar to those with traditional endovenous thermal ablation procedures. In addition, there are several risks unique to the VenaSeal system due to its material and product design as an implant. These potential adverse events include, but are not limited to, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock, arteriovenous fistula, bleeding from the site of access, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, infection at the access site, non-specific mild inflammation of the cutaneous and subcutaneous tissue, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria or ulceration may occur at the site of injection, vascular rupture and perforation, and visible scarring.
IMPORTANT: Warnings, precautions, and instructions for use can be found in the product labeling. For U.S. product, the labeling can be found here.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.