What makes the VenaSealTM procedure comfortable?

Contact Us to learn more about the VenaSeal™ closure system.

*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.

Less Ecchymosis

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.

Visible Varicosities

Proportion of limbs free from varicose veins increased with time from 0% at baseline to 47% at month 65.

Questions?  Contact Us to learn more about the VenaSeal™ closure system.

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.

FTSOP113326-36 Rev. 1A

*Tumescent anesthesia, thermal nerve injury, post-procedure compression stockings.

†Some patients may benefit from the use of compression stockings post-procedure.

‡Results are from different clinical studies and do not represent a head-to-head comparison of the affected devices; results may differ in a head-to-head comparison. Chart is for illustration purposes only.

References:

  1. Morrison, N., et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). Journal or Vascular Surgery 2015; 61: 985-994.
  2. Rasmussen, L.H., et al. Randomized clinical trial comparing endovenous laser ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. British Journal of Surgery 2011; 98: 1079-1087.
  3. Gibson K. Cyanoacrylate Closure of Incompetent Great, Small and Accessory Saphenous Veins without the use of Post-Procedure Compression: A Post-Market Evaluation of the VenaSeal System (WAVES trial): Twelve Month Data. Results presented at: Charing Cross; 2017; London, UK.
  4. Gibson, K, and Ferris, B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: Initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study).Vascular (2016) May 20, Epub 2016 May,1708538116651014.
  5. Almeida Jl, Javier JJ, Mackay EG, Bautista C, Cher DJ, Proebstle TM. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. Journal of Vascular Surgery: Venous and Lymphatic Disorders 2017.

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