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FDA Approves Medtronic's Closure System To Permanently Treat Varicose Veins

In a recent article on RTTNews.com – it announces that The U.S. Food and Drug Administration said that it approved the VenaSeal closure system to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent. The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.

Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.
The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.
The FDA noted that the device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.
The FDA warned that the VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection. Adverse events observed in the trial and generally associated with treatments of this condition included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.
This News is brought to you courtesy of Dr. Bishara and The Paragon Plastic Surgery & Med Spa
 
 

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FDA OKs New Minimally Invasive Treatment for Varicose Veins

vericose veins
The US Food and Drug Administration (FDA) has approved polidocanol injectable foam (Varithena, BTG) for the treatment of incompetent veins and visible varicosities of the great saphenous vein (GSV) system, British pharmaceutical company BTG announced today.
Varithena (formerly known as Varisolve) is a pharmaceutical-grade, low-nitrogen, polidocanol foam dispensed from a proprietary canister device. It is a “minimally invasive, non-surgical procedure that requires neither tumescent anesthesia nor sedation,” the company said in a news release.
In a pair of phase 3 placebo-controlled studies known as VANISH-1 and VANISH-2, polidocanol injectable foam led to clinically meaningful improvement in the symptoms of superficial venous incompetence and the appearance of visible varicosities and addressed the underlying venous incompetence in the majority of patients treated, the company said.
It is estimated that more than 30 million adults in the United States have varicose veins, with women twice as likely as men to develop varicosities. Varicose veins may require treatment for symptoms including leg pain, aching, heaviness, restless legs, cramps, throbbing, fatigue, itchiness, tingling, and edema. Current treatments for varicose veins include thermal ablation and surgery.
Polidocanol injectable foam “provides US physicians with the only approved comprehensive therapy to improve symptoms and appearance for a wide range of varicose veins, including incompetent GSV, accessory saphenous veins and visible varicosities of the GSV system both above and below the knee,” BTG said.
According to the release, the company plans to launch the product in the second quarter of 2014.

This News is brought to you courtesy of Dr. Mark Bishara and The Paragon Plastic Surgery & Med Spa in Mansfield and Southlake

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