Device Treatment for Varicose Veins Got Approval From US FDA
The U.S. Food and Drug Administration has accepted the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by closing the damaged superficial veins applying an adhesive agent.
There are two kinds of veins they are
- Deep veins and
- Superficial veins
Superficial veins are those that are near to the skin. Veins consist of one-way valves that open to allow blood flow through and then shut to keep blood from moving backward. When valves of the superficial system are weak or destroyed, blood can back up and pool, which can lead to varicose veins that are enlarged, inflamed or twisted.
Varicose veins usually lead to no symptoms but some sufferers may experience mild to moderate pain, blood clots, skin ulcers or other issues, with respect to the National Institutes of Health. If these problems occur, health care specialists may suggest therapy like as compression stockings or medical processes to eliminate or close the damaged veins.
The VenaSeal system is designed for sufferers with superficial varicose veins of the legs that lead to symptoms. The sterile kit is made up of an adhesive, a exclusively developed n-butyl-2-cyanoacrylate, and delivery system elements that consist of a catheter, dispenser tips, dispenser gun, syringes and guidewire .
The device should be applied as a system and is different from methods that used in medication, radio waves, laser or cuts in the skin to close or take out veins. A trained healthcare expert inserts the catheter via the skin into the infected vein to enable injection of the VenaSeal adhesive, a clear fluid that polymerizes into solid substance. The healthcare expert monitors appropriate placement of the catheter using ultrasound imaging while in delivery of the adhesive into the infected vein to seal it.
William Maisel, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health stated
“This new system is the initial to completely treat varicose veins by closing them with an adhesive, and thus giving sufferers another therapy option for this common problem.” Because the VenaSeal system doesn’t integrate heat application or cutting, the in-office process can allow sufferers to easily come back to their normal activities, with less bruising.
The FDA analyzed data for the VenaSeal system in a premarket approval application, the agency’s process to examine safety and effectiveness of Class III medical devices. Clinical Data supporting the FDA acceptance included outcomes from three clinical studies backed by the manufacturer. The U.S. clinical study evaluated the safety and effectiveness of the VenaSeal system in 108 individuals in comparison to radio-frequency ablation in 114 individuals. The studies confirmed the device to be safe and successful for vein closure for the therapy of symptomatic superficial varicose veins of the legs.
The VenaSeal system must not be applied in sufferers who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins because of blood clots or extreme whole-body infection. Adverse events noticed in the study and usually associated with treatments of this problem – included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment area.