FDA. US: The U.S. Food and Drug Administration today approved the VenaSeal
closure system (VenaSeal system) to permanently treat varicose veins of
the legs by sealing the affected superficial veins using an adhesive
agent.
There are two types of veins deep veins and superficial
veins. Superficial veins are those that are close to the skin. Veins
contain one-way valves that open to let blood flow through and then shut
to keep blood from flowing backward. When valves of the superficial
system are weak or damaged, blood can back up and pool, which can cause
varicose veins that are enlarged, swollen or twisted.
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
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.
“This new system is the first to permanently treat
varicose veins by sealing them with an adhesive, thereby giving patients
another treatment option for this common condition,” said William
Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation
in the FDA’s Center for Devices and Radiological Health. “Because the
VenaSeal system does not incorporate heat application or cutting, the
in-office procedure can allow patients to quickly return to their normal
activities, with less bruising.”
The FDA reviewed data for the
VenaSeal system in a premarket approval application, the agency’s
pathway to evaluate safety and effectiveness of Class III medical
devices. Data supporting the FDA approval included results from three
clinical studies sponsored by the manufacturer. The U.S. clinical study
assessed the safety and effectiveness of the VenaSeal system in 108
participants compared to radio-frequency ablation in 114 participants.
The trials showed the device to be safe and effective for vein closure
for the treatment of symptomatic superficial varicose veins of the legs.
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.
The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.