FDA Denies Petition to Withdraw Approval of VenaSeal

FDA has rejected a citizen petition seeking to withdraw approval of Covidien’s VenaSeal vein-closure system, concluding the medical device remains safe, effective and appropriately regulated under existing law. In a detailed response, the agency said the petition failed to provide sufficient scientific or legal grounds to revoke the PMA for VenaSeal, which was originally approved in 2015 to treat chronic venous insufficiency by permanently sealing diseased veins in the legs.

A central claim in the petition, which was submitted by Olsson Frank Weeda, was that VenaSeal should be regulated as a drug rather than a device because it relies on chemical action. FDA disagreed, reaffirming that the product meets the statutory definition of a device.

The agency said VenaSeal works primarily through mechanical closure of veins, as its cyanoacrylate adhesive polymerizes and bonds vessel walls together. While chemical interactions occur, FDA determined they do not constitute the product’s primary mode of action. That distinction is critical under the Federal Food, Drug, and Cosmetic Act, which classifies products based on whether their primary intended purpose is achieved through chemical action or mechanical means.

FDA also pushed back on claims that the device lacked adequate evidence, pointing to three clinical studies submitted by the manufacturer, including the pivotal VeClose trial. According to the agency:

• The study met its primary endpoint, showing non-inferiority to standard treatment
• Approximately 99% of treated veins were successfully closed at three months
• No device-related serious adverse events, deep vein thrombosis, or pulmonary embolism were reported in the trial

Longer-term follow-up further supported durability, with vein closure rates of 97% at one year and 94% at three years, FDA said.

The petition also alleged inadequate preclinical testing and raised concerns about potential toxicity and cancer risk. FDA said the device underwent extensive laboratory, animal and biocompatibility testing consistent with internationally recognized ISO standards. While specific carcinogenicity studies were not conducted, the agency said a risk-based assessment of potential toxic byproducts found no need for additional testing under its current regulatory framework.

Additionally, FDA noted that concerns about adhesive migration or embolization—raised in the petition by referencing other products—were specifically evaluated in both preclinical and clinical studies, with no such safety signals detected.