Last July I reported Venaseal was the subject of an FDA recall due to sterility issues in packaging. The recall was successful, and the manufacturer has resumed shipment to the few physicians performing this procedure.
As mentioned in our previous blogs, Venaseal is a patented catheter-based delivery system for treating the saphenous vein using “superglue.” Its major advantages over laser and radiofrequency thermal ablation are that it requires neither anesthesia nor compression stockings. Its major disadvantages are the lack of long-term outcome studies beyond one year, and a high cost which insurance companies do not yet cover, making it 100% out-of-pocket for the patient.
I have therefore chosen not to offer Venaseal until long-term studies prove it has durable success beyond one year, and insurance companies recognize Venaseal as a reimbursable procedure.