I saw on-line a discussion about a new spider vein treatment called Asclera. Can a medical doctor here please explain what this is...is it a drug? Is it like sclerotherapy? do you still get the shadowing side effect from treated veins on legs?
What is Asclera for Veins?
Doctor Answers (7)
Asclera is Polidochanol which has been FDA cleared - Buffalo Niagara Asclera Sclerotherapy
Here is the verbatim press release from the US FDA:
The U.S. Food and Drug Administration today approved Asclera (polidocanol) injection for the treatment of small types of abnormally swollen or twisted veins called varicose veins. Although they usually occur in the legs, varicose veins also can form in other parts of the body. Factors such as genetics, age, female gender, pregnancy, obesity, and prolonged periods of standing may increase the risk for varicose veins.“Varicose veins are a common condition,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products at the FDA’s Center for Drug Evaluation and Research. “Asclera is indicated for the treatment of small types of varicose veins when the aim of treatment is to improve appearance.” Asclera is approved to close spider veins (tiny varicose veins less than 1 millimeter in diameter) and reticular veins (those that are 1 to 3 millimeters in diameter). Asclera acts by damaging the cell lining of blood vessels. This causes the blood vessel to close, and it is eventually replaced by other types of tissue. Common adverse reactions to Asclera include leakage and collection of blood from damaged blood vessels at the injection site (hematoma), bruising, irritation, discoloration, and pain at the injection site.
Asclera is distributed by BioForm Medical Inc. of Franksville, Wis., and manufactured by Chemische Fabrik Kreussler & Co. of Wiesbaden, Germany.
This is a drug for injecting into venous tissue, like leg veins, and like all vein treatment, there can be some shadowing when the vein closes.
It is another agent for sclerotherapy
Asclera is the newest agent for sclerotherapy. It is Polidocanol, which has been in use for a long time, but just recently gained FDA approval. The shadowed side effect is usually from an unskilled surgeon...
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What is Asclera?
Asclera (Polidocanol) is a sclerotherapy solution that has been used in Europe for many years but has only recently been approved by the FDA for treatment in the US. It essentially irritates the lining of the vessels causing them to become ineffective and collapse. Unfortunately, as with the other sclerotherapy agents/solutions, you still run the risk of hemosiderin staining (that shadowing effect you asked about). Having used Asclera in our practice, we have found it very effective and less irritating to patients than other treatments.
Dr. Grant Stevens
fda approved sclerosant agent for small and medium sized spider veins. it is polidocanol and has been used in europe for years.
Newly Approved for Spider Veins
The long awaited FDA approval for Asclero (Polidocanol) finally was effectuated March 30 this year. It seems to me that there have been rumors that this sclerosing agent would be approved for the last thirty years. Sure Polidocanol has been used in a number of countries, especially Europe, for years, but technically it was illegal to use in the United States, Unlike many drugs which are used off label, polidocanol had no FDA indication, and therefore was regarded by governmental eyes as being illegal. Still, due to its effectiveness, some physicians have been using this regularly by "smuggling" it into the country from Germany or France.
The reason these physicians were taking this risk is that, most feel, it is the best sclerosing agent around,. It was originally developed as an anesthetic. Thus, unlike other agents such as hypertonic saline, there is little, if any burning or pain. Another advantage is that it is much more forgiving than saline. If the spider vein is missed, no worry. Unlike saline, which risks an ulcer, there is minimal tissue necrosis ( tissue death) around the site.
The allergic potential is quite a bit lower than Sodium tetradecyl sulfate ( Sotradecol), an agent which has been FDA approved for years. However, there still exists the potential for anaphylaxis, and subsequent death. A number of years ago, a patient consulted me and transcribed polidocanol in her allergy list. When queried, she related how she almost died from injections of polidocanol for spider veins. So, though very rare, this untoward event can happen
Nonetheless, this is a very effective and ultimately safe agent.
As with all sclerosing agents, it acts by damaging the vessel wall. This injury causes the vessel to close and become fibrotic. The body subsequently eliminates the tissue. Asclero will be most effective for spider veins ( the little purple veins) and the larger reticular veins (reddish-blue).
Asclera: A sclerosing agent for treatment of varicose or prominent veins.
This is an agent which has been available all over the world and is used to shut down prominent veins. It is essentially a chemical (detergent) which sclerosis irritates the lining of the vein when injected which causes them to clot and subsequently occlude. It is very popular in other parts of the world and has a relatively high safety profile when used properly in the hands of an experienced injector. It was recently approved by the FDA for treating lower extremity veins but it is commonly used off-label for treatment of prominent hand veins
These answers are for educational purposes and should not be relied upon as a substitute for medical advice you may receive from your physician. If you have a medical emergency, please call 911. These answers do not constitute or initiate a patient/doctor relationship.