Medtronic announced today U.S. availability of its VenaSeal closure system. This is the first procedure of its kind approved for the treatment of symptomatic venous reflux (varicose veins) in the U.S.
The minimally invasive procedure, which uses a proprietary medical adhesive to close superficial veins of the lower extremities, has been approved through the FDA’s PMA process. It does not require sedatives or the use of tumescent anesthesia.
A physician guides a catheter through a small access site with the help of ultrasound, then the VenaSeal adhesive is administered, which closes the diseased vein, forcing blood to re-route through other health veins.
Varicose veins develop as a result of valves in the veins malfunctioning and thus allowing blood to flow backward. This affects more than 30 million Americans, as a release stated, and it’s more common in women who have had at least two pregnancies.
“Patients are often told their varicose veins are only a cosmetic issue, but varicose veins are a sign of a condition known as venous insufficiency, which can cause symptoms that impact quality of life, and over time can lead to more serious problems,” Kathleen Gibson, M.D., Lake Washington Vascular, Seattle, said in a release. She performed the first treatment of a U.S. patient on October 21, 2015 with the VenaSeal closure system since approval. “Left untreated the venous insufficiency often progresses, and can cause leg pain, leg and ankle swelling, leg heaviness and fatigue, skin changes or rashes, ulcers and open wounds.”
VenaSeal has previously been available in New Zealand, Chile, South Africa, Australia, Canada, Europe, United Arab Emirates and Hong Kong.
Here’s a look at how it works:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
