FDA clears carotid artery stenting

Natick, United States, October 24: The Boston Scientific Corporation has announced that the US Food and Drug Administration (FDA) approved carotid WALLSTENT Endoprosthesis, a device used for the treatment of patients with arterydefine blockades, belonging to the high risk category, and in need of immediate surgery.

Carotid stents offer doctors a generally safe and a less invasive procedure. It is a self expanding stent designed to re-open the carotid arterydefine by treating stenoses to improve the flow of blood to the brain. A tiny filter is used to catch the built up plaque inside the artery. The debris that is stirred up during the stenting technique is removed, preventing its flow to the brain, where it can trigger a stroke.

FDA approved the system, based on clinical safety and effectiveness. It lifted the previous restrictions on the company set in 2006 by a corporate warning letter prohibiting the approval of new products.

Hank Kucheman, Senior Vice President of Boston Scientific Cardiovascular Business was elated at providing the US with the new technology. “Excellent patient outcome and ease of use in complex anatomy have already made this system the number one option for treating carotid artery disease.”

Barry T Katzan, MD, medical director, Baptist, Cardiacdefine and Vasculardefine Institute in Miami states that the closed–cell design of “Carotid WALLSTEN Endoprothesis provides increased scaffolding for optimal lesion coverage and smooth inner lumen, making it an attractive device, one of its kind for US physicians and their patients”.

Stenting, the outstanding option for tackling carotid artery disease, uses a small metal mesh tube fitted inside a carotid artery, to increase the flow of blood blocked by plaque. The procedure requires the surgeon to cut into the neck artery and insert the stent inside the damaged artery. The process removes the blockage, forcing open the arteries, regulating adequate flow of blood.

The stint filter system to treat bi-lateral carotid artery blockages is perhaps the only one approved in the US. The Carotid WALLSTENT Endoprothesis stent is widely used in Europe and other international markets. The company now plans to launch the product in the U.S. with immediate effect.