Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has approved its Express® LD Iliac Premounted Stent System for use in iliac arteries. The Express LD Iliac Stent is the first and only low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. The Company said it plans to launch the product immediately in the United States.
The Express LD Iliac Stent is designed to be highly deliverable, and its Tandem Architecture™ Stent Design is engineered to balance strength, flexibility and conformability.
Atherosclerotic iliac disease occurs when plaque builds within the arteries that supply blood to the legs, which can lead to poor blood flow, leg pain and other complications. The disease can be treated with medication, surgery or angioplasty.
"Boston Scientific's Express LD Iliac Stent incorporates a flexible stent design and is engineered for improved deployment accuracy, two critical treatment components," said Barry Katzen, M.D., F.A.C.R, F.A.C.C., of Baptist Cardiac and Vascular Institute in Miami. "With an approved iliac indication, the Express LD Stent offers physicians a less-invasive alternative to surgery for our patients suffering from iliac artery disease."
"The Express LD Iliac Stent offers an attractive option for physicians treating the iliac arteries," said Joe Fitzgerald, Senior Vice President and President of Boston Scientific's Endovascular Unit. "This approval reinforces our leadership in the treatment of peripheral artery disease and adds to our portfolio of peripheral vascular stent indications, which includes the Carotid WALLSTENT® Endoprosthesis for carotid artery disease and the Express® SD Stent for renal artery disease."
The Express LD Iliac Stent has received CE Mark approval and is currently approved for iliac use in a number of international markets.
"I have found that the benefits of a balloon-expandable stent like the Express LD Iliac Stent can be extremely important when working in atherosclerotic iliac lesions," said Luc Stockx, M.D., of Limburgs Vaatcentrum Ziekenhuis, Belgium. "Deployment accuracy and radial strength can play crucial roles in these types of procedures, and the Express LD Stent is designed to deliver both."
SOURCE Boston Scientific Corporation