Boston Scientific, a developer, manufacturer and marketer of medical devices, has received FDA approval for its Express LD Iliac Premounted Stent System for use in iliac arteries.
Boston’s Express LD Iliac Stent is the low-profile, premounted, balloon-expandable stent approved by the FDA for use in treating iliac artery disease. It has been designed to be highly deliverable, and its Tandem Architecture Stent design is engineered to balance strength, flexibility and conformability. The company said that it plans to launch the product immediately in the US.
The Express LD Iliac Stent has also received CE Mark approval and is currently approved for iliac use in a number of international markets.
Barry Katzen of Baptist Cardiac and Vascular Institute in Miami, said: “Boston Scientific’s Express LD Iliac Stent incorporates a flexible stent design and is engineered for improved deployment accuracy, two critical treatment components. 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.”
Joe Fitzgerald, senior vice president and president of endovascular unit at Boston Scientific, said: “The Express LD Iliac Stent offers an attractive option for physicians treating the iliac arteries. 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.”
Luc Stockx of Limburgs Vaatcentrum Ziekenhuis, Belgium, said: “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. Deployment accuracy and radial strength can play crucial roles in these types of procedures, and the Express LD Stent is designed to deliver both.”