October 21, 2010
BSX Gains Two Approvals For Plastic Stent System
By Matthew L. Brown
Natick-based medical device maker Boston Scientific Corp. said it has received clearance from the U.S. Food and Drug Administration and CE Mark approval for a plastic stent system.
The system is already available in Europe and other markets. The company intends to offer it in the United States beginning this quarter.
The CE Mark is a European health and safety designation.
The stent is designed for the treatment of biliary strictures, a narrowing of the bile duct between the liver and the small intestine. The system can be implanted by an endoscopic procedure rather than invasive surgery.
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