Boston Scientific's WallFlex esophageal stent wins CE Marking, 510(k) clearance

November 20, 2009 by MassDevice staff

Boston Scientific Corp. (BSX) won 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval for its WallFlex fully covered esophageal stent.

The Natick, Mass.-based medical devices monolith's latest stent is designed to treat malignant esophageal obstructions caused by esophageal cancer. A partially covered version of the device won 510(k) clearance and a CE Mark last year.

Boston Scientific said the WallFlex stent allows esophageal cancer patients to keep their esophagus' open so that they can eat and drink. It's covered with a silicone product called Permalume that's designed to prevent tumors from growing into the device and to seal between concurrent strictures in the esophagus. The coating also helps prevent food from sticking in the stent.

BSX's WallFlex line includes fully and partially covered biliary, enteral and esophageal stents. The latest round of regulatory approvals means all of the company's WallFlex products are on the market in Europe and the U.S.

Boston Scientific initially posted a $200 million third-quarter profit on $2.03 billion in sales during the three months ended Sept. 30. The gain compares favorably with year-ago results, when the company lost $64 million on sales of $1.98 billion and marked its best quarterly profit since posting a $111 bottom line in June 2007.

But the profit swung to a loss after the company settled a case with the U.S. Justice Dept. for $296 million, related to its Guidant acquisition and the recall of two of its implantable cardiac defibrillators. The settlement meant a $294 million charge hit the books for BSX's 2009 third quarter, reversing the $200 million in Q3 profits into a $94 million net loss. That prompted the company to lower its full-year earnings-per-share guidance buy 20 cents, from $.043-$.048 per share to $0.23-$0.28 per share.

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