Boston Scientific stent gets regulatory approvals
Boston Scientific Corp., the Natick medical device maker, said it has gotten regulatory approvals to market an esophageal stent in the United States, Europe, and other international markets.
The stent in question, shown in a company photo at right, is designed to treat obstructions in patients with certain kinds of esophageal cancers, the company said in a press release.
"Patients with obstructions due to esophageal cancer may have difficulty swallowing, resulting in severely limited quality of life," the release said. "Complete blockages of the esophagus can prevent liquid consumption. The WallFlex Esophageal Stent allows physicians to re-establish patency (openness) of the esophagus, enabling resumption of oral intake."
Today's news is that this WallFlex Esophageal Stent has received 510(k) clearance from the US regulators at the Food and Drug Administration as well as approval from European regulators, Boston Scientific said.
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