CE Mark for Boston Scientific’s New Stent

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Boston Scientific Corporation (BSX) recently announced the receipt of CE Mark approval in Europe for the WallFlex Esophageal Fully Covered Stent. The device has been designed to treat refractory benign esophageal strictures.

Both fully-covered and partially-covered WallFlex Esophageal Stents have previously received CE Mark and U.S. Food and Drug Administration (FDA) clearance for the palliative treatment of malignant esophageal strictures. However, WallFlex Esophageal Stents do not have the approval for removal from malignant strictures. They are also not sanctioned in the U.S. for the treatment of refractory benign esophageal strictures.

Benign or noncancerous esophageal stricture is a condition characterized by narrowing of the esophagus by scar tissue. Though not malignant, it can cause problems in swallowing and increase choking risks. The primary treatment of the condition is dilation of the esophagus that may have to be repeated after regular intervals.

The WallFlex Esophageal Stent from Boston Scientific is designed for gradual expansion and is combined with a Permalumesilicone coating that helps to prevent tumor in-growth, seal concurrent esophageal fistulas and also help reduce food impaction.

Further, the Teflon coated polyester suture of the WallFlex Esophageal Stent from Boston Scientific facilitates removal from refractory benign strictures for upto eight weeks. This feature is particularly helpful for patients as they have to make less number of hospital visits to undertake additional dilations to treat their stricture.

The WallFlex Stent from Boston Scientific offers physicians clear visualization during fluoroscopy, guaranteeing correct placement of the device during the treatment process. Moreover, its small profile and radiopacity facilitate accurate placement making stent removal easy and safe for healthcare experts.

The CE Mark approval of the WallFlex Fully Covered Stent of Boston Scientific comes as welcome news for physicians in the European Union who are involved in the treatment of benign esophageal strictures.

The commercial availability of Boston Scientific’s WallFlex Stent in the European market promises fresher avenues for revenue growth in the near future.

Currently, Boston Scientific carries a Zacks Rank #3 (Hold).

Investors interested in the medical products industry can also look at other stocks like NuVasive, Inc. (NUVA), Baxter International Inc. (BAX) and Covidien plc (COV). While NUVA carries a Zacks Rank #1 (Strong Buy), COV and BAX hold a Zacks Rank #2 (Buy).

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