Two new versions of a pioneering platinum-based treatment for malignant bile duct structures have been approved for use in Europe and the US.

Boston Scientific Corporation received clearance from the US Food and Drug Administration for the WallFlex Biliary RX uncovered stent three years ago.

However, it has now confirmed that the fully-covered and partially-covered iterations of the palliative treatment have been given the green light to be marketed and rolled out.

"The WallFlex Biliary RX Stent System represents the next stage in self-expandable metal stent technology," said Kenneth F Bimoeller, Director of Interventional Endoscopy at California Pacific Medical Center and an investigator for the fully covered stent study.

"[It] has greater flexibility to aid with placement in tortuous anatomies and new features such as flared ends that may reduce the risk of migration."

The system makes use of a platinum-cored Nitinol construction which is capable of improving performance in three key areas - radial force, flexibility and radiopacity.

However, Michael Phalen, President of Endoscopy at the firm, explained that the inclusion of the Platinol Wire in the latest versions offers further advances in each of these categories.

"The WallFlex Biliary RX Stent leverages existing Boston Scientific technologies, while advancing performance with new features such as a unique Platinol Wire construction," he said.

"We believe we are truly delivering the next generation of stents for the treatment of malignant bile duct strictures."

Preliminary studies into the fully-covered stent last year revealed that it achieved low rates of re-intervention (two per cent), plus almost no migration (two per cent).

Further tests indicated that the partially-covered version could have the ability to palliate the majority of patients suffering from malignant biliary obstructions, which are generally caused by pancreatic cancer.

Boston Scientific, which was formed in 1979, recently completed the purchase of long-time competitor Guidant in a deal worth approximately $27 billion.

Source:

Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex(R) Biliary RX Covered Stents (06/10/09)

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