Boston Scientific WallFlex Biliary RX Stent Study Succeeds - Analyst Blog


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Detailed results of the multinational scientific study conducted by Massachusetts-based medical equipment manufacturer Boston Scientific Corporation ( BSX ) has been recently published in the August issue of the prominent journal Gastroenterology.

The primary purpose of this study was to examine the effectiveness and safety of fully covered self-expanding metal stents (FCSEMS) in the treatment of biliary obstruction in benign bile duct strictures patients. It also aimed at evaluating the frequency and durability of benign biliary strictures in the long run.

This non-randomized study was conducted at 13 centers in 11 countries across 5 continents, wherein 187 benign bile duct stricture patients were implanted with Boston Scientific's Fully Covered WallFlex Biliary RX Stent. The WallFlex Biliary RX Stent has received CE Mark in Europe for curing biliary strictures produced by malignant neoplasms as well as for benign biliary strictures therapy.

Following extended indwell for up to 12 months, physicians removed these stents to deduce treatment success of bile duct obstruction.

The study results revealed 100% success rate of endoscopic removal of FCSEMS from the 155 patients who received the stents. Overall, the removal success of FCSEMS after extended indwell and stricture resolution was achieved for approximately 75% of patients in this trial.

The stricture resolution rates were 90.1% among patients who underwent scheduled FCSEMS removal. Moreover, the study results reflected the cost effectiveness of the FCSEMS treatment and its ability to potentially reduce the requirement for multiple sequential Endoscopic Retrograde Cholangiopancreatogram (ERCP) stent exchanges.

A follow-up of the patients under this study will be done over five years to determine the long-term durability of stricture resolution after stent removal.

Currently, Boston Scientific is enrolling patients for another multi-center, prospective, randomized study which will compare removable, self-expanding metal stents to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis. 

Currently, Boston Scientific has a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. ( ICUI ), Abaxis, Inc. ( ABAX ) and Conatus Pharmaceuticals Inc. ( CNAT ). While ICU Medical sports a Zacks Rank #1 (Strong Buy), Abaxis and Conatus hold a Zacks Rank #2 (Buy) each.

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