Biliary Stent

  • Flap with Lasso
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Biliary Stent

Introduction

A novel ‘‘anchoring flap’’ (FCSEMS-AF) system made of four flaps in the proximal end to prevent anti-migration. One proximal lasso with gold marker is a cutting-edge advance in therapeutic endoscopy for benign biliary diseases as inversion retrieval.

Indications for use (Intended use)

The device is indicated for palliative treatment of bile duct malignant and/or benign strictures.

Product Overview

Features, Benefits
Features Benefits
Flaps in proximal ends Anchorage to the choledochal wall and preventing both proximal and distal stent migration*
Lasso with Gold Stent inside-out removal

※ Alternatively using a snare to remove
Clinical Study, B. Mangiavillano., et al1
Clinical Study B. Mangiavillano., et al1 Do Hyun Park, et al2
Migration Rate 3.3% (n=1 of 32) One at 125 days after placement 0% (n=22)
Successful Removal Rate 93.7% (n=30 of 32) One of the two patients in whom stent removal was not attempted died on day 122 after stent placement from underlying cardiovascular disease. The leak had clinically closed, and the abdominal drain had been removed. One patient was lost to follow-up 100% (n=22%)

Resources

ORDERING INFO.

Endoscopic Application

*Increment of 10mm
Stent(mm), Delivery Device
Stent(mm) Delivery Device
Diameter Usable Length* Total Length Length(mm) Diameter(mm/fr)
BCT-08-040-180 8 23 40 1800 3.4/10.2
BCT-08-120-180 103 120 1800 3.4/10.2
BCT-10-040-180 10 23 40 1800 3.4/10.2
BCT-10-120-180 103 120 1800 3.4/10.2

RESOURCES

B. Mangiavillano, G. Manes, et al. The Use of Double Lasso, Fully Covered Self-Expandable Metal Stents with New ‘‘Anchoring Flap’’ System in the Treatment of Benign Biliary Diseases. Dig Dis Sci DOI 10.1007/s10620-014-3158-7.

Do Hyun Park, Sang Soo Lee, et al. Anchoring flap versus flared end, fully covered self-expandable metal stents to prevent migration in patients with benign biliary strictures: a multicenter, prospective, comparative pilot study. Gastrointest Endosc 2011;73:64-70.

※Sizing and availability varies by country

All medical devices have associated risks. Please refer to the package insert and other labeling for a complete list of indications, contraindications, precautions and warnings. For further information on the Products, please contact your local M.I.Tech(Hanarostent) Representative.