Truls Hauge MD, PhD, Associate Professor
Dept. of Gastroenterology, Oslo University Hospital - Ullevål, Norway
"The absence of stent removal is important, but also the patients opinion. In our small survey patients who had experienced both dilatation and stent tended to choose stent. Even our patient who got the first BD stent in 2008, still prefer BD stent all 3-4 months compared to dilatation all 4-6 weeks."
Prof. Pier Alberto Testoni
Head of Gastroenterology and digestive endoscopy, Ospedale San Raffaelle di Milano, Italy
"The auto-expandable, ELLA-CS Biodegradable Stent has been used in our Division since the entry of the device in the market. We found the stent ideal for treating benign strictures, where the risk of stent migration is high with fully covered stents. The stent is also the unique device that can be safely used for treating benign post-surgical strictures of the upper G.I. tract.
In case of severe strictures, several BD Stents can be placed without the need for removal, procedure which may be technically difficult and uncomfortable for the patient."
The BD Stent is a worldwide unique self-expandable esophageal biodegradable stent that degrades in the human body usually 3 to 4 months after the implantation. Therefore, it is an ideal solution for temporary use in benign indications, where it is not necessary to extract it from the body like other non-degradable stents (including possible extraction from the stomach due to stent migration). In specific cases, custom-made production is possible.
BD Stent is intended for patients aged 18 and older and is indicated for management of refractory benign esophageal stenoses:
- refractory esophageal stenoses (peptic, caustic, or anastomotic) in which the standard therapy with repeated dilation failed.
Features / Benefits
The BD Stent degrades in the human body usually in 3 to 4 months. This reduces the number of interventions and hospital visits.
The stent is made of polydioxanone, an absorbable material (polymer) used in medicine as a surgical suture for more than 30 years.
Stent integrity and radial force are maintained for 6 to 8 weeks after implantation. Subsequently, the radial force gradually decreases until the degradation of the material after 3 to 4 months.
The pH value affects the stent degradation process. At higher pH, stent degradation is slower, at lower pH, stent degradation is faster.
Low migration is achieved by uncovered stent design.
Polydioxanone is not visible under X-ray, so the stent is equipped with gold markers - 3 pieces at both ends and 1 piece at the midpoint of the stent.
MRI compatibility - "MR Conditional", compatible with 1.5 Tesla and 3 Tesla static magnetic field.
The stent is supplied sterile and is packaged separately in addition to the delivery system and compressor (ie, a means for easier compression of the stent into the delivery system). Just prior to implantation, the stent must be manually compressed into the delivery system. We recommend using a 0.035 ”(0.89 mm) / 220 cm ultra stiff guidewire for the implantation.
|REF No.||Nominal stent body diameter [mm]||Nominal stent flares diameter [mm]||
Nominal stent length
28 F / 18 F
Dilation or biodegradable stent placement for recurrent benign esophageal strictures: a randomized controlled trial
Daisy Walter, Maarten W. Van Den Berg, Meike M. Hirdes, Frank P. Vleggaar, Alessandro Repici, Pierre H. Deprez, Laurence Lovat, Bartolomé L. Viedma, Bas L. Weusten, Raf Bisschops, Renan Haidry, Elisa Ferrara, Keith J. Sanborn, Erin E. O’Leary, Jeanin E. Van Hooft, Peter D. Siersema
Endoscopy. 2018 Mar. Georg Thieme Verlag KG Stuttgart. New York, ISSN 0013-726X
The use of reabsorbable ELLA stent in the treatment of benign stenosis
D. Esposito, F. Calabrese, L. Fanti, E. Viale, P.A. Testoni
Abstracts of the 24th National Congress of Digestive Diseases / Digestive and Liver Disease 50/S2 (2018) e63–e238
Endoscopically placed stents: a useful alternative for the management of refractory benign cervical esophageal stenosis
Nogales Óscar, Clemente Ana, Caballero-Marcos Aránzazu, García-Lledó Javier, Pérez-Carazo Leticia, Merino Beatriz, López-Ibáñez María, Pérez Valderas María Dolores, Bañares Rafael, González-Asanza Cecilia
Single and sequential biodegradable stent placement for refractory benign esophageal strictures: a prospective follow-up study
M. M. C. Hirdes, P. D. Siersema, P. G. A. van Boeckel, F. P. Vleggaar
Endoscopy. 2012 Jul;44(7):649-54.
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