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Basic description
The ELLA-BD Stent Biliary THP is a worldwide unique self-expandable biliary biodegradable stent that degrades in the human body usually 3 to 6 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.
Indication
The ELLA-BD Stent Biliary THP is intended for patients aged 18 and older and is indicated for the treatment of benign biliary strictures.
Features / Benefits
The ELLA-BD Stent Biliary THP degrades in the human body usually in 3 to 6 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.
The 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 6 months.
The ELLA-BD Stent Biliary THP eliminates the need for repeated exchange of a biliary catheter and extraction of non-degradable stents which decreases the risk of infection or other post-procedural complications.
Sufficient radial force to maintain the bile duct lumen open in benign strictures.
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, therefore the stent is equipped with gold markers - 1 piece at both stent ends.
The delivery system with braided sheath is kink-resistant. The atraumatic olive and the radiopaque ring at the end of the delivery system allow easy insertion. The delivery system also has the option of retracting the partially released stent during implantation, up to 60% of the stent length.
MRI compatibility - "MR Conditional", compatible with 1.5 Tesla and 3 Tesla static magnetic field.
Patent protected
Implantation
The stent is supplied sterile and is packed separately from the delivery system and the compression tool (ie, a tool for easier compression of the stent into the delivery system). The stent is inserted percutaneously under fluoroscopic control. Just prior to implantation, the stent has to be manually compressed into the delivery system. We recommend using a 0.035 ”(0.89 mm) / 180 cm ultra stiff guidewire for the implantation.
Available sizes
| REF No. | Nominal stent body diameter [mm] |
Nominal stent length [mm] |
Delivery system |
|---|---|---|---|
| 019-15-08-030 | 8 | 30 |
11,8 F 60 cm |
| 019-15-08-040 | 40 | ||
| 019-15-08-050 | 50 | ||
| 019-15-08-060 | 60 | ||
| 019-15-08-070 | 70 | ||
| 019-15-08-080 | 80 | ||
| 019-15-10-030 | 10 | 30 | |
| 019-15-10-040 | 40 | ||
| 019-15-10-050 | 50 | ||
| 019-15-10-060 | 60 | ||
| 019-15-10-070 | 70 | ||
| 019-15-10-080 | 80 |
Publications
Spanish group BiELLA (SERVEI). Absorbable stents for treatment of benign biliary strictures: long-term follow-up in the prospective Spanish registry
De Gregorio MA, Criado E, Guirola JA, Alvarez-Arranz E, Pérez-Lafuente M, Barrufet M, Ferrer-Puchol MD, Lopez-Minguez S, Urbano J, Lanciego C, Aguinaga A, Capel A, Ponce-Dorrego MD, Gregorio A
Eur Radiol. 2020 Aug;30(8):4486-4495. doi: 10.1007/s00330-020-06797-7. Epub 2020 Mar 27. PMID: 32221684.
Benign biliary strictures refractory to standard bilioplasty treated using polydoxanone biodegradable biliary stents: retrospective multicentric data analysis on 107 patients
Mauri G, Michelozzi C, Melchiorre F, Poretti D, Pedicini V, Salvetti M, Criado E, Falcò Fages J, De Gregorio MÁ, Laborda A, Sonfienza LM, Cornalba G, Monfardini L, Panek J, Andrasina T, Gimenez M
Eur Radiol. 2016 Nov;26(11):4057-4063. doi: 10.1007/s00330-016-4278-6. Epub 2016 Mar 4. PMID: 26943135
Biodegradable biliary stents: A new approach for the management of hepaticojejunostomy strictures following bile duct injury. Prospective study
Giménez ME, Palermo M, Houghton E, Acquafresca P, Finger C, Verde JM, Cúneo JC.
Arq Bras Cir Dig. 2016 Apr-Jun;29(2):112-6. doi: 10.1590/0102-6720201600020012. PMID: 27438039; PMCID: PMC4944748.
Biodegradable Biliary Stents for Percutaneous Treatment of Post-liver Transplantation Refractory Benign Biliary Anastomotic Strictures
Battistel M, Senzolo M, Ferrarese A, Lupi A, Cillo U, Boccagni P, Zanus G, Stramare R, Quaia E, Burra P, Barbiero G
Cardiovasc Intervent Radiol. 2020 May;43(5):749-755. doi: 10.1007/s00270-020-02442-4. Epub 2020 Mar 4. PMID: 32133551.
Biodegradable versus multiple plastic stent implantation in benign biliary strictures: A systematic review and meta-analysis
G Almeida G, Donato P
Eur J Radiol. 2020 Apr;125:108899. doi: 10.1016/j.ejrad.2020.108899. Epub 2020 Feb 13. PMID: 32113154.
Biodegradable biliary stent implantation in the treatment of benign bilioplastic-refractory biliary strictures: preliminary experience
Mauri G, Michelozzi C, Melchiorre F, Poretti D, Tramarin M, Pedicini V, Solbiati L, Cornalba G, Sconfienza LM
Eur Radiol. 2013 Dec;23(12):3304-10. doi: 10.1007/s00330-013-2947-2. Epub 2013 Jul 11. PMID: 23842947.
Management of benign intrahepatic bile duct strictures: initial experience with polydioxanone biodegradable stents
Petrtýl J, Brůha R, Horák L, Zádorová Z, Dosedel J, Laasch HU
Endoscopy. 2010;42 Suppl 2:E89-90. doi: 10.1055/s-0029-1243880. Epub 2010 Mar 1. PMID: 20195981.
Beneficial Effect of a Resorbable Biliary Stent in Living Donor Liver Transplantation
Sánchez-Cabús S, Calatayud D, Ferrer J, Molina V, Pavel MC, Sampson J, Saavedra D, Fondevila C, Fuster J, García-Valdecasas JC
Eur Surg Res. 2016;56(3-4):123-31. doi: 10.1159/000443271. Epub 2016 Feb 4. PMID: 26840276.
The novel use of a biodegradable stent placed by percutaneous transhepatic cholangiography for the treatment of a hepaticojejunostomy biliary leak following an extended left hepatectomy and pancreaticoduodenectomy
Jones L, Moir J, Brown C, Williams R, French JJ.
Ann R Coll Surg Engl. 2014 Sep;96(6):e1-3. doi: 10.1308/003588414X13946184901326. PMID: 25198957; PMCID: PMC4474217
Percutaneous Patency Recovery and Biodegradable Stent Placement in a Totally Occluded Hepaticojejunostomy After Paediatric Living Donor Liver Transplantation
Huespe PE, Oggero S, de Santibañes M, Boldrini G, D Agostino D, Pekolj J, de Santibañes E, Ciardullo M, Hyon SH
Cardiovasc Intervent Radiol. 2019 Mar;42(3):466-470. doi: 10.1007/s00270-018-2115-9. Epub 2018 Nov 12. PMID: 30420998.
For more information on publications, visit our Education section.
