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BD Stent biliary

Ella

Personal referenceS

Dr. Giulio Barbiero

Medical Director, Azienda Ospedaliera di Padova, Italy

'Biodegradable Biliary Stents for Percutaneous Treatment of Post-liver Transplantation Refractory Benign Biliary Anastomotic Strictures. CVIR Cardiovasc Intervent Radiol (2020) 43:749-755 DOI 10.1007/s00270-020-02442-4'are:
1) "Biodegradable Biliary Stents (BBS) could be safely placed, with few side effects, for the treatment of refractory Benign Anastomotic Strictures (BAS) in the Liver Transplant (LT) setting."
2) "BBS placement in selected adult LT recipients had a success rate of 72% at a median follow-up time of 27 months according to Kaplan–Meier analysis".
3) "The introduction of BBS may offer a safe and effective option, especially among patients with refractory BAS, who otherwise would be surgically treated".
4) "BBS placement should be considered as a new tool for the management of BAS in adult LT setting."

Dr. Sung Ho Hyon

Hospital Italiano de Buenos Aires, Argentina

"We used a biodegradable stent for the first time in a 6-y.o. girl with intractable stricture of hepaticojejunostomy, who required a recanalization manoeuvre. After that, we inserted a biodegradable stent and the anastomosis is still patent more than 3.5 years later (Cardiovasc Intervent Radiol. 2019 Mar;42(3):466-470). We placed the biodegradable stent because we had read publications about its good results and in the case of paediatric patients, in particular, the problem is solved with a single admission to the operating room. In the standard balloon dilatation protocol, they must be admitted 3 times, which implies more ionizing radiation, more general anaesthesia procedures, more hospital stays, etc.

My hospital is the largest tissue and organ transplantation centre in the country, performing close to 60 liver transplants per year. A good proportion of liver recipients are in the paediatric population and may present stricture of hepaticojejunostomy in the follow-up period.
Traditionally, our treatment protocol has been percutaneous transhepatic cholangiography followed by three sessions of balloon dilatation. Alternatively, we have used biodegradable stents with excellent results."

Basic description

The ELLA-BD Stent Biliary THP is a worldwide unique self-expandable biliary biodegradable stent that disintegrates in the human body within 6 months after implantation (approximately 13 to 22 weeks). 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.

CE mark pending

Indication

The ELLA-BD Stent Biliary THP is intended for patients aged 18 and older and is indicated for the treatment of benign biliary stenoses.

Features / Benefits

The ELLA-BD Stent Biliary THP disintegrates in the human body and disappears completely within approximately 13 to 22 weeks. 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 complete disintegration of the material after 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.

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.

BD biliary stent compression and loading

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

Leaflets

Video

COMPRESSION

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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.

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