BD biliary

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BD biliary

References

Description

Features

Implantation

Available sizes

Publications

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

ELLA-BD Stent Biliary THP is a worldwide unique self-expanding biodegradable stent intended for use in the biliary ducts. It typically degrades in the human body within 3–6 months after implantation. This property makes it suitable for temporary use in benign indications where subsequent removal is not necessary, unlike stents made of non-degradable materials.

Indications

ELLA-BD Stent Biliary THP is intended for patients over 18 years and is indicated for the treatment of benign biliary strictures.  

Features / Benefits

ELLA-BD Stent Biliary THP typically degrades in the human body within 3–6 months, which reduces the number of medical interventions and hospital visits. The stent is made of polydioxanone, a biodegradable polymer used in medicine for more than 30 years in the form of surgical suture material.  

The integrity and radial force of the stent are maintained for 6–8 weeks after implantation; thereafter, the radial force gradually decreases until the material fully degrades within 3–6 months.

The pH value affects the stent degradation process. In the human body, degradation tends to be slower under neutral pH but accelerates in acidic pH.

Low migration is ensured by the uncovered stent design.

Polydioxanone is not visible under X-ray imaging; therefore, gold radiopaque markers are placed at both ends of the stent. The stent is MRI-compatible (“MR Conditional”) at static magnetic field strengths of 1.5 Tesla and 3 Tesla.

IMPLANTATION PROCEDURE

The stent is supplied sterile. The package includes a kinking resistant delivery system, compressing tool, and the stent packed in a protective foil. The delivery system allows recapturing of a partially deployed stent during implantation, up to 60 % of the stent length. Immediately before implantation, the stent must be manually compressed into the delivery system. The stent is implanted under fluoroscopic guidance, and for proper positioning, the use of a 0.035″ (0.89 mm) guidewire is recommended.

3D animation – compression and 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

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.

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

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.

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.

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.

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.

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.

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.

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

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.