The ELLA-BD Stent Tracheal is a worldwide unique self-expandable tracheal 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.
CE mark pending
ELLA-BD Stent Tracheal is intended for patients aged 18 and older and is indicated for the treatment of benign tracheal stenoses unless primary surgery is indicated.
Features / Benefits
The ELLA-BD Stent Tracheal 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 of 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, therefore the stent is equipped with gold markers - 1 piece at both stent ends.
MRI compatibility - "MR Conditional", compatible with 1.5 Tesla and 3 Tesla static magnetic field.
The stent is supplied sterile and is packed separately from the delivery system. Just prior to implantation, the stent must be manually compressed into the delivery system. The stent is inserted under bronchoscopic control through a rigid bronchoscope.
|REF No.||Nominal stent body diameter [mm]||
Nominal stent length
26 F / 18 F
Biodegradable polydioxanone stents in the treatment of adult patients with tracheal narrowing
Stehlik L, Hytych V, Letackova J, Kubena P, Vasakova M.
BMC Pulm Med. 2015 Dec 21;15:164. doi: 10.1186/s12890-015-0160-6. PMID: 26690793; PMCID: PMC4687362
Our own method of fixation of biodegradable tracheal stent
Hytych V, Horazdovsky P, Stehlik L, Pracharova S, Pohnan R, Lefnerova S, Vasakova M
Bratisl Lek Listy. 2015;116(5):340-2. doi: 10.4149/bll_2015_064. PMID: 25924646
Initial experience with a new biodegradable airway stent in children: Is this the stent we were waiting for?
Antón-Pacheco JL, Luna C, García E, López M, Morante R, Tordable C, Palacios A, de Miguel M, Benavent I, Gómez A
Pediatr Pulmonol. 2016 Jun;51(6):607-12. doi: 10.1002/ppul.23340. Epub 2015 Nov 19. PMID: 26584412
First experience with biodegradable airway stents in children
Vondrys D, Elliott MJ, McLaren CA, Noctor C, Roebuck DJ
Ann Thorac Surg. 2011 Nov;92(5):1870-4. doi: 10.1016/j.athoracsur.2011.07.042. Epub 2011 Oct 31. PMID: 22051281
The role of bioresorbable intraluminal airway stents in pediatric tracheobronchial obstruction: A systematic review
Stramiello JA, Mohammadzadeh A, Ryan J, Brigger MT
Int J Pediatr Otorhinolaryngol. 2020 Dec;139:110405. doi: 10.1016/j.ijporl.2020.110405. Epub 2020 Sep 30. PMID: 33017664
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