Products - Ella CS

Products

BD Stent tracheal

Ella

Basic description

The ELLA-BD Stent Tracheal is a worldwide unique self-expandable tracheal biodegradable stent that disintegrates in the human body and disappears completely in 11- to 12 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

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 disintegrates in the human body and disappears completely within 3 months (approximately 11 to 12 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.
Stent integrity and radial force are maintained for 6 to 8 weeks of implantation. Subsequently, the radial force gradually decreases until the complete disintegration of the material after 11 to 12 weeks.
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.

Implantation

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.

BD stent tracheal compression and loading

Available sizes

REF No. Nominal stent body diameter [mm] Nominal stent length
[mm]
Delivery system
019-14-16-040 16 40 26 F / 18 F
60 cm
019-14-16-050 50
019-14-16-060 60
019-14-16-070 70
019-14-18-040 18 40
019-14-18-050 50
019-014-18-60 60
019-014-18-70 70
019-014-20-40 20 40
019-014-20-50 50
019-014-20-60 60
019-014-20-70 70

Leaflets

Video

COMPRESSION

Publications

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

For more information on publications, visit our Education.section.