DV Stent tracheal

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DV Stent tracheal

Basic description

DV Stent Tracheal is a worldwide unique self-expanding biodegradable stent intended for use in the trachea. It typically degrades in the human body within 2 – 4 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.

The product is currently available as a custom-made device.

CE mark pending

INDICATIONS

DV Stent Tracheal is intended for patients over 18 years and is indicated for the treatment of benign tracheal strictures or tracheomalacia.

Features / Benefits

DV Stent Tracheal typically degrades in the human body within 2–4 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 2–4 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 delivery system, compressing tool, and the stent packed in a protective foil. Immediately before implantation, the stent must be manually compressed into the delivery system. The stent is implanted under bronchoscopic guidance through a rigid bronchoscope.

DV stent tracheal compression and loading

Available sizes

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

Publications

Ludek Stehlik, Debarya Guha, Sheetal Anandakumar, Alice Taskova and Martina Koziar Vasakova

BMC Pulm Med 24, 238 (2024).doi.org/10.1186/s12890-024-03057-y. PMID: 38750487 PMCID: PMC11094873

Federico Minen, Andrew Durward, Paul James, Athanasios Diamantopoulos, Haran Jogeesvaran, Gareth J Morgan, Andrew Nyman

Pediatr Pulmonol. 2023;1‐10., DOI: 10.1002/ppul.26670, PMID: 37728230 

Rocío Morante-Valverde, María López Díaz, Mª Carmen Luna-Paredes, Sara Proaño, Cecilia Castellano, Mª Dolores Méndez, Victoria Ramos, Juan L Antón-Pacheco

Pediatr Pulmonol. 2024 Oct;59(10):2517-2522. doi: 10.1002/ppul.27056. Epub 2024 May 9. PMID: 38721899

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

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.