A novel biodegradable frontal sinus stent (MgNd2): a long-term animal study.
The frontal sinus recess consists of anatomically narrow passages that are prone to stenosis in endonasal frontal sinus surgery for chronic sinus disease. Over the past 100 years, diverse frontal sinus stents have been developed and evaluated in clinical and animal studies. However, superinfection, formation of granulations tissue, stent dislocation and late stenosis of the duct have remained challenges and subject of debate in the literature. Currently developed biodegradable materials, including rare earth-containing magnesium alloys are promising candidates for application as temporary implant materials. The Mg 2 % wt Nd alloy (MgNd2) was used to design a nasal stent that fit the porcine anatomy. In the current study, we evaluate biocompatibility, biodegradation and functionality of a frontal sinus stent in 16 minipigs over 6 months. Intraoperative endoscopy revealed free stent lumen in all cases. Blood examination and clinical examinations indicated no systematic or local inflammation signs. The histopathology and elements analysis showed a very good biocompatibility. The μ-computed tomography-based volumetric analysis showed substantial stent degradation within 6 months. Our MgNd2 based stent appears to be a promising, solid basis for the development of a frontal sinus stent for clinical use.
Department of Otorhinolaryngology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, Hannover, Germany. durisin.martin@mh-hannover.de.
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M
Durisin
Institut für Werkstoffkunde (Materials Science), Leibniz Universität Hannover, An der Universität 2, 30823, Hannover, Germany.|Department of Materials Science and Engineering, Michigan Technological University, 1400 Townsend Dr., Houghton, MI, 49931, USA.
J M
JM
Seitz
Department of Orthopedic Surgery, CrossBIT, Center of Biocompatibility and Implant-Immunology, Hannover Medical School, Feodor-Lynen-Straßee 31, 30625, Hannover, Germany.
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J
Reifenrath
Department of Otorhinolaryngology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, Hannover, Germany.
C M
CM
Weber
Institut für Werkstoffkunde (Materials Science), Leibniz Universität Hannover, An der Universität 2, 30823, Hannover, Germany.
R
R
Eifler
Institut für Werkstoffkunde (Materials Science), Leibniz Universität Hannover, An der Universität 2, 30823, Hannover, Germany.
H J
HJ
Maier
Department of Otorhinolaryngology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, Hannover, Germany.
T
T
Lenarz
Institut für Werkstoffkunde (Materials Science), Leibniz Universität Hannover, An der Universität 2, 30823, Hannover, Germany.
C
C
Klose
D020341:Absorbable Implants; D000497:Alloys; D000818:Animals; D005626:Frontal Sinus / Q000000981:diagnostic imaging / Q000601:surgery*; D008274:Magnesium; D023421:Models, Animal; D015607:Stents; D013552:Swine; D013556:Swine, Miniature
D000497:Alloys; D008274:Magnesium
Animal study; Chronic sinusitis; Frontal stent; Magnesium alloys; Sinus surgery; μ-computed tomography