A method to determine the kink resistance of stents and stent delivery systems according to international standards
The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery sy...
| Main Authors: | , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2016-09-01
|
| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2016-0064 |
| _version_ | 1819121251558359040 |
|---|---|
| author | Brandt-Wunderlich Christoph Schwerdt Christopher Behrens Peter Grabow Niels Schmitz Klaus-Peter Schmidt Wolfram |
| author_facet | Brandt-Wunderlich Christoph Schwerdt Christopher Behrens Peter Grabow Niels Schmitz Klaus-Peter Schmidt Wolfram |
| author_sort | Brandt-Wunderlich Christoph |
| collection | DOAJ |
| description | The kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius. |
| first_indexed | 2024-12-22T06:33:36Z |
| format | Article |
| id | doaj.art-2d300353c3c54b4a82fc19dd5fe4dd32 |
| institution | Directory Open Access Journal |
| issn | 2364-5504 |
| language | English |
| last_indexed | 2024-12-22T06:33:36Z |
| publishDate | 2016-09-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj.art-2d300353c3c54b4a82fc19dd5fe4dd322022-12-21T18:35:38ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042016-09-012128929210.1515/cdbme-2016-0064cdbme-2016-0064A method to determine the kink resistance of stents and stent delivery systems according to international standardsBrandt-Wunderlich Christoph0Schwerdt Christopher1Behrens Peter2Grabow Niels3Schmitz Klaus-Peter4Schmidt Wolfram5Institute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyInstitute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyInstitute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyInstitute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyInstitute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyInstitute for Implant Technology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center, Friedrich-Barnewitz-Str. 4, 18119 Rostock-Warnemünde, GermanyThe kink behavior of vascular stents is of particular interest for clinicians, stent manufacturers and regulatory as a kinked stent generates a lumen loss in the stented vessel and can lead to in-stent restenosis. In this study methods to determine the kink resistance of stents and stent delivery systems according to the ISO 25539-2 and FDA guidance no. 1545 were presented. The methods are applicable for balloon expandable stents as well as for self-expanding stents and determine the lumen loss and residual diameter change dependent on the specific bending radius.https://doi.org/10.1515/cdbme-2016-0064delivery systemfdaisokink resistancestandardvascular stents |
| spellingShingle | Brandt-Wunderlich Christoph Schwerdt Christopher Behrens Peter Grabow Niels Schmitz Klaus-Peter Schmidt Wolfram A method to determine the kink resistance of stents and stent delivery systems according to international standards Current Directions in Biomedical Engineering delivery system fda iso kink resistance standard vascular stents |
| title | A method to determine the kink resistance of stents and stent delivery systems according to international standards |
| title_full | A method to determine the kink resistance of stents and stent delivery systems according to international standards |
| title_fullStr | A method to determine the kink resistance of stents and stent delivery systems according to international standards |
| title_full_unstemmed | A method to determine the kink resistance of stents and stent delivery systems according to international standards |
| title_short | A method to determine the kink resistance of stents and stent delivery systems according to international standards |
| title_sort | method to determine the kink resistance of stents and stent delivery systems according to international standards |
| topic | delivery system fda iso kink resistance standard vascular stents |
| url | https://doi.org/10.1515/cdbme-2016-0064 |
| work_keys_str_mv | AT brandtwunderlichchristoph amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schwerdtchristopher amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT behrenspeter amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT grabowniels amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schmitzklauspeter amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schmidtwolfram amethodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT brandtwunderlichchristoph methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schwerdtchristopher methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT behrenspeter methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT grabowniels methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schmitzklauspeter methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards AT schmidtwolfram methodtodeterminethekinkresistanceofstentsandstentdeliverysystemsaccordingtointernationalstandards |