Format

Send to

Choose Destination
Cardiovasc Revasc Med. 2016 Sep;17(6):375-83. doi: 10.1016/j.carrev.2016.05.001. Epub 2016 May 13.

In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond.

Author information

1
Institute for Biomedical Engineering, University Medicine Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: wolfram.schmidt@uni-rostock.de.
2
Institute for Biomedical Engineering, University Medicine Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: peter.behrens@uni-rostock.de.
3
Institute for ImplantTechnology and Biomaterials - IIB e.V., Associated Institute of the University of Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: christoph.brandt@uni-rostock.de.
4
Institute for ImplantTechnology and Biomaterials - IIB e.V., Associated Institute of the University of Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: stefan.siewert@uni-rostock.de.
5
Institute for Biomedical Engineering, University Medicine Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: niels.grabow@uni-rostock.de.
6
Institute for ImplantTechnology and Biomaterials - IIB e.V., Associated Institute of the University of Rostock, Friedrich-Barnewitz-Strasse 4, D-18119 Rostock-Warnemünde, Germany. Electronic address: klaus-peter.schmitz@uni-rostock.de.

Abstract

BACKGROUND/PURPOSE:

Biodegradable polymers are the main materials for coronary scaffolds. Magnesium has been investigated as a potential alternative and was successfully tested in human clinical trials. However, it is still challenging to achieve mechanical parameters comparative to permanent bare metal (BMS) and drug-eluting stents (DES). As such, in vitro tests are required to assess mechanical parameters correlated to the safety and efficacy of the device.

METHODS/MATERIALS:

In vitro bench tests evaluate scaffold profiles, length, deliverability, expansion behavior including acute elastic and time-dependent recoil, bending stiffness and radial strength. The Absorb GT1 (Abbott Vascular, Temecula, CA), DESolve (Elixir Medical Corporation, Sunnyvale, CA) and the Magmaris (BIOTRONIK AG, Bülach, Switzerland) that was previously tested in the BIOSOLVE II study, were tested.

RESULTS:

Crimped profiles were 1.38±0.01mm (Absorb GT1), 1.39±0.01mm (DESolve) and 1.44±0.00mm (Magmaris) enabling 6F compatibility. Trackability was measured depending on stiffness and force transmission (pushability). Acute elastic recoil was measured at free expansion and within a mock vessel, respectively, yielding results of 5.86±0.76 and 5.22±0.38% (Absorb), 7.85±3.45 and 9.42±0.21% (DESolve) and 5.57±0.72 and 4.94±0.31% (Magmaris). Time-dependent recoil (after 1h) was observed for the Absorb and DESolve scaffolds but not for the Magmaris. The self-correcting wall apposition behavior of the DESolve did not prevent time-dependent recoil under vessel loading.

CONCLUSIONS:

The results of the suggested test methods allow assessment of technical feasibility based on objective mechanical data and highlight the main differences between polymeric and metallic bioresorbable scaffolds.

KEYWORDS:

Biodegradable scaffolds; Cardiovascular stenting; Mechanical performance testing

PMID:
27266902
DOI:
10.1016/j.carrev.2016.05.001
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center