Evaluation of Magnesium-based Medical Devices in Preclinical Studies: Challenges and Points to Consider

Toxicol Pathol. 2019 Apr;47(3):390-400. doi: 10.1177/0192623318816936. Epub 2019 Feb 3.

Abstract

Absorbable metallic implants have been under investigation for more than a century. Animal and human studies have shown that magnesium (Mg) alloys can be safely used in bioresorbable scaffolds. Several cardiovascular and orthopedic biodegradable metallic devices have recently been approved for use in humans. Bioresorbable Mg implants present many advantages when compared to bioabsorbable polymer or nonabsorbable metallic implants, including similar strength and mechanical properties as existing implant-grade metals without the drawbacks of permanence or need for implant removal. Imaging visibility is also improved compared to polymeric devices. Additionally, with Mg-based cardiovascular stents, the risk of late stent thrombosis and need for long-term anti-platelet therapy may be reduced as the host tissue absorbs the Mg degradation products and the morphology of the vessel returns to a near-normal state. Absorbable Mg implants present challenges in the conduct of preclinical animal studies and interpretation of pathology data due to their particular degradation process associated with gas production and release of by-products. This article will review the different uses of Mg implants, the Mg alloys, the distinctive degradation features of Mg, and the challenges confronting pathologists at tissue collection, fixation, imaging, slide preparation, evaluation, and interpretation of Mg implants.

Keywords: bioresorbable; implant; magnesium; medical devices; safety assessment.

Publication types

  • Review

MeSH terms

  • Alloys / adverse effects*
  • Alloys / chemistry
  • Animals
  • Biocompatible Materials / adverse effects*
  • Biocompatible Materials / standards
  • Equipment Safety / instrumentation
  • Equipment Safety / methods*
  • Imaging, Three-Dimensional
  • Magnesium / adverse effects*
  • Magnesium / chemistry
  • Materials Testing / instrumentation
  • Materials Testing / methods*
  • Prostheses and Implants / adverse effects*
  • Prostheses and Implants / standards

Substances

  • Alloys
  • Biocompatible Materials
  • Magnesium