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A Stent with Customizable Length for Treatment of Critical Limb Ischemia: Clinical Need, Device Development and Pre-clinical Testing

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Abstract

Critical limb ischemia (CLI) is typically associated with a poor prognosis in the absence of a revascularization treatment. While surgical revascularization can be successful, there is an increasing desire for minimally invasive therapies, particularly in the more distal, infrapopliteal arteries. These small vessels contribute significantly to CLI, especially in diabetic CLI patients. This study describes a unique multi-segmented self-expanding stent developed specifically for use in infrapopliteal revascularization procedures. The number of segments deployed can be selected to optimize the stented length and location. The device may provide an adjunctive treatment in instances of sub-optimal balloon angioplasty when treating CLI. The clinical opportunity for the device is presented, followed by a description of the design and the design process. The results from a range of bench testing are presented as well as the findings of porcine studies to assess in vivo behaviour. In summary, while further development is needed, this study has demonstrated the feasibility of this novel device.

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Acknowledgments

The authors wish to acknowledge the design and development activities of Mr. Brendan Casey and Mr. Ronan Keating. This work has been co-funded by Enterprise Ireland and the European Regional Development Fund (ERDF) through Proof of Concept grant PC-2008-012 and Technology Development grant CFTD-09-0139.

Conflict of interest

Barry O’Brien, Eoin O’Cearbhaill and Mark Bruzzi declare that they have no conflict of interest.

Human Studies

No human studies were carried out by the authors for this article.

Animal Studies

All institutional and national guidelines for the care and use of laboratory animals were followed and approved by the appropriate institutional committees.

Author information

Correspondence to Barry O’Brien.

Additional information

Associate Editor Ajit P. Yoganathan oversaw the review of this article.

Electronic supplementary material

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Supplementary material 1 (WMV 20778 kb)

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O’Brien, B., O’Cearbhaill, E. & Bruzzi, M. A Stent with Customizable Length for Treatment of Critical Limb Ischemia: Clinical Need, Device Development and Pre-clinical Testing. Cardiovasc Eng Tech 5, 317–333 (2014). https://doi.org/10.1007/s13239-014-0192-8

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Keywords

  • Self-expanding
  • Infrapopliteal
  • Angioplasty
  • Multi-segmented
  • Radial force
  • Oversizing