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

作者：O' Brien Barry; O' Cearbhaill Eoin; Bruzzi Mark

来源：Cardiovascular Engineering and Technology, 2014, 5(4): 317-333.

DOI：10.1007/s13239-014-0192-8

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

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 multisegmented 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.

• 出版日期2014-12