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Background <p>Standard percutaneous transluminal angioplasty (PTA) occasionally falls short in sufficiently treating calcified lesions in below the knee arteries.</p> <p>To address this, a new balloon design, called WAVE, was developed. This balloon is divided into multiple smaller segments, thereby creating a segment-waist shaped stress pattern. In combination with a procedural adjustment, involving three inflation cycles and a slight shift of the balloon between each inflation, the WAVE concept is proposed, in which enhanced fragmentation of calcified lesions is hypothesized.</p> Purpose <p>A comparison between the standard of care PTA and the WAVE concept was made to evaluate the potential benefit of implementing the WAVE concept.</p> Materials and methods <p>The experiment was evaluated using a calcified arterial in vitro model. The primary endpoint was to assess and compare both the total number of fragments and the number of fragments larger than 9&#xa0;mm generated by the WAVE concept (including three inflations) versus the standard PTA (standard balloon with a single inflation).</p> Results <p>The WAVE concept generated a significantly higher total number of fragments (112.6; 95% CI [103.3, 121.9]) compared to the standard balloon after a single inflation (48.6; 95% CI [42.5, 54.7]) (<i>p</i> &lt; 0.001). The number of fragments exceeding 9&#xa0;mm was significantly lower with the WAVE concept (7.6; 95% CI [6.4, 8.8]) compared to standard PTA (13.2; 95% CI [11.6, 14.8]) (<i>p</i> &lt; 0.001).</p> Conclusion <p>The WAVE concept creates more and smaller fragments in a below-the-knee calcified arterial in vitro model. These findings show promising potential to improve the outcomes of future angioplasty procedures.</p>

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In vitro evaluation of a new balloon design to treat calcified stenosis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月28日

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  • Oliver Andrew Binkert,
  • Christoph Andreas Binkert,
  • Thomas Frauenfelder

摘要

Background

Standard percutaneous transluminal angioplasty (PTA) occasionally falls short in sufficiently treating calcified lesions in below the knee arteries.

To address this, a new balloon design, called WAVE, was developed. This balloon is divided into multiple smaller segments, thereby creating a segment-waist shaped stress pattern. In combination with a procedural adjustment, involving three inflation cycles and a slight shift of the balloon between each inflation, the WAVE concept is proposed, in which enhanced fragmentation of calcified lesions is hypothesized.

Purpose

A comparison between the standard of care PTA and the WAVE concept was made to evaluate the potential benefit of implementing the WAVE concept.

Materials and methods

The experiment was evaluated using a calcified arterial in vitro model. The primary endpoint was to assess and compare both the total number of fragments and the number of fragments larger than 9 mm generated by the WAVE concept (including three inflations) versus the standard PTA (standard balloon with a single inflation).

Results

The WAVE concept generated a significantly higher total number of fragments (112.6; 95% CI [103.3, 121.9]) compared to the standard balloon after a single inflation (48.6; 95% CI [42.5, 54.7]) (p < 0.001). The number of fragments exceeding 9 mm was significantly lower with the WAVE concept (7.6; 95% CI [6.4, 8.8]) compared to standard PTA (13.2; 95% CI [11.6, 14.8]) (p < 0.001).

Conclusion

The WAVE concept creates more and smaller fragments in a below-the-knee calcified arterial in vitro model. These findings show promising potential to improve the outcomes of future angioplasty procedures.