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

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.

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

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).

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).

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.