The WAVE balloon with three inflation cycles increased total number of fragments to 112.6 versus 48.6 with standard balloon single inflation and reduced large fragments >9 mm to 7.6 versus 13.2 (p < 0.001).
Does the WAVE concept increase fragmentation and reduce large fragments in an in vitro model of calcified arterial stenosis compared to standard PTA?
The WAVE balloon concept with multiple shifted inflations significantly increases fragmentation and reduces large fragments in an in vitro calcified stenosis model, suggesting potential for improved angioplasty outcomes.
Estimación del efecto: p < 0.001 (95% CI 112.6 (95% CI [103.3, 121.9]) fragments vs. 48.6 (95% CI [42.5, 54.7]) fragments; fragments >9mm: 7.6 (95% CI [6.4, 8.8]) vs. 13.2 (95% CI [11.6, 14.8]))
Tasa de eventos absoluta: 112.6% vs 48.6%
valor p: 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.
Binkert et al. (Sat,) conducted a other in Calcified arterial lesions in below-the-knee (BTK) arteries modeled in vitro. WAVE balloon with three inflation cycles and slight balloon shift after each inflation (WAVE concept) vs. Standard angioplasty balloon with single inflation cycle (standard PTA) was evaluated on Total number of fragments and number of fragments exceeding 9 mm in length generated by balloon angioplasty (p < 0.001, 95% CI 112.6 (95% CI [103.3, 121.9]) fragments vs. 48.6 (95% CI [42.5, 54.7]) fragments; fragments >9mm: 7.6 (95% CI [6.4, 8.8]) vs. 13.2 (95% CI [11.6, 14.8]), p=<0.001). The WAVE balloon with three inflation cycles increased total number of fragments to 112.6 versus 48.6 with standard balloon single inflation and reduced large fragments >9 mm to 7.6 versus 13.2 (p < 0.001).