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WE TOOK A CRACK
AT SUPERIORITY

The First Level 1 Evidence
in Calcified PAD

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PAD III Data
Summary
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Shockwave IVL Symposium at VIVA20:
Insights from the DISRUPT PAD III RCT in Severe Calcium

Key Findings

  • In the largest-ever randomized clinical trial of severely calcified peripheral lesions, IVL demonstrates superiority over PTA
  • IVL demonstrates a significant reduction in dissections and provisional stenting versus PTA
  • IVL achieves superior vessel preparation vs. PTA with lower pressure, fewer stents, less need for post-dilatation and fewer dissections
  • Disrupt PAD III randomized data confirm the consistent safety and effectiveness of IVL from previous studies in multiple vessel beds
device

In the Largest-Ever Randomized Study of Severely Calcified Peripheral Lesions, IVL Demonstrates Superiority over PTA

306
SFA/Popliteal lesions
randomized to IVL or PTA
83%
Severe calcification by PARC by
an independent core-lab*
129mm
Average calcified length
by an independent core-lab*
*Data refer to IVL arm of randomized study
Primary Endpoint - Site Reported and Angiographic Core Lab Procedure Success Percentage Chart

IVL achieves superior vessel preparation with lower pressure, fewer stents, less need for post-dilatation and fewer dissections

44%
Lower pressure to achieve better results with IVL versus PTA
75%
Reduction in provisional stent placement risk with IVL versus PTA
69%
Reduction in need for post-dilation versus PTA
79%
Reduction in Grade D Dissection with IVL versus PTA

Disrupt PAD randomized data confirm the consistent safety and effectiveness of IVL from previous studies in multiple vessel beds

Diameter Stenosis and Final Angiographic Outcomes Charts

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We're excited about IVL's potential in aortic stenosis, too!

But, right now we're in the early phases of the R&D program. In the meantime, don't miss the IVL application that heart teams are embracing already — maintaining transfemoral TAVR access through heavily calcified iliacs by using IVL.

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