PAD III

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PAD III Data Summary

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Disrupt PAD III is the largest-ever randomized study of severely calcified peripheral lesions

45

Global sites

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 refers to IVL arm of randomized study

SUPERIOR PREP

IVL’s unique mechanism of action delivers significantly more luminal gain with lower dilatation pressure and less need for post-dilatation

Superior Procedural Success

Procedural Success = Residual stenosis ≤30% without flow‑limiting dissections prior to DCB +/- stenting

Atraumatic Treatment

PRESERVED OPTIONS

IVL maintains control of the procedure by minimizing complications such as dissections, embolization, and perforations. IVL significantly reduces the need for bailout stents, preserving future treatment options.

Reduced Dissections

Low Complications

0% embolization, perforation, thrombus, and no flow

Reduced Bailout Stenting

IVL 75% reduction in bailout stenting bar graph

Embolic protection: Utilized in 1.3% of cases in IVL treatment arm.

Provisional stent: Utilized if residual stenosis ≥50% by visual estimate or unresolved ≥ type D dissection, and trans-lesional gradient > 10 mmHg

EXCELLENT LONG-TERM RESULTS

IVL has demonstrated excellent patency out to two years in a severely calcified patient population

Primary Patency^*

^*Primary Patency defined as freedom from provisional stenting at index procedure, freedom from clinically-driven target lesion revascularization, and freedom from restenosis determined by duplex ultrasound