Disrupt CAD Study Design

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Disrupt CAD Study Design Stable angina, unstable angina or silent ischemia Moderate and severely calcified, de novo coronary lesions RVD 2.5 – 4.0 mm, stenosis ≥50%, Lesion length ≤ 32 mm 60 patients enrolled 31 subject OCT sub-study 30 day & 6 months follow-up Core Angiographic & OCT Labs (Yale University & CRF) Objective: To assess the safety and performance of the Lithoplasty® System Primary Safety Endpoint: 30-day MACE (Cardiac death, MI or TVR) Primary Performance Endpoint: Clinical success (residual stenosis <50%) post-PCI with no evidence of in-hospital MACE.

Angiographic Outcomes Cumulative Frequency Distribution Diameter Stenosis 68±13% % 50 Cumulative Frequency % 40 13±11% 30 20 10 Pre Final MLD (mm) 0.9 ± 0.4 2.6 ± 0.5 Acute Gain (mm) NA 1.7 ± 0.6 1 2 Min Lumen Diameter 3 4 Pre-Procedure Final Angiography

Safety Outcomes Freedom from 30-day MACE: 95% Final Angiographic Complications Final N = 60 MACE at 30-‐days 5.0% Cardiac Death 0.0% Non-‐Q-‐wave MI Q-‐wave MI TVR Final N = 60 Residual Dissec@ons 0.0% Perfora@on Abrupt Closure Slow ﬂow No reﬂow Freedom from 6-Months MACE: 91.5% Final N = 59 MACE at 6-‐Months 8.5% (5) Cardiac Death 3.4% (2) Non-Q-wave MI 5.1% (3) Q-wave MI 0.0% TVR Results Angiographic core lab adjudicated & CEC adjudicated

Conclusions Excellent Lithoplasty balloon performance with 100% stent delivery. High acute gain and low residual stenosis by core lab. Low CEC adjudicated 30-day MACE rate of 5.0% with minimal vascular complications. OCT analysis demonstrated heavy calcium burden with substantial luminal acute gain in all groups. Circumferential calcium fracture confirmed mechanim for lithoplasty validated by OCT analysis. The Shockwave Medical Coronary Lithoplasty System is investigational and is not available for sale.