Fremont, Calif. — September 19, 2017 — Shockwave Medical, a pioneer in the treatment of
calcified cardiovascular disease, today reported positive results from the DISRUPT BTK Study,
which were presented at the annual Cardiovascular and Interventional Radiological Society of
Europe (CIRSE) congress in Copenhagen, Denmark.


DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical
Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified
lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and
New Zealand.

“The results of this study are consistent with findings from previous studies of Lithoplasty,
showing a low rate of residual stenosis with minimal complications in a predominantly critical
limb ischemic patient population,” said Marianne Brodmann, M.D., of the Medical University of
Graz, Austria. “These results suggest that the Lithoplasty treatment has the potential to address
challenges that calcified stenosis pose below the knee, where calcium is more prevalent and
different than above the knee. It can occur deeper in the artery wall, making these lesions more
difficult to treat. Treatment failure can pose heightened risks for patients with critical limb
ischemia, including higher risks of amputation and death.”

The study enrolled patients with moderate or severe calcified lesions in below the knee arteries,
including 80% of patients who were classified as having critical limb ischemia. Acute
performance results showed low percent residual stenosis (27%) with low vascular
complications, including no perforations, distal embolization, reflow complications or abrupt
closure and only one grade B dissection. There were no major adverse events including death,
myocardial infarction, target limb revascularization or amputation through 30 days.

The Lithoplasty System is an innovative therapy designed to treat calcified leg artery blockages
with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The
technology is now commercially available in both the United States and Europe for the
treatment of calcified plaque in peripheral arteries.

“Interventional procedures that involve moderate and severe calcium can be complex,
unpredictable and costly. The previous DISRUPT PAD Study demonstrated that Lithoplasty
addresses many major concerns in the treatment of problematic calcium in femoral and popliteal

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