"Patients with heavy calcification have traditionally been excluded from endovascular treatment trials resulting in little available evidence to provide guidance for treating this challenging patient population," said Ehrin J. Armstrong, M.D., Medical Director, Adventist Heart and Vascular Institute, St. Helena, CA. "The Disrupt PAD III OS shows that in common clinical situations that physicians encounter daily, peripheral IVL performs consistently well in a variety of peripheral vessels, lesions and subgroups."

The Disrupt PAD III OS is a prospective, multicenter, single-blind study of "real world" patients, which augments the Disrupt PAD III RCT. The interim analysis looked at results from the first 752 consecutive patients enrolled in the study from November of 2017 to June of 2019 at 18 global sites. Of the 852 lesions treated in the iliac, common femoral, superficial femoral, popliteal and infra-popliteal arteries, 88 percent presented with moderate/severe calcification, with an average calcified length of 127mm. The use of IVL in these lesions resulted in a final residual stenosis of 24 percent, similar to the Disrupt PAD III RCT finding of 22 percent. Patients also experienced minimal procedural complications, with only 0.9 percent and 0.1 percent of patients experiencing final dissections (Type D-F) and perforations, respectively. Notably, there were no instances of embolization, thrombus, no reflow or abrupt closure.

About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.

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