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Shockwave Medical reports positive results from first study of Lithoplasty System in calcified lesions below the knee

Press releases may be edited for formatting or style | September 21, 2017 Cardiology Heart Disease
artery lesions, achieving a high acute gain in vessel diameter with minimal dissections,
embolization, perforation or recoil,” said Doug Godshall, CEO of Shockwave Medical.

“DISRUPT BTK now gives clinicians encouraging data in a high risk patient population where
calcific lesions pose different treatment challenges including the potential for limb loss.”
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PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility,
potentially leading to surgery or even amputation in patients presenting with critical limb
ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium
within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the
artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly
used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty
alone with blockages reoccurring in 40 percent of the cases, frequently requiring reinterventions
and limb amputation.

About Shockwave Medical’s Lithoplasty System

Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with
the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty
catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the
integrated balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure
waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue,
preferentially disrupting the calcified plaque inside the vessel wall by creating a series of microfractures.
When the calcium has been modified, the vessel can be dilated using low pressures,
thereby enabling even historically challenging PAD patients to be treated effectively with
minimal injury to the vessel.

The Peripheral Lithoplasty System is commercially available in both the United States and
Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified
lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infrapopliteal,
and renal arteries. Not for use in the coronary or cerebral vasculature.

The devices used in the DISRUPT BTK study are not available or approved for sale in the
United States.

To view an animation of the Lithoplasty System visit http://shockwavemedical.com.

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