Clinical Research Studies

The study involves a medical device called the Shockwave Medical Peripheral Intravascular Lithotripsy System, also referred to as the Shockwave Peripheral IVL System. The FDA has cleared this device for sale in the United States based on a determination that it is substantially equivalent (very similar) to a device that is already on the market. The purpose of this study is to test whether it is safe and effective in treating peripheral artery disease in arteries below the knee.

The types of balloons being studied in this clinical study are similar to other balloon devices that are routinely used in angioplasty procedures; however, IVL balloons have a unique technology inside the balloon that is designed to deliver sonic energy (sound) to break up the hard, calcified elements of vascular blockages. With the balloon inflated at a low pressure, the probe will be activated to break up the calcium that is restricting the expansion of the artery.