Enrollment Begins in DISRUPT PAD III Study of Shockwave Medical's Lithoplasty Technology

April 5, 2017—PinnacleHealth Cardiovascular Institute in Harrisburg, Pennsylvania, announced that the first patient in the United States was enrolled in the DISRUPT PAD III multicenter, randomized trial assessing the safety and effectiveness of Shockwave Medical's Lithoplasty system in patients with calcified peripheral artery disease (PAD). In November 2016, Shockwave Medical announced the plans for the DISRUPT PAD III trial, which involves femoropopliteal lesions.

As noted in the PinnacleHealth press release, the aim of the trial is to assess the optimal therapy to dilate heavily calcified lesions by comparing the Shockwave Lithoplasty system versus traditional angioplasty, with a primary goal of achieving < 30% residual stenosis without the need for stenting. In the trial, all patients who do not receive a stent will be treated with a drug-coated balloon. The trial will enroll 334 patients in up to 45 global sites.

William Bachinsky, MD, Medical Director of Vascular Services at PinnacleHealth Cardiovascular Institute, serves as principal investigator at PinnacleHealth. In the announcement, Dr. Bachinsky commented, "We are very excited to be the first to treat a United States patient in the global study of this cutting-edge technology for patients with claudication or pain in the legs due to leg artery blockages. The Shockwave Medical Lithoplasty device, if proven because of this clinical trial, will be a game changer in the treatment of patients with PAD, allowing for low pressure, controlled expansion of blocked artery, and potentially less risk for internal tearing of the artery and need for implanting permanent metal stents."

As explained in the PinnacleHealth announcement, the Lithoplasty technology delivers localized lithotripsy for the treatment of calcified arteries in patients with PAD. Built on an angioplasty balloon platform, each catheter incorporates multiple lithotripsy emitters activated with the touch of a button while the integrated balloon inflates. When activated, the emitters produce therapeutic sound waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque by creating a series of microfractures. After the calcium has been disrupted, the vessel can be effectively dilated using low pressures thereby enabling even historically challenging PAD patients to be treated effectively and with minimal injury to the vessel.