DISRUPT BTK Results Reported for Shockwave Medical's Lithoplasty System
September 19, 2017—Shockwave Medical announced that results from the DISRUPT BTK study were presented at CIRSE 2017, the annual congress of the Cardiovascular and Interventional Radiological Society of Europe held September 16–20 in Copenhagen, Denmark.
DISRUPT BTK is a prospective single-arm study evaluating the use of Shockwave Medical's Lithoplasty system as a treatment for peripheral artery disease in patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.
According to the company, 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 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.
In the Shockwave Medical's announcement, principal investigator Marianne Brodmann, MD, commented, “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 ischemia patient population. 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 company advised that the devices used in the DISRUPT BTK study are not available or approved for sale in the United States.
According to Shockwave Medical, the Lithoplasty system is designed to treat calcified leg artery blockages with lithotripsy, which are sonic pressure waves historically used to treat patients with kidney stones.