Shockwave Medical today released results from the Disrupt below the knee study of its Shockwave Lithoplasty system designed to treat peripheral artery disease, touting low rates of residual stenosis and low vascular complications.
Data from the study was presented at the annual Cardiovascular and Interventional Radiological Society of Europe congress in Copenhagen, Denmark.
“Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous Disrupt PAD Study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in femoral and popliteal artery lesions, achieving a high acute gain in vessel diameter with minimal dissections, embolization, perforation or recoil. 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,” CEO Doug Godshall said in a press release.
The 20-patient study aimed to examine the use of the Shockwave Lithoplasty system as a treatment for PAD in patients with calcified lesions in arteries below the knee. Patients enrolled in the study had moderate or severe calcified lesions in below the knee arteries with 80% of patients classified as having critical limb ischemia.
Results from the study indicated a 27% rate of residual stenosis with no perforations, distal embolization, reflow complications or abrupt closures and a single grade B dissection. No major adverse events were reported through 30 days.
“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 ischemic 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,” Dr. Marianne Brodmann of Austria’s Medical University of Graz said in a prepared statement.
In May, Shockwave Medical said it won CE Mark approval in the European Union for its coronary Lithoplasty system. The therapy is designed to treat calcified coronary artery blockages with lithotripsy – sonic pressure waves that are traditionally used to treat patients with kidney stones.