Shockwave Medical reported results from a 20-patient study showing its ultrasound balloon for the treatment of peripheral artery disease was effective in patients with arterial blockage below the knee.
The company’s Peripheral Lithoplasty System combines traditional balloon angioplasty with lithotripsy, the use of ultrasound waves generally used to break up kidney stones. It works by delivering ultrasound shockwaves to break up calcified plaques in the arteries, while the balloon restores blood flow.
The device is FDA-cleared for the treatment of PAD in arteries of the lower abdomen, including the renal and iliac arteries, and in the legs, including the popliteal arteries in the knee. It is not approved for use in arteries below the knee.
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The new study enrolled 20 patients with moderate or severe calcified lesions in arteries below the knee, the company said in a statement. Of the 20, 16 (80%) of them had critical limb ischemia—severe blockage of the arteries that limits blood flow to the extremities and can cause significant pain and skin ulcers.
The data showed a low percentage of residual stenosis (27%), and posted a low rate of vascular complications and no major adverse events through 30 days, Shockwave said.
“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,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria, in the statement. “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.”