News | Peripheral Artery Disease (PAD) | September 20, 2017

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee

Results demonstrate promise for challenging patient population

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee

September 20, 2017 — Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress, Sept. 16-20 in Copenhagen, Denmark.

“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,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “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.”

DISRUPT BTK, a prospective single-arm clinical study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.

The study enrolled patients with moderate or severe calcified lesions in or below the knee arteries, including 80 percent of patients who were classified as having critical limb ischemia. Acute performance results showed low percent residual stenosis (27 percent) 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.

The Lithoplasty System is a therapy designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.

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, according to Shockwave Medical CEO Doug Godshall.

PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility, potentially leading to surgery or even amputation in patients presenting with critical limb ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty alone with blockages reoccurring in 40 percent of the cases, frequently requiring re-interventions and limb amputation.

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