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.

For more information: www.shockwavemedical.com

Related Content

MRI May Predict Neurological Outcomes for Cardiac Arrest Survivors
News | Sudden Cardiac Arrest| October 18, 2017
Magnetic resonance imaging (MRI)-based measurements of the functional connections in the brain can help predict long-...
Xarelto Significantly Reduces Major Cardioavascular Events in Stable CAD and PAD Patients
News | Pharmaceuticals| October 18, 2017
October 18, 2017 — Results from the pivotal Phase 3 COMPASS study found that the...
Baylis Medical and Siemens Co-Sponsor Transseptal Access Training Course
News | EP Lab| October 18, 2017
Baylis Medical Co. Inc. and Siemens Healthineers are co-sponsoring a first-of-its kind training program aimed at...
Societies Issue New Performance and Quality Measures for Treating Patients with Heart Attack
News | Cath Lab| October 17, 2017
The American College of Cardiology and the American Heart Association recently released updated clinical performance...
First Patient Enrolled in U.S. Arm of ALIVE Pivotal Heart Failure Trial
News | Heart Failure| October 17, 2017
October 17, 2017 — BioVentrix Inc. recently announced enrollment of the first patient in the U.S.
Medtronic Launches Concerto 3-D Detachable Coil System
News | Embolization devices| October 16, 2017
October 16, 2017 — Medtronic announced the launch of the Concerto 3-D Detachable Coil System at the Cardiovascular an
Dee Dee Wang runs Henry Ford Hospital's 3D printing lab for its complex structural heart cardiology program.

Dee Dee Wang, M.D., runs Henry Ford Hospital's 3-D printing lab that supports its complex structural heart program.

Feature | 3-D Printing| October 13, 2017 | Dave Fornell
Three-dimensional (3-D) printed anatomic models created from a patient’s computed tomography (CT), magnetic resonance...
Low Mortality and Stroke Risks Displayed for Minimally Invasive Aortic Valve Replacements
News | Heart Valve Technology| October 11, 2017
An analysis of more than 1,000 minimally invasive aortic valve replacements and more than 400 additional associated...
New Evaluation Sends Low-Risk ER Chest Pain Patients Home Sooner
News | Cardiac Diagnostics| October 10, 2017
A new evaluation to determine whether emergency room patients with chest pain can go home and follow up with their...
Videos | Chronic Total Occlusion (CTO)| October 09, 2017
Bill Lombardi, M.D., director of complex coronary artery interventions at the University of Washington, discusses the
Overlay Init