News Release Details
Shockwave Medical Enrolls First Patient in Disrupt BTK II Study for Long, Calcified, Below the Knee Lesions
Disrupt BTK II is a post-market, prospective, multicenter, single-arm study led by
“Patients with severely calcified, diffuse below the knee disease, and especially those with critical limb ischemia, are often in severe pain with limited treatment options to achieve adequate arterial revascularization. The unmet clinical need for this population is extremely high,” said
The primary effectiveness endpoint of Disrupt BTK II is procedural success, defined as ≤50 percent residual stenosis for all treated target lesions without serious angiographic complications (flow-limiting dissection, perforation, distal embolization, or acute vessel closure), as assessed by an independent angiographic core lab. The study will assess the absence of major adverse limb events (MALE) within 30 days of the index procedure as a primary safety endpoint.
“More and more patients with CLI also present with end-stage renal disease, advanced diabetes, or other comorbidities that impact their overall health and our ability to effectively treat their CLI,” said
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
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Source: Shockwave Medical, Inc.