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Disrupt PAD III Observational Arm Confirms IVL Safely and Effectively Modifies Superficial and Deep Calcium in Complex Calcified Lesions
SANTA CLARA, Calif., Oct. 06, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that an interim analysis from the Disrupt PAD III Observational Study (OS) showed that IVL performs consistently well across challenging peripheral vessels, lesions and patients. The study, which is the largest angiographic core lab adjudicated “real world” evidence for IVL in heavily calcified peripheral arteries, was presented earlier today in a late-breaking clinical trial session at VIVA21.
The key findings from the first 752 patients of the Disrupt PAD III OS interim analysis included:
IVL consistently showed its ability to safely and effectively modify superficial and deep calcium across multiple vascular beds, lesion types and in patients with critical limb ischemia (CLI)
IVL resulted in consistent reduction in the diameter of stenosis with no associated distal embolization, abrupt closure or thrombotic events at any time
IVL outcomes were comparable to the previously reported Disrupt PAD III randomized clinical trial (RCT) outcomes showing minimal procedural complications and consistent reduction in diameter stenosis
IVL was successfully used in combination with adjunctive technologies, including specialty balloons and atherectomy, in the treatment of complex calcified lesions
“Patients with heavy calcification have traditionally been excluded from endovascular treatment trials resulting in little available evidence to provide guidance for treating this challenging patient population,” said Ehrin J. Armstrong, M.D., Medical Director, Adventist Heart and Vascular Institute, St. Helena, CA. “The Disrupt PAD III OS shows that in common clinical situations that physicians encounter daily, peripheral IVL performs consistently well in a variety of peripheral vessels, lesions and subgroups.”
The Disrupt PAD III OS is a prospective, multicenter, single-blind study of “real world” patients, which augments the Disrupt PAD III RCT. The interim analysis looked at results from the first 752 consecutive patients enrolled in the study from November of 2017 to June of 2019 at 18 global sites. Of the 852 lesions treated in the iliac, common femoral, superficial femoral, popliteal and infra-popliteal arteries, 88 percent presented with moderate/severe calcification, with an average calcified length of 127mm. The use of IVL in these lesions resulted in a final residual stenosis of 24 percent, similar to the Disrupt PAD III RCT finding of 22 percent. Patients also experienced minimal procedural complications, with only 0.9 percent and 0.1 percent of patients experiencing final dissections (Type D-F) and perforations, respectively. Notably, there were no instances of embolization, thrombus, no reflow or abrupt closure.
The Disrupt PAD III OS completed enrollment in June 2021 with a total of 1,373 patients; analysis of the full data set will be presented in 2022.
About Shockwave Medical, Inc.
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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