SANTA CLARA, Calif., October 6, 2021 (GLOBE NEWSWIRE) – Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of intravascular lithotripsy (IVL) for the treatment of severely calcified cardiovascular disease, announced today that an interim analysis of the Disrupt PAD III Observational Study (OS) showed that IVL is consistently performing well on demanding peripheral vessels, lesions and patients. The study, which is the largest core angiographic laboratory confirmed “real” evidence of IVL in severely calcified peripheral arteries, was presented today in a recent clinical study session at VIVA21.
The key results of the first 752 patients in the interim analysis of the Disrupt PAD III OS included:
IVL consistently demonstrated 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) thrombotic events at any point in time IVL results were comparable to previously reported results from the randomized clinical trial ( RCT) to Disrupt PAD III, which showed minimal procedural complications and a consistent reduction in the diameter of the stricture, more complex calcified lesions
“Patients with severe calcification have traditionally been excluded from endovascular treatment studies, which provides little available evidence to treat this difficult patient population,” said Ehrin J. Armstrong, MD, medical director, Adventist Heart and Vascular Institute, St. Helena , CA. “The Disrupt PAD III OS shows that peripheral IVL perform consistently well in a variety of peripheral vessels, lesions, and subgroups in common clinical situations that physicians encounter on a daily basis.”
The Disrupt PAD III OS is a prospective, multicenter, single-blind study on patients from the “real world” that complements the Disrupt PAD III RCT. The interim analysis looked at the results of the first 752 consecutive patients enrolled in the study from November 2017 to June 2019 at 18 locations worldwide. Of the 852 lesions treated in the iliac, common femoral, superficial femoral, popliteal, and infrapopliteal arteries, 88 percent had moderate / severe calcification with an average calcified length of 127 mm. Use of IVL on these lesions resulted in final residual stenosis of 24 percent, similar to the Disrupt PAD III RCT finding of 22 percent. The patients also experienced minimal procedural complications, with only 0.9 percent and 0.1 percent of patients suffering a final dissection (type DF) or perforations, respectively. In particular, there were no cases 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; The analysis of the complete data set will be presented in 2022.
About Shockwave Medical, Inc. Shockwave is focused on developing and commercializing products designed to transform the management of calcified cardiovascular disease. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sound pressure waves to treat calcified plaque, which the company calls intravascular lithotripsy (IVL). IVL is a minimally invasive, easy to use and safe method to significantly improve patient outcomes. An animation of the IVL process and further information can be found at www.shockwavemedical.com.
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