Shockwave Medical Unveils First One-Year Results of Coronary Intravascular Lithotripsy
New Data at TCT From the Disrupt CAD Clinical Program Demonstrate Consistency of Shockwave IVL Outcomes Over Time, Across Calcium Morphologies and Between Genders
Excerpt from the Press Release:
SANTA CLARA, Calif., Nov. 05, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today unveiled new data confirming the safety and effectiveness of coronary IVL out to one year, a new gender analysis that found similar outcomes between men and women, and an OCT analysis that found consistent acute performance in eccentric, concentric and nodular calcified lesions. The data from the Disrupt CAD clinical program were presented in several sessions at the 32nd Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation, in Orlando, Fla.
First One-Year Outcomes Find Durability of Excellent Procedural Results
The first one-year outcomes from the prospective, multicenter, single-arm, global investigational device exemption (IDE) Disrupt CAD III study demonstrated low rates of major adverse cardiovascular events (MACE, 13.8 percent) and target lesion failure (11.9 percent). The MACE results were primarily driven by the rate of non-Q wave myocardial infarction (9.2 percent), demonstrating durable safety and effectiveness following lesion preparation with IVL prior to stent deployment. The MACE rate included low rates of cardiac death (1.1 percent), myocardial infarction (10.5 percent), and target vessel revascularization (6.0 percent) one year after the index procedure. In addition, target lesion revascularization (TLR), occurred in only 4.3 percent of patients and definite or probable stent thrombosis occurred in 1.1 percent of patients at one year, with only one patient having a definite or probable stent thrombosis beyond 30 days, resulting a late stent thrombosis rate of at 0.3 percent.
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