News Release Details
Shockwave IVL Maintains Superiority to Angioplasty in Calcified Peripheral Disease at Two Years
As previously published, IVL at 30 days demonstrated superiority over PTA in the primary endpoint analysis, defined as procedural success with a residual stenosis less than or equal to 30 percent without flow-limiting dissection, prior to drug-coated balloon (DCB) or stent, with a rate of 65.8 percent versus 50.4 percent (p=0.0065) as determined by an independent angiographic core lab. Additionally, PAD III showed that IVL achieved a reduction in frequency and severity of flow-limiting major dissections (1.4 percent vs. 6.8 percent, p=0.03), a reduction in stent implantation rate (4.6 percent vs 18.3 percent, p<0.001) and no distal embolization or perforation events.
These new long-term results found that the powered secondary endpoint of primary patency (defined as freedom from CD-TLR, restenosis determined by duplex ultrasound and provisional stenting) favored IVL over PTA at one year (80.5 percent vs. 68.0%, p=0.017) and remained favorable through two years (Kaplan-Meier estimate: 74.4 percent vs. 57.7 percent, p=0.005), respectively.
“Prior to the PAD III study, there were limited long-term data available to provide treatment guidance for this challenging population since patients with severe calcification have historically been excluded from endovascular trials,” said
Disrupt PAD III was a prospective, multicenter, randomized study designed to demonstrate the safety and effectiveness of IVL as a vessel preparation procedure in moderate to severely calcified superficial femoral and popliteal lesions, followed by a DCB or stent. The study enrolled 306 patients randomized between IVL and PTA at 45 sites in
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.
This press release contains statements relating to our expectations, projections, beliefs, and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” and similar expressions, and the negative of these terms. You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are only predictions based on our current expectations, estimates, and assumptions, valid only as of the date they are made, and subject to risks and uncertainties, some of which we are not currently aware.
Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: the impact of the COVID-19 pandemic on our operations, financial results, and liquidity and capital resources, including the impact on our sales, expenses, supply chain, manufacturing, research and development activities, clinical trials, and employees; our ability to develop, manufacture, obtain and maintain regulatory approvals for, and market and sell our products; our expected future growth, including the size and growth potential of the markets for our products; our ability to obtain coverage and reimbursement for procedures performed using our products; our ability to scale our organizational culture; the impact of the development, regulatory approval, efficacy and commercialization of competing products; the loss of key scientific or management personnel; our ability to develop and maintain our corporate infrastructure, including our internal controls; our financial performance and capital requirements; and our ability to obtain and maintain intellectual property protection for our products, as well as our ability to operate our business without infringing the intellectual property rights of others. These factors, as well as others, are discussed in our filings with the
Source: Shockwave Medical, Inc.