News Release Details
Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status
The updated guidelines, which modify the previous 2014 guidelines by no longer restricting recommended treatment to facilities with on-site surgical backup, will now endorse expanded treatment options and access for patients with calcified coronary lesions.
“When a lesion is more heavily calcified than is readily apparent on angiography, it is critical to have a strategy to safely and immediately modify the calcium to be able to successfully proceed with the case,” said Dr.
“Now, with IVL we have a tool that can safely modify severely calcified lesions, but that does not have the associated risk that requires onsite surgical backup. IVL has allowed us to streamline patient care while providing the best possible outcomes for these patients – it is a win for physicians, the system and for the patients,” continued
The 2014 guidelines recommended avoiding treatment of high-risk lesions defined as “more than moderate calcification” in facilities without surgical backup. The updated guidelines note the old recommendation “restricted practice, limited patient choice and exposed interventional cardiologists to legal risk.”
“With the interventional field rapidly evolving, we commend SCAI for continuously evaluating current interventional practices to ensure that their consensus documents accurately provide the best possible guidance for optimal patient care,” 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.
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, 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.