Shockwave Medical Launches New Coronary IVL Catheter Internationally, Enrolls First Patient in All-Women Empowerment Study


Shockwave Medical Co., Ltd.

Shockwave Medical Co., Ltd.

Shockwave C2+ Catheter Expands Usefulness of IVL in Calcified Coronary Arteries

SANTA CLARA, Calif., May 15, 2023 (Globe Newswire) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of innovative technologies for the treatment of cardiovascular disease, today announced that it has Announced commercial availability.Shockwave C2+ Coronary intravascular lithotripsy (IVL) catheters for the treatment of severe calcified coronary artery disease in select international markets. Shockwave C2+ Delivers 50% more pulses per catheter than Shockwave C2 Optimally designed to treat longer calcified lesions and more difficult eccentric and nodular calcium.

“Shockwave C”2+ It retains the intuitive catheter design and ease of use that are fundamental to the success of the Shockwave IVL, and incorporates improvements that increase the efficiency of the procedure and optimize treatment for the most challenging forms,” ​​said Royal Brompton Hospital. said Jonathan Hill, M.D., consultant cardiologist at in London. “Extrapulse is most advantageous in areas with the highest calcium load, such as nodular, eccentric, diffusive and multivascular calcium.”

First patient enrolled in EMPOWER CAD

Shockwave Medical also announced the enrollment of its first patient in EMPOWER CAD. This study is the first prospective all-women study of percutaneous coronary intervention aimed at confirming the benefits of coronary IVL in women with calcified lesions who have historically had poor clinical outcomes. be. A male patient undergoing traditional therapy. The first patient was enrolled by Dr. Richard A. Schrofmitz, Chairman of the Department of Cardiology at St. Francis Hospital in Roslyn, New York.

said Margaret Maentegart, M.D., Ph.D., director of the Complex Percutaneous Coronary Interventions Program at Columbia University School of Medicine. After witnessing the first case performed by Dr. Schloftmitz, he became a Co-Principal Investigator at the Center/New York Presbyterian Hospital and EMPOWER CAD. “This is a major step towards a better understanding of the optimal strategy for calcium modification in female patients, who are underrepresented, more difficult to treat and often experience suboptimal outcomes.” patient population.”

The EMPOWER CAD co-Principal Investigators are Margaret Maentegart, M.D., Ph.D., and Alexandra Lansky, M.D., Ph.D., Director of the Cardiovascular Clinical Research Program and Professor of Medicine, Department of Cardiovascular Medicine, Yale University School of Medicine. The European lead for this study is Nieves Gonzalo, M.D., Consultant Interventional Cardiologist, Clinico San Carlos Hospital, Madrid, Spain.

Shockwave C2+ is marketed for the treatment of de novo Coronary artery disease in Europe and some other regions.

About Shockwave Medical

Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first intravascular lithotripsy (IVL) technology transforms the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt difficult calcified plaques, resulting in , significantly improved patient outcomes. Shockwave recently acquired Neovasc Reducer, which is in clinical studies in the US and has his CE Mark in the European Union and UK. Reducer is designed to help millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. For more information, please visit www.shockwavemedical.com and www.neovasc.com.

Forward-Looking Statements
This press release contains statements regarding our expectations, forecasts, beliefs and prospects, which are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, these statements may be identified as forward-looking. “may”, “may”, “would”, “should”, “expect”, “plan”, “anticipate”, “believe”, “estimate”, ” Look for words like “predict”, “likely”, and “continue”. Similar expressions such as ” and their negation. Forward-looking statements in this press release include statements regarding: our ability to successfully execute our business strategies, plans and commercialization strategies; Our expectations for product design. the progress of clinical trials involving our products; You are cautioned not to place undue reliance on these forward-looking statements. Forward-looking statements are projections based on our current expectations, estimates and assumptions, speak only as of the date they are made, and are subject to risks and uncertainties not currently known to us. There is a possibility.

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: inflation, interest rate increases, global the impact of macroeconomic conditions such as banking system instability, market volatility, geopolitical factors (including the ongoing conflict between Russia and Ukraine and its responses to it), supply chain disruptions and our operations; , financial results, liquidity, capital resources, costs, supply chain, residual impact of the COVID-19 pandemic on manufacturing, research and development activities, clinical trials and employees. Ability to successfully execute business and growth strategies. our ability to develop, manufacture, obtain and maintain regulatory approvals, market and sell our products; Ability to obtain compensation and refunds for procedures performed using our products. Ability to expand organizational culture. the impact of competitive product development, regulatory approval, efficacy and commercialization; Loss of key scientists or administrative personnel. Ability to develop and maintain corporate infrastructure, including internal controls. our financial performance and capital requirements; the success of any acquisitions we make; our ability to obtain and maintain intellectual property protection for our products and our ability to operate our business without infringing the intellectual property rights of others; These and other factors are explained in our Securities and Exchange Commission (SEC) filings. This includes the section entitled “Risk Factors” in our most recent annual report on Form 10-K and subsequent quarterly reports. Form 10-Q and other reports filed with the SEC. Except to the extent required by law, we do not undertake to update these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations. .

media contact:
Scott Shadow
+1.317.432.9210
sshadiow@shockwavemedical.com

investor contact:
Debbie Custer
dkaster@shockwavemedical.com



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *