Shockwave Medical Introduces Enhanced Coronary IVL Catheter in the United States

2023-10-20

上市批准AHA会议

Shockwave C2+ Debut Joins Packed Shockwave Agenda at Transcatheter Cardiovascular Therapeutics Conference in San Francisco SANTA CLARA, Calif., Oct. 20, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, announced today the planned U.S. introduction of the Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) catheter following approval by the U.S. Food and Drug Administration. The Shockwave C2+ catheter provides 50 percent more pulses per catheter than the Shockwave C2 catheter that was approved in the U.S. in 2021. The enhanced C2+ catheter will make its U.S. debut at the 35th Transcatheter Cardiovascular Therapeutics (TCT) annual scientific symposium of the Cardiovascular Research Foundation, with the full commercial launch planned for the beginning of November. “The enhancements of Shockwave C2+ will be an added benefit of IVL for optimally treating complex calcium, including more diffuse disease, as well as nodular and thick, eccentric calcium,” said Richard Shlofmitz, MD, Chairman, Department of Cardiology, St. Francis Hospital in Roslyn, New York, who performed the first U.S. commercial case with Shockwave C2+. “When additional pulses are added to the existing intuitive catheter design and simple-to-use system that are foundational to the success of Shockwave IVL, the result is an updated catheter that can enhance workflow and improve procedural efficiency.” TCT23 to Feature New Coronary IVL Data and Insights and Symposia on COSIRA-II The following scientific sessions and symposia supporting Shockwave Medical’s growing portfolio of technologies and clinical studies will be taking place at TCT: Monday, October 23, 2023 TCT WorldLink Latin America Featured Clinical Science: Complex Coronary Intervention Presentation Title: Shock India Registry: Multicenter Registry of Coronary IVL in Calcified Coronary Arteries in Real-World Indian Patient Population Time and Location: 10:30 AM – 10:41 AM; Presentation Theater 3, Room 215, Level 2, Moscone South Presenter: Prof. Ashok Seth, MBBS*, Fortis Escorts Heart Institute & Research Centre Tuesday, October 24, 2023 Shockwave Medical Sponsored Symposia Presentation Title: The COSIRA-II Trial: Designed To Demonstrate Refractory Angina Relief with the Coronary Sinus Reducer Time and Location: 2:00 PM – 3:00 PM, Presentation Theater 1, Room 205, Level 2, Moscone South Presenters: Gregg W. Stone, MD, Mount Sinai Heart Health System; Allen Jeremias, MD*, St. Francis Hospital; Timothy D. Henry, MD, The Christ Hospital; Prof. Stefan Verheye*, ZNA Middelheim Hospital; Megha Prasad, MD, New York-Presbyterian Columbia University Irving Medical Center Wednesday, October 25, 2023 Shockwave Medical Sponsored Symposia Presentation Title: TOPSHOCK: Vote for this Year’s Best Coronary IVL Case Time and Location: 11:00 AM – 12:00 PM, Presentation Theater 1, Room 205, Level 2, Moscone South Presenters: Prof. James C. Spratt, MD*, St. George's University Hospitals NHS Trust; Ziad Ali, MD*, St. Francis Hospital; Kalaivani Mahadevan, MD*, Portsmouth Hospitals University NHS Trust; Tim O’Connor, MD*, Beaumont Hospital; Sameh Sayfo, MD*, Baylor Scott & White, The Heart Hospital Thursday, October 26, 2023 Coronary Spotlight Session: Calcium – How Hard Should We Try? Presentation Title: Coronary IVL in the US: Trends, Hospital Variation, & Predictors of Use: Insights From the ACC NCDR CathPCI Registry Time and Location: 10:42 AM – 10:50 AM, Coronary Spotlight Theater, Hall E, Exhibition Level, Moscone North Presenter: Neel Butala, MD*, UCHealth University of Colorado Hospital Shockwave Medical Sponsored Symposia Presentation Title: Coronary IVL: More Pulses, More Data, More Insights Time and Location: 12:45 PM – 1:45 PM, Presentation Theater 2, Room 208, Level 2, Moscone South Presenters: Yousif Ahmad, M.D.*, Yale Medicine; Neel Butala, MD*, UCHealth University of Colorado Hospital; Prof. Ashok Seth, MBBS*, Fortis Escorts Heart Institute & Research Centre; Prof. Gennaro Sardella, MD*, Presso Policlinico Umberto; Ziad Ali, MD*, St. Francis Hospital; Darshan Doshi, MD*, Massachusetts General Hospital A detailed agenda for all Shockwave Medical symposia and featured presentations can be found here. Shockwave C2+ is commercially available for the treatment of de novo coronary artery disease in the United States, Europe and select other geographies. About Shockwave Medical, Inc. Shockwave Medical is a leader in the development and commercialization of innovative products that are transforming the treatment of cardiovascular disease. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Shockwave has also recently acquired the Neovasc Reducer, which is under clinical investigation in the United States and Canada, and is CE Marked in the Europe. By redistributing blood flow within the heart, the Reducer is designed to provide relief to the millions of patients worldwide suffering from refractory angina. Learn more at and . About Reducer While under clinical investigation in the COSIRA-II trial (U.S. and Canada), the Reducer is CE-marked for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure. 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These factors, as well as others, are discussed in our filings with the Securities and Exchange Commission (SEC), including in the sections titled “Risk Factors” in our most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in our other reports filed with the SEC. Except to the extent required by law, we do not undertake to update any of these forward-looking statements after the date hereof to conform these statements to actual results or revised expectations. Media Contact: Scott Shadiow +1.317.432.9210 sshadiow@shockwavemedical.com Investor Contact: Debbie Kaster dkaster@shockwavemedical.com *Physicians are paid consultants of Shockwave Medical.