Shockwave Medical, Inc.

The Shockwave study aims to confirm the benefits of coronary intravascular lithotripsy (IVL) in women. Co-principal investigator Dr. Margaret McEntegart, director of Complex PCI and CTO programs at Columbia University Medical Center/NewYork-Presbyterian Hospital, completed the final enrollment during a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. The study, which includes 400 participants across 48 sites in five countries, is set to release primary endpoint results in 2025, with continued patient follow-up through three years. “The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions,” said McEntegart. “Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients.” Women comprise about a quarter of cardiovascular clinical trial participants, limiting gender-specific data essential for treatment advancements. Female patients undergoing PCI face a higher risk of procedural complications, emphasizing the need for targeted studies. “We are eager to analyze the data and share results next year, with a goal of helping to close the gap in treatment outcomes between men and women,” said Alexandra Lansky, Professor of Medicine, section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine and co-principal investigator of EMPOWER CAD. “EMPOWER represents a significant step forward in women’s heart health. We also look forward to seeing the participating female interventional cardiologists and clinical researchers in the study continue to take on clinical trial leadership roles in the years to come.” Most notably, 71% of enrolling sites are led by female principal investigators. “We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care,” Shockwave Medical Chief Medical Officer Nick West said. “This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”

据外媒Endpoints 9月25日报道，强生正在逐步关闭其制药部门的心血管和代谢部门，该举动主要影响销售、营销和医学事务团队。 这是强生继去年关闭传染病和疫苗部门后的第二次大规模重组。本次重组主要影响心血管部门的商业工作，而非研发。这一变化促使强生在全球范围内裁员，并剥离了许多疫苗和预防项目。 心血管和代谢部门的核心产品是拜瑞妥（利伐沙班），这是强生与拜耳合作开发的抗凝药，曾是世界上最畅销的药物之一。但由于美国政府的医疗保险价格谈判，拜瑞妥的价格降低了62%。 强生的医疗器械部门在心血管领域的业务未受影响，仍在积极进行相关收购和研发活动： 今年8月份，强生将以6亿美元的预付款收购V-Wave。 今年4月，强生份以131亿美元现金收购Shockwave所有流通股，该公司专注于开发钙化心血管疾病治疗的产品，并全球首推产品“冲击波球囊导管”。 2022年，强生公司以166亿美元收购了医疗设备制造商Abiomed。该公司的王牌产品为Impella心脏泵。 2023年9月，强生宣布品牌焕新，将旗下医疗科技和制药两大业务整合至强生（Johnson & Johnson）名下。其中，制药业务杨森更名为强生创新制药（Johnson & Johnson Innovative Medicine）。这家制药公司一直淡化其心血管和代谢业务，将研发重点缩小到三个治疗领域：肿瘤学、免疫学和神经科学。 强生在2024年进行了多项收购和研发活动，包括收购Proteologix获得免疫学双抗资产、收购Numab获得IL-4R/IL-31双抗、收购Ambrx开发下一代ADC产品等。公司发言人表示，这是强生在复杂和快速变化的外部环境中适应和发展业务的必要举措。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。 转载/商务/投稿 | 联系微信 wfj_GM 商务合作 稿件征集 点击了解详情 往期回顾 1 5月| 20家药企裁员（附名单） 2 18亿美元，ADC又出海! 宜联生物宣布新授权 3 2024 ASCO| 默沙东/科伦TROP2 ADC、信达、礼新CLDN18.2 ADC数据公布

Shockwave E8 Augments IVL's Capabilities for Physicians Treating Peripheral Arterial Disease Above and Below the Knee SANTA CLARA, Calif., Sept. 16, 2024 /PRNewswire/ -- Shockwave Medical, Inc., part of Johnson & Johnson MedTech* and a global leader in the field of circulatory restoration, announced the full U.S. launch of the Shockwave E8 Peripheral IVL Catheter, following clearance by the U.S. Food and Drug Administration (FDA). The Shockwave E8 catheter is designed to optimize the treatment of patients with calcified femoro-popliteal and below-the-knee peripheral artery disease (PAD), including patients with complex chronic limb-threatening ischemia (CLTI). Continue Reading Shockwave E8 Peripheral IVL Catheter PAD affects more than eight million people aged 40 and older in the United States.1 People suffering from PAD have not only impaired quality of life but also increased risk of heart attack or stroke.2 CLTI is the most advanced and serious form of PAD, impacting nearly 2 million patients in the U.S. It is associated with 40% major amputations at 1 year, and a 50% mortality rate at 5 years,3 worse than most forms of cancer. "Shockwave's newest peripheral catheter offers significant improvements that will help physicians refine their treatment algorithm and better support challenging patients with heavily calcified disease," said Venita Chandra†, M.D., Vascular Surgeon and Clinical Associate Professor, Division of Vascular Surgery, Stanford Health Care. "The catheter's ability to treat long lesions and its extended reach enable safe and effective treatment of some of our most difficult-to-treat patients, including those with CLTI, a complicated and severe disease state with a high mortality rate." With four hundred pulses delivered twice per second, and eight emitters across an 80cm balloon, Shockwave E8 can treat longer lesions more efficiently. With an increased catheter working length of 150cm, physicians can extend their IVL treatment to reach below-the-knee and very distal lesions. Combined with Shockwave L6, Shockwave M5+, and Shockwave S4 IVL catheters, the addition of Shockwave E8 offers physicians a complete IVL portfolio to treat challenging calcified lesions across the entire peripheral anatomy. "Shockwave E8 represents our commitment to physician-guided innovation while maintaining the simplicity and effectiveness of our IVL technology," said Isaac Zacharias, President, Shockwave Medical. "We have received very positive physician feedback on Shockwave E8 and look forward to establishing it as our new workhorse peripheral IVL catheter for physicians addressing challenging calcium above and below the knee." About Shockwave Medical Shockwave Medical, part of Johnson & Johnson MedTech, 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 using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to the millions of patients worldwide suffering from refractory angina by redistributing blood flow within the heart. Learn more at . About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more about our MedTech sector's global scale and deep expertise in cardiovascular, orthopaedics, surgery and vision solutions at . Follow us at @JNJMedTech and on LinkedIn. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding the Shockwave E8 catheter. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Shockwave Medical, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward healthcare cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. Neither Shockwave Medical, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. * Comprising the surgery, orthopaedics, vision, and cardiovascular businesses within Johnson & Johnson's MedTech segment. † Dr. Chandra is a paid consultant for Shockwave Medical. She has not been compensated in connection with this press release. 1 2 3 Media Ryan Carbain [email protected] Investors Tracy Menkowski [email protected] SOURCE Johnson & Johnson MedTech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED