Latest news with #EuroPCR
Malaysian Reserve
22-05-2025
- Health
- Malaysian Reserve
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year PARIS, May 22, 2025 /PRNewswire/ — Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION1 Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR. The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year. During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm. 'The CathWorks FFRangio® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care,' said Ramin Mousavi, CathWorks President & CEO. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit and follow @CathWorks on LinkedIn. 1. Prospective Randomized trial of clinical Outcomes of angiography-based fractional flow reserve guidance Versus wIre-baSed fractIOnal flow reserve guidance (PROVISION) study is an investigation of the Utility of Coronary Angiography (FFRangio) in Comparison to Coronary Fractional Flow Reserve (FFR) in the Determination of Treatment Planning and the Clinical Prognosis in Patients with Chronic Phase Coronary Artery Disease Investors:Mike Media:Sarita Photo – – View original content:
Yahoo
22-05-2025
- Health
- Yahoo
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year PARIS, May 22, 2025 /PRNewswire/ -- Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION1 Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR. The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year. During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm. "The CathWorks FFRangio® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care," said Ramin Mousavi, CathWorks President & CEO. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit and follow @CathWorks on LinkedIn. 1. Prospective Randomized trial of clinical Outcomes of angiography-based fractional flow reserve guidance Versus wIre-baSed fractIOnal flow reserve guidance (PROVISION) study is an investigation of the Utility of Coronary Angiography (FFRangio) in Comparison to Coronary Fractional Flow Reserve (FFR) in the Determination of Treatment Planning and the Clinical Prognosis in Patients with Chronic Phase Coronary Artery Disease Investors:Mike Media:Sarita View original content to download multimedia: SOURCE CathWorks
Cision Canada
22-05-2025
- Health
- Cision Canada
PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR
PARIS, May 22, 2025 /CNW/ -- Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION 1 Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR. The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year. During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm. "The CathWorks FFRangio ® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care," said Ramin Mousavi, CathWorks President & CEO. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio ® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit and follow @CathWorks on LinkedIn. Investors: Mike Feher [email protected] Media: Sarita Monico [email protected]
Yahoo
20-05-2025
- Health
- Yahoo
Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025
EMPOWER CAD, a global prospective, multi-center, real-world study, reaffirms favorable acute outcomes for coronary IVL in female patients, unlike other calcium modification tools PARIS, May 20, 2025 /PRNewswire/ -- Shockwave Medical, Inc., part of Johnson & Johnson MedTech and a global leader in the field of circulatory restoration, announced today the 30-day primary endpoint results of EMPOWER CAD, the first prospective, real-world percutaneous coronary intervention (PCI) study in female patients with complex, calcified coronary artery disease. The favorable results confirm the results of earlier retrospective analyses demonstrating the benefits of coronary intravascular lithotripsy (IVL) in female patients. The results were presented in a late-breaking presentation at the annual EuroPCR meeting in Paris. Women with coronary artery calcification (CAC) undergoing PCI are often underrepresented in clinical trials and have historically poorer outcomes than men, including increased risk of adverse clinical outcomes and high rates of procedural complications with other calcium modification treatments, such as rotational or orbital atherectomy.1,2 Investigators designed the EMPOWER CAD study to evaluate real-world outcomes in female patients with severely calcified coronary lesions treated with an IVL-first treatment strategy and confirm positive results from previous studies showing similar safety and effectiveness outcomes across both men and women. EMPOWER CAD is a pivotal study comprised of a series of firsts: Shockwave's first prospective, post-market study of IVL examining an all-comers female population with minimal exclusion criteria, the first study to encourage a Shockwave IVL-first PCI strategy for calcified coronary lesions, and the first study to follow-up with enrolled patients for three years following IVL therapy. The study enrolled 399 participants across 45 sites spanning five countries in the European Union and United States. The study is led by co-principal investigators Margaret McEntegart, M.D., Ph.D., Director of the Complex PCI and CTO programs and Cardiac Catheterization Labs at Columbia University Medical Center/NewYork-Presbyterian Hospital and Alexandra Lansky, M.D., Professor of Medicine in the section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program, Yale University School of Medicine. The study's European lead is Nieves Gonzalo, M.D., Ph.D., consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.† "Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies," said Dr. Lansky. "Our goal with the EMPOWER CAD study was to address this gap and determine whether Shockwave IVL should be considered as the front-line calcium modification approach in female patients with complex coronary artery disease. The results demonstrate the benefits of IVL use in this specific patient population and validate findings from previous studies." The primary effectiveness endpoint of procedural success, defined as stent delivery with ≤30% residual stenosis for all treated target lesions without in-hospital target lesion failure (TLF), was 86.9% at 30 days. The primary safety endpoint, defined as TLF as a composite of cardiac death, myocardial infarction attributable to target vessel (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR) within 30 days, was 12.1%. TLF was primary driven by the rate of periprocedural MI3 (10.6%); the majority of these periprocedural MIs were not associated with any clinical signs or symptoms. Cardiac death and ID-TLR rates were each 1.3%. Procedural complications were rare with only one patient (0.2%) having a serious angiographic complication when assessed at the end of the procedure. There were also clinically and statistically significant improvements in health-related quality of life scores at 30 days compared to baselines. "By leveraging a Shockwave IVL-first approach, the EMPOWER CAD 30-day results demonstrated high procedural success, low complication rates and significant improvements in quality of life among real-world female patients," said Dr. McEntegart. "While we look forward to following these patients for the next three years, these primary endpoint results confirm that excellent outcomes can be achieved with the use of Shockwave IVL in women with complex, calcified coronary artery disease." Nick West., M.D., Chief Medical Officer, Shockwave Medical, emphasized the significance of the EMPOWER CAD study, stating, "Today marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions. What began as an idea a few years ago is now a commendable reality today, thanks to study leadership and site investigators accelerating completion and reporting these important results. We're looking forward to learning more about the benefits of IVL therapy in this underrepresented patient population, both acutely and at extended follow-up." About Shockwave MedicalShockwave Medical, Inc., 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 safely 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 Cardiovascular Solutions from Johnson & Johnson MedTechAcross Johnson & Johnson, we are tackling the world's most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. About Johnson & JohnsonAt 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. Shockwave Medical, Inc. is part of Johnson & Johnson MedTech. Cautions Concerning Forward-Looking StatementsThis press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. 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 most recent Annual Report on Form 10-K, 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 a result of new information or future events or developments. † Drs. McEntegart, Lansky and Gonzalo are paid consultants of Shockwave Medical. They have not been compensated in connection with this press release. 1 Giustino et al., JACC Cardiovasc Int 2016; Ford et al., Catheter Cardiovasc Interv 2020; Hussain et al., JSCAI 2022.2 Kim et al. Catheter Cardiovasc Interv. 20163 As defined by SCAI for periprocedural MI and Fourth Universal (Type 4a) for spontaneous MI beyond discharge. Media Contacts: Lindsey Diaz-MacInnisldiazmac@ Rachael Jarnaginrjarnagi@ Investor Contact:Sandra Easton Investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson MedTech
Business Wire
06-05-2025
- Business
- Business Wire
CorFlow Therapeutics任命Chris O'Connell為董事會主席
瑞士巴爾--(BUSINESS WIRE)--(美國商業資訊)-- CorFlow Therapeutics AG (CorFlow) 高興地宣布，Chris O'Connell將接替Rick Geoffrion成為董事會主席，後者將繼續擔任董事會董事。Chris是醫療器材、生命科學和全球保健產業備受推崇的高階主管、董事會成員和顧問。Chris曾在Medtronic（MDT）工作了21年，在公司快速擴張時期任職於多個業務領域和職能部門，在成為執行副總裁暨Restorative Therapies Group總裁之前，他曾在心血管和糖尿病業務部門擔任高級領導職務，並曾任Medtronic執行委員會成員長達九年。後來，Chris出任Waters Corporation（WAT）執行長兼總裁，在他的領導下，公司的業務和股價連續五年強勁成長。目前，Chris擔任醫療器材、生命科學和診斷領域創新成長公司以及多家非營利組織的獨立董事。 CorFlow執行長Paul Mead表示：「Chris為處於關鍵發展階段的CorFlow帶來了非凡的策略和營運智慧，他的經驗將使公司受益匪淺。Chris擁有豐富的企業和董事會經驗，並曾在許多併購交易中擔任買方，因此他清楚地瞭解醫療技術領域各職能部門的卓越標準有多高。我代表董事會、股東和員工對他的加入表示熱烈歡迎。」 Paul補充說：「我想藉此機會對Rick Geoffrion在過去幾年中給予我們的個人支援和承諾表示衷心的感謝，我很高興他將以獨立身分繼續留在我們的董事會。」 Chris加入CorFlow之際，公司正著手實現雄心勃勃的B輪融資目標，其中包括兩項平行臨床試驗、一項旨在獲得美國市場銷售授權的FDA IDE試驗和一項在歐洲具有里程碑意義的隨機治療試驗。CorFlow致力於成為首家能夠為微血管阻塞的心臟病患者提供診斷及治療技術的公司，其精確的系統可介入心臟科專家的現有工作流程。該公司的首個人體MOCA I 研究結果已在最近的TCT和EuroPCR科學大會上公布，臨床前研究結果也已在歐洲心臟學會大會上發表。CorFlow在2024年底與一家國際創投財團完成了4,400萬歐元的B輪融資，近期亦追加了更多用於擴大臨床、研發和能力提升的資金。 Chris表示：「我很榮幸能加入CorFlow團隊，有機會幫助微血管阻塞患者解決尚未得到滿足的巨大醫療需求，這對我來說是莫大的激勵。CorFlow的變革性技術、才華橫溢的執行長及其團隊以及經驗豐富的投資者團體將共同推動突破性的成功。我們具備了取得卓越成就的所有要素。」 關於CorFlow Therapeutics： CorFlow總部位於瑞士巴爾，致力於成為在人體任何需要恢復健康微循環血流的部位提供診斷和治療解決方案的領導者。在瑞士創新署（Innosuisse）的資助下，CorFlow與伯恩大學、蘇黎世聯邦理工學院和蘇黎世大學醫院的研究人員密切合作，持續探索心臟及其之外領域的應用。 免責聲明：本公告之原文版本乃官方授權版本。譯文僅供方便瞭解之用，煩請參照原文，原文版本乃唯一具法律效力之版本。
