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PROVISION Study, First Ever Prospective RCT of CathWorks FFRangio Outcomes Compared to Invasive Wire-based Physiology in Japan, Meets its Primary Endpoint

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PROVISION Study, First Ever Prospective RCT of CathWorks FFRangio Outcomes Compared to Invasive Wire-based Physiology in Japan, Meets its Primary Endpoint
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PROVISION Study, First Ever Prospective RCT of CathWorks FFRangio Outcomes Compared to Invasive Wire-based Physiology in Japan, Meets its Primary Endpoint

2024-10-28 02:56 Last Updated At:03:15

PROVISION Study demonstrates significant economic and resource utilization advantages in FFRangio cohort compared to invasive wire-based FFR cohort

WASHINGTON, Oct. 28, 2024 /PRNewswire/ -- Today at the Cardiovascular Research Foundation's annual Transcatheter Cardiovascular Therapeutics (TCT) conference taking place at the Walter E. Washington Convention Center in Washington, DC, investigators from Gifu Heart Center and Fukuoka Sanno Hospital presented the results of the physician-initiated PROVISION1 Study. The investigators shared the first randomized controlled trial (RCT) of FFRangio outcomes compared to invasive wire-based fractional flow reserve (FFR) has met its primary endpoint and revealed significant economic and resource utilization advantages for the non-invasive FFRangio technology over traditional wire-based approaches.

The PROVISION Study included the enrollment of 400 patients across 13 centers in Japan. The principal investigators, Professor Hitoshi Matsuo from Gifu Heart Center and Professor Hiroyoshi Yokoi from Fukuoka Sanno Hospital, aimed to confirm that the physiological assessment with the wire-free angiography-based CathWorks FFRangio® System yields the same clinical treatment plans as those based on evaluation performed with invasive wire-based FFR, with no difference in their clinical prognoses. Additionally, the study aims to show that FFRangio offers economic advantages over wire-based FFR.

The FFRangio System combines artificial intelligence (AI) 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.

The PROVISION Study is the first Japanese prospective RCT comparing the outcomes of an angio-based physiology technology in comparison to invasive wire-based physiology. 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. For patients who underwent PCI, a post-PCI physiological assessment was performed using the respective technology, and patients will be followed clinically for at least one year.

Professor Yokoi shared, "The results from the post-PCI assessments performed on patients who underwent PCI and OMT, planned to be analyzed and reported after the completion of one-year follow-up, can provide the very much needed insight on optimal cut-off(s) for post-PCI FFR values, and provide the clinical evidence necessary to encourage routine post-PCI physiology assessment."

Professor Matsuo stated, "The results of this study are groundbreaking for coronary artery disease diagnostics in Japan. FFRangio offers a non-invasive alternative that not only matches the diagnostic accuracy of traditional wire-based FFR but also improves operational efficiencies and reduces costs for healthcare providers."

Key findings from the study include:

CathWorks President & CEO Ramin Mousavi added, "This significant milestone validates our mission of transforming how coronary artery disease is diagnosed and treatment through innovation. The results from the PROVISION Study have officially kicked off a new era in physiology, underscoring FFRangio as the new standard of care and potential to drive better patient outcomes while delivering tangible economic and resource utilization benefits to healthcare systems."

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 www.cath.works and follow @CathWorks on X and 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 Feher
mike.feher@cath.works 

Media:
Sarita Monico
sarita.monico@cath.works

Photo - https://mma.prnasia.com/media2/2541276/CathWorks_PressReleaseCard_OCT27_V1.jpg?p=medium600

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

PROVISION Study, First Ever Prospective RCT of CathWorks FFRangio Outcomes Compared to Invasive Wire-based Physiology in Japan, Meets its Primary Endpoint

PROVISION Study, First Ever Prospective RCT of CathWorks FFRangio Outcomes Compared to Invasive Wire-based Physiology in Japan, Meets its Primary Endpoint

HONG KONG, Oct. 27, 2024 /PRNewswire/ -- Phase 3 of the 2024 Global Sources Hong Kong Shows officially opened today, featuring the Global Sources Sports & Outdoor Show alongside the debut of the Global Sources Baby & Children's Products Show. The events will run until October 30 at AsiaWorld-Expo. With growing global awareness of health consciousness, the sports and outdoor industry is experiencing explosive growth. The Sports & Outdoor Show, first launched last year, has successfully captured trends in the sports industry and met global buyers' demands.

The Global Sources Sports & Outdoor Show showcases over 30,000 high-quality, fashionable, technological, and environmentally friendly sports and outdoor products, featuring approximately 600 booths from Asia. The shows cover equipment for camping, fitness, water sports, outdoor activities, sportswear, and accessories, aiming to build a comprehensive sports lifestyle ecosystem and create a one-stop fashion sports sourcing platform. The Global Sources Baby & Children's Products Show concurrently showcases baby products, toys, clothing, strollers, car seats, children's furniture, and related maternal and infant services.

John Kao, Vice President of Global Sources Hong Kong and Overseas Shows, stated: "The sports and outdoor market is experiencing unprecedented development opportunities. People's pursuit of a healthy lifestyle and love of nature are driving the robust growth of the sports and outdoor industry. Our shows follow market trends by not only providing buyers with a diverse range of high-quality sports and outdoor products but also by introducing immersive sports experiences and emerging sports programs, bringing new vitality and business opportunities to the industry. Global Sources will continue to promote the development of the sports and outdoor market and build a superior platform for global buyers and suppliers to exchange ideas and cooperate."

Newly Emerged Sports Growth: Indoor Pickleball Experience Space Added

Global Sources Sports & Outdoor breaks from traditional exhibition formats by introducing a series of immersive sports experiences for buyers. Among newly emerged sports, Pickleball has shown significant growth, with Hong Kong recently opening its first indoor Pickleball experience space, demonstrating enormous business potential and broad development prospects. Global Sources set up a Pickleball court and launches a "Pickleball Training Camp" with HKPickle.Union. Visitors can interact on-site and experience the unique charm of Pickleball under the guidance of promotional ambassadors and professional coaches, stimulating buyers' purchasing interest in the emerging sports trend.

The show has also established a Sports Carnival in Hall 5, featuring basketball, air hockey, smart bike riding, darts, table football, and other sports gaming facilities. Through a series of sports and outdoor-themed activities and competitions, buyers can enjoy sports in fun competitions while sourcing products in a relaxed and pleasant atmosphere.

Wellness & Fitness Zone: PURE Yoga Classes and Latest AR Fitness Equipment

Phase 3 of the Global Sources Hong Kong Shows has set up a special "Wellness & Fitness Zone" in collaboration with local premium fitness center PURE, bringing a series of yoga and fitness activities to buyers and exhibitors. PURE's professional yoga instructors will provide yoga experiences on-site and share yoga-related knowledge.

The experience zone will also showcase the latest AR fitness equipment, which won the 2023 Red Dot Winner Award. This equipment integrates digitalization, artificial intelligence, gym training, strength training, and smart home fitness functions, providing visitors with an immersive fitness experience. Through these activities, buyers can closely understand and experience the latest sports and outdoor products while personally participating in health and fitness practices.

International Pavilions Showcase Diversity, Innovation

The exhibition continues its internationalization, attracting pavilions from countries including India and Vietnam. The Vietnamese manufacturers' group is presenting highly competitive and cost-effective new products such as sportswear, swimwear, and functional bags. These products highlight Vietnam's increasing craftsmanship and design capabilities while bringing Southeast Asian fashion design concepts and creativity to the show. On the opening day, the Vietnam Pavilion held an opening ceremony attended by Hu Wei, CEO of Global Sources; Mrs. Le Duc Hanh, Consul General of Vietnam in Hong Kong; John Kao, Vice President of Global Sources Hong Kong and Overseas Shows; and Sam Hui, Vice President of Global Resources Strategy and International Business, who jointly witnessed this important moment.

Onsite Summit Program

Phase 3 of the Global Sources Hong Kong Shows features a series of professional forums under the theme "Thriving Together: Novel Products for Active Folks and Little Ones." The event brings together industry representatives from the E-Commerce Association of Hong Kong, Pantone, Novelty Lane, SGS, Tech Packs Co, and others to explore industry development trends and share market updates. The forums cover various hot topics, including "PANTONEVIEW Colour Planner Autumn/Winter 2025/26 - Family," "The Rise of Fashion-Forward Active Apparel and Gear," and "Navigating the Latest Pitfalls for Selling Baby and Kids Products on Amazon." A highlight forum, "Champion's Choice: Elite Athlete Unveils the Winning Gear," features Ms. Pui Yin Yip, former Olympic badminton representative, sharing insights on athletes' preferred sports apparel and equipment, meeting buyers' needs for the latest market dynamics.

Focusing on Sustainable Development and Upgrading Digital Services

As consumers' awareness of environmental protection continues to strengthen, Global Sources Hong Kong Shows, as an internationally leading B2B procurement platform, actively practices ESG principles. From the meticulous layout of the exhibition hall to the orderly organization of events, it comprehensively implements measures for environmental protection and sustainable development. In these shows, Global Sources strongly encourages exhibitors to showcase their ESG labels, making it easier for buyers to identify and select suppliers that meet environmental standards. This initiative motivates suppliers to put environmental concepts into practice and jointly promotes the green development of the industry.

At the same time, the shows have launched the feature-rich Show Genie 2.0 APP, providing visitors with more convenient exhibition features. These include fast entry through QR code registration, a search function to quickly locate desired exhibitors and products, personalized exhibition routes, and online note-taking capabilities. This greatly enhances the exhibition experience for visitors.

About Global Sources

Global Sources is an internationally recognized B2B sourcing platform that has been driving global trade for over 50 years. The Company connects authentic buyers and verified suppliers worldwide with tailored solutions and trusted market intelligence through trade shows, digital platforms, magazines and events. Global Sources' unique online-to-offline (O2O) services have successfully provided efficient and convenient commercial services to over 10 million registered international buyers and users.

This press release is distributed by Market Hubs Holdings Limited.

For Media Inquiry:

Market Hubs Holdings Limited

Lierence Li

Debbie So

+852 3998-4900

+852 3998-4900

lierence@markethubsgroup.com

debbie@markethubsgroup.com

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

Grand Opening of October 2024 Global Sources Sports & Outdoor Show Emerging Sports Rise: Pickleball and AR Fitness Take Center Stage

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