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Boston Scientific presents Watchman FLX and EKOS endovascular system data. Boston presented the pair of trial readouts at the 2026 American College of Cardiology (ACC) conference in New Orleans. Boston Scientific has shared a duo of positive data readouts from two separate trials evaluating its Watchman FLX left atrial appendage closure (LAAC) device in non-valvular atrial fibrillation (AF) patients, and its EKOS endovascular system in patients with intermediate-risk pulmonary embolism (PE). The Watchman trial evaluated whether the device represented a reasonable alternative to non-vitamin K oral anticoagulants (NOACs) in patients with non-valvular AF, while the Ekos trial evaluated whether the endovascular system was superior to the current standard of care (SoC) - anticoagulation alone - in treating patients with acute PE. The results from each study were shared during the 2026 American College of Cardiology (ACC) conference, which took place from 28 to 30 March in New Orleans, Louisiana. The findings from each study were also simultaneously published in The New England Journal of Medicine. In the 3,000-patient CHAMPION-AF (NCT04394546) trial, Watchman met its primary safety endpoint as a first-line option for stroke risk reduction in patients with non-valvular AF. The device proved statistically superior to NOACs at the three-year readout, achieving a 45% relative reduction in non-procedural bleeding risk. The study's primary efficacy endpoint, defined as the occurrence of stroke, cardiovascular or unexplained death or systemic embolism, was met, with Watchman achieving statistical non-inferiority compared to NOACs at 5.7% versus 4.8%. Including procedural bleeding in a secondary analysis, Watchman was consistent with the primary safety endpoint and demonstrated a significant reduction in bleeding compared to NOACs, representing a 34% relative reduction in procedural and non-procedural bleeding risk. "These positive data, which have the potential to support updated clinical guidelines globally, will be used in our submission to expand the indication and coverage for the well-established Watchman platform as a first-line stroke risk reduction option, providing physicians with more choices in care for a wider range of patients who have atrial fibrillation," said Brad Sutton, chief medical officer, atrial fibrillation solutions at Boston Scientific. "Today, 40% of patients with AF who are prescribed blood thinners for stroke risk reduction are not taking their medications consistently, significantly increasing their risk of stroke," Sutton added. Boston's Watchman franchise represents a key revenue driver within the company's cardiovascular portfolio. In Q4 2025, the franchise achieved a 29.4% uptick on its Q4 2024 performance, contributing $535m to Boston's $3.4bn revenue performance in Q4 2025. In the 544-patient HI-PEITHO trial (NCT04790370), Boston's Ekos system's delivery of a low dose of clot-dissolving medication directly to the blood clot to facilitate the dispersion of the medication deep into the clot to dissolve it was compared against the SoC of anticoagulation alone. Meeting the trial's co-primary endpoint of PE-related mortality, non-fatal hemodynamic cardiorespiratory decompensation or collapse and non-fatal symptomatic recurrence of PE within seven days, Ekos plus anticoagulation demonstrated superiority to anticoagulation alone at 4% versus 10.3%, representing a 61% reduction in the primary endpoint events. This result was achieved with no episodes of bleeding within the brain through 30 days. Dr Michael Jaff, vice president and chief medical officer, vascular therapies at Boston Scientific, said: "The HI-PEITHO trial evaluated clear, clinically meaningful endpoints using rigorous patient enrolment criteria and demonstrated a definitive impact with the Ekos system over the standard of care for treating acute PE. "For the first time, we have robust randomised clinical trial data available to inform treatment decisions by interventionalists and referring physicians and support consideration of Ekos plus anticoagulation as a first-line therapy." Give your business an edge with its leading industry insights.

Nominations open for the second annual Thomas J. Fogarty Prize honoring high-impact medtech innovations. $100,000 Cash Award Made Possible by the Linda and Mike Mussallem Foundation MOUNTAIN VIEW, Calif.-(BUSINESS WIRE)-Nominations open April 2 for the 2026 Thomas J. Fogarty Innovation Prize (Fogarty Prize), a prestigious recognition honoring an innovator or team that has developed and brought to market a life-changing medical technology. The award includes an unrestricted $100,000 cash prize, a custom-cast bronze medal, and a black-tie celebratory dinner and award ceremony that brings together leaders from across the medtech industry. "The Fogarty Prize and gala celebrate the innovators, mentors, and visionaries who make this industry extraordinary," said Andrew Cleeland, CEO of Fogarty Innovation. "What we do matters. We improve, restore, and sometimes save the lives of millions." Share This marks the second year of the award, which is named in honor of cardiovascular surgeon and serial medical technology innovator Thomas J. Fogarty, MD. His inventions transformed surgical practice, and his relentless pursuit of "a better way" continues to inspire generations of innovators. Fogarty passed away in December 2025. The inaugural Fogarty Prize was awarded to Allan Zingeler, Raju Viswanathan, PhD, and Michael Mahoney of Boston Scientific for the FARAPULSE(TM) PFA Platform, an advanced treatment for atrial fibrillation (AF), the most common sustained cardiac arrhythmia. The award was presented at a sold-out gala attended by more than 350 leaders from industry, venture, academia, healthcare, and local government. The Fogarty Prize was established through a founding grant from the Linda and Mike Mussallem Foundation. "The Thomas J. Fogarty Innovation Prize celebrates the boldness, creativity, and perseverance that define great innovators - qualities that Tom embodied every day," said Mike Mussallem, co-founder of the Linda and Mike Mussallem Foundation and former CEO and Chairman of the Board of Edwards Lifesciences. "Tom believed that, with the right innovation, medicine could always do better for patients, and he lived that conviction with integrity, generosity, and unwavering drive. This prize honors his remarkable legacy and his lifelong mission to empower others to challenge convention and solve healthcare's toughest problems." The Prize highlights the journey from idea to impact, recognizing the collaboration, persistence, and multidisciplinary effort required to drive a new therapy to patients and achieve broad acceptance and use. It also brings the medtech community together to celebrate breakthrough ideas and the shared mission of improving patient care. "The Prize and gala celebrate the innovators, mentors, and visionaries who make this industry extraordinary," said Andrew Cleeland, CEO of Fogarty Innovation, the nonprofit educational medtech incubator founded by Fogarty that administers the Prize. "What we do matters. We improve, restore, and sometimes save the lives of millions around the world." Eligibility and Dates The Fogarty Prize recognizes a singular, clinically impactful technology. Nominees should embody the core values that define Dr. Fogarty's legacy - relentless curiosity, bold vision, technical excellence, and a deep commitment to improving human health. Recipients must be individuals (up to three per award). Nominations open April 2, 2026, and close July 31, 2026. The nomination form is available on the Fogarty Innovation website. Dr. Fogarty's Impact on Medical Innovation During his acclaimed career, Fogarty acquired 190 medical patents, including the Fogarty Balloon Embolectomy Catheter, the Hancock Tissue Heart Valve, and the AneuRx Endovascular Aortic Stent Graft. He founded or co-founded more than 45 medical technology companies and was honored by numerous organizations for his contributions to medical science, including induction into the National Inventors Hall of Fame and receipt of the Presidential Medal of Technology and Innovation. Recognizing that developing new medical technologies and bringing them to patients was "damn hard," Fogarty founded Fogarty Innovation in 2007 on the campus of El Camino Health to mentor the next generation of innovators and create an environment of camaraderie, education, and support. The organization has been led by Cleeland since 2017. About Fogarty Innovation Fogarty Innovation is a nonprofit educational medtech incubator dedicated to advancing human health worldwide. The organization's seasoned team helps companies navigate the path to commercialization, delivers practical educational programming to stakeholders across the ecosystem, and forges alliances that accelerate the invention, development, and deployment of new medical technologies into clinical care. Founded by Thomas J. Fogarty, MD, a world-renowned cardiovascular surgeon, inventor, and entrepreneur, Fogarty Innovation is headquartered on the campus of El Camino Health in Mountain View, California. Learn more: www.fogartyinnovation.org. About the Linda and Mike Mussallem Foundation After decades of philanthropic commitments, Linda and Mike officially unveiled the Linda and Mike Mussallem Foundation in 2024. The Foundation aims to harness the power of innovation and integrative health solutions to address complex healthcare challenges and create meaningful, long-lasting change for overlooked populations in need. Learn more: www.mussallemfoundation.org. More News From Fogarty Innovation MOUNTAIN VIEW, Calif.-( BUSINESS WIRE )-FARAPULSE team wins inaugural Thomas J. Fogarty Innovation Prize for transformative AFib therapy at SF gala celebration with medtech community... MOUNTAIN VIEW, Calif.-( BUSINESS WIRE )-Finalists for the inaugural Fogarty Prize are therapies that have transformed the treatment of cancer, atrial fibrillation and serious birth defects... MOUNTAIN VIEW, Calif.-( BUSINESS WIRE )-Thomas J. Fogarty Prize launches to recognize high-impact medtech innovations... Fogarty Innovation. Release Summary Nominations open April 2 for the 2026 Fogarty Prize, a $100,000 award honoring an innovator or team behind a life-changing medical technology Release Versions

Boston Scientific has raised $120 million in a Series C round led by Ribbit Capital, valuing the company at $1.45 billion. Sequoia and Kleiner Perkins participated, whilst Emerson Collective joined as a new backer. The pre-revenue startup is developing "Mathematical Superintelligence", focusing on advanced reasoning that eliminates AI hallucinations by requiring outputs in Lean4 programming language for verification. Its Aristotle model achieved top performance at the International Mathematical Olympiad in July. Founded in 2023, the company has raised $295 million across three rounds in 14 months. It currently offers Aristotle via free API and targets commercialisation in safety-critical sectors like aerospace and finance.