Edwards Lifesciences Corporation is a global leader in patient-focused medical innovations for structural heart disease and critical care monitoring. The company develops and manufactures heart valve systems and repair products, including surgical and transcatheter therapies, as well as hemodynamic and noninvasive brain and tissue oxygenation monitoring systems. Edwards partners with clinicians and researchers, investing in R&D to transform care for those impacted by structural heart disease or who require hemodynamic monitoring during surgery or in intensive care. The company's vision is to transform patient care where patients are diagnosed earlier, treated in a routine fashion, living longer and enjoying a better quality of life.

Edwards' innovative work in heart valves encompasses both surgical and transcatheter therapies for heart valve replacement and repair. The company is also a global leader in hemodynamic and noninvasive brain and tissue oxygenation monitoring systems used to measure a patient's cardiovascular function in the hospital setting. The company's products are categorized into four main groups: Transcatheter Aortic Valve Replacement, Transcatheter Mitral and Tricuspid Therapies, Surgical Structural Heart, and Critical Care.

• Employees: Approximately 19,800 (as of December 31, 2023)
• Geographic Footprint: Approximately 100 countries
• Headquarters: Irvine, California
• Founded: Over six decades ago
• Number of locations/facilities: Manufacturing facilities in the United States (California and Utah), Singapore, Costa Rica, and Ireland. Critical Care products are primarily manufactured in the Dominican Republic and Puerto Rico.
• Revenue: $6.0 billion (FY2023)
• Market Share: Global leader in transcatheter heart valve replacement technologies
• Key Subsidiaries/Brands: Edwards SAPIEN family of valves, RESILIA tissue, INSPIRIS RESILIA aortic valve, MITRIS RESILIA valve

• CEO: Bernard J. Zovighian
• CFO: Scott B. Ullem
• Board Chair: Michael A. Mussallem

• Annual Revenue: $6.0 billion (FY2023)
• Net Income: $1.4 billion (FY2023)
• Total Assets: $9.4 billion (as of December 31, 2023)
• Key Financial Highlights: Research and development spending increased 13% year over year, representing 18% of 2023 sales.

Edwards offers a range of products and technologies categorized into four main groups:

• Transcatheter Aortic Valve Replacement (TAVR): Minimally-invasive replacement of aortic heart valves, including the Edwards SAPIEN family of valves.
• Transcatheter Mitral and Tricuspid Therapies (TMTT): Transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases, including the PASCAL PRECISION and Cardioband systems.
• Surgical Structural Heart: Surgical tissue heart valve products, including the INSPIRIS RESILIA aortic valve and MITRIS RESILIA valve.
• Critical Care: Advanced hemodynamic monitoring systems used to measure a patient's heart function and fluid status, including the FloTrac and Acumen IQ sensors, the ClearSight and Acumen IQ cuffs, and the ForeSight tissue oximetry sensor.

Edwards' products and technologies are categorized into four main groups:

• Transcatheter Aortic Valve Replacement (TAVR): Represented 65% of net sales in 2023.
• Surgical Structural Heart: Represented 16% of net sales in 2023.

Edwards is focused on delivering clinically advanced new products, enhancing the effectiveness, ease of use, safety, and reliability of current products, and expanding the applications of its products. The company is engaged in ongoing research and development to deliver clinically advanced new products, to enhance the effectiveness, ease of use, safety, and reliability of current leading products, and to expand the applications of our products as appropriate. The company focuses on opportunities within specific areas of structural heart disease and critical care monitoring. Key strategic initiatives include significant investments in transcatheter structural heart programs, including mitral, aortic, and tricuspid therapies. Edwards is also pursuing the development of a variety of decision support solutions for clinicians in the Critical Care product line.

On December 7, 2023, Edwards announced its intention to complete a tax-free spin-off of its Critical Care product group around the end of 2024. The planned separation will enable the company to pursue expanded opportunities for TAVR, TMTT, and Surgical patients, as well as new investments in interventional heart failure technologies.

The medical technology industry is highly competitive. Edwards competes with divisions of larger companies and smaller companies that offer competitive product lines in certain geographies. They also compete with both established and newer technologies that target the patients served by their products. The company believes it holds leadership positions due to its development and production of safe and effective therapies supported by rigorous clinical studies and innovative features that can enhance patient benefit and product performance and reliability.

• Market Position: Global leader in transcatheter heart valve replacement technologies.
• Key Competitors: Medtronic PLC, Abbott Laboratories, Boston Scientific Corporation, Artivion, Inc (formerly CryoLife), ICU Medical, Inc., PULSION Medical Systems SE, Cheetah Medical, Inc., and LiDCO Group PLC.
• Industry Trends: The cardiovascular segment of the medical technology industry is dynamic and subject to significant change due to cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient needs. The ability to provide products and technologies that demonstrate value and improve clinical outcomes is becoming increasingly important for medical technology manufacturers.

• Business and Operating Risks: Failure to successfully innovate and market products, unsuccessful clinical trials or procedures, manufacturing, logistics, or quality problems, public health crises, competition, dependence on key physicians and research institutions, reliance on vendors and suppliers, damage to IT systems, failure to recruit and retain qualified talent, underperforming operations or unsuccessful business acquisitions, and risks related to the spin-off of the Critical Care product group.
• Market and Other External Risks: Risks associated with international sales and operations, inability to obtain government reimbursement or reductions in reimbursement levels, and industry consolidation.
• Legal, Compliance and Regulatory Risks: Inability to protect intellectual property, inability to defend against intellectual property claims, compliance with government regulations, losses from product liability claims, use of products in unapproved circumstances, substantial costs from environmental, health and safety regulations, climate change, and regulatory actions relating to animal-borne illnesses.