Sustainability report

Organizational profile

Our business

Edwards is incorporated in Delaware, U.S., and headquartered in Irvine, California, U.S. We operate major manufacturing facilities at multiple locations in the U.S., as well as in the Dominican Republic, Costa Rica, Singapore, Puerto Rico and Ireland. We also have a significant employee presence at regional sites across the world. None of our North American employees are represented by a labor union. In various countries outside of North America, we interact with trade unions and work councils that represent a limited number of employees.

Edwards by the numbers

As of December 31, 2022

Total Number of Properties
(leased and owned properties; does not include sales or field offices)
(7 manufacturing locations)
Total Number of Employees 17,300
Global Employees by Gender 59% Female
41% Male

MAP - Edwards by the numbers


Edwards Lifesciences was established as an independent, publicly traded company on April 3, 2000, and since then the company has grown to more than $5 billion in sales in 2022 across approximately 100 countries. We are dedicated to the development of lifesaving and life-enhancing medical technologies that improve patient outcomes. Our technologies include transcatheter and surgical heart valve therapies and critical care technologies, such as:

  • Transcatheter Aortic Valve Replacement – Edwards continues to lead the development of transcatheter heart valve technologies, enabling a streamlined procedure with excellent outcomes, timely discharge and improved quality of life for patients with severe symptomatic aortic stenosis, a type of heart valve failure. Through significant investment in technology advancement and clinical evidence, Edwards strives to further expand the treatment options for patients with heart valve failure.
  • Transcatheter Mitral and Tricuspid Therapies – Edwards is making significant investments in the development of a differentiated portfolio of therapy options designed to treat mitral and tricuspid valve diseases.
  • Surgical Structural Heart – Edwards is committed to working closely with cardiac surgeons and helping transform patients’ lives by advancing surgical structural heart innovations. Edwards is the world’s leading manufacturer of tissue heart valves and surgical heart valve repair therapies, which are used to treat a patient’s diseased heart valve.
  • Critical Care – Edwards is a world leader in advanced hemodynamic monitoring systems used to measure a patient’s heart function and fluid status in surgical and intensive care settings. The company’s hemodynamic portfolio helps clinicians make proactive clinical decisions and plays an important role in enhancing surgical recovery.

Every year, Edwards Lifesciences continues to innovate life-saving therapies. In 2022, Edwards Lifesciences introduced several products for commercial use and secured approvals in various countries for specific uses of Edwards’ products. Examples include:

  • U.S. Food & Drug Administration (FDA) approval for the MITRIS RESILIA valve, a dry tissue valve replacement specifically designed for the heart's mitral position.
  • FDA approval for the PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) for the treatment of patients with degenerative mitral regurgitation (DMR).
  • Receipt of CE Mark for the PASCAL Precision transcatheter valve repair system for the treatment of mitral regurgitation (MR) and tricuspid regurgitation (TR).
  • Approval and launch in Japan, the U.S. and the E.U., of the SAPIEN 3 Ultra RESILIA valve, which incorporates Edwards' breakthrough RESILIA tissue treatment technology with the industry-leading SAPIEN 3 Ultra transcatheter aortic heart valve.

Please see our Newsroom for updates on our latest innovations and approvals, as well as our Investor Relations site for quarterly Fact Sheets.

2022 Sales by product line

  • Transcatheter Heart Valve Therapy
  • Surgical Structural Heart
  • Critical Care
  • Transcatheter Mitral and Tricuspid


2022 Sales by geographic region

  • United States
  • Europe
  • Japan
  • Rest of World


Value chain

A value chain represents the full process of creating a product from material sourcing to production, from use to disposal. We consider our full value chain, including our relationships with suppliers and customers, to drive the innovation of new solutions, ensure the quality of our products, and increase our reach to help as many patients as possible.


Our customers include physicians, medical professionals, hospitals, and group purchasing organizations. In 2022, we derived 58% of our sales from customers in the U.S.

Direct suppliers

Our primary direct materials suppliers provide:

  • Bovine pericardial tissue
  • Chemicals
  • Contract manufacturing
  • Electronic assemblies and cables
  • Extruded tubing and extrusions
  • Guidewires
  • Injection molded components
  • Packaging materials
  • Precision machining components

We typically only add partners to our direct supplier portfolio if a new technology or capability is required for our business and is not already present in our supplier base. New suppliers undergo a thorough due diligence process, including screening for adverse conditions or events. We prioritize partnerships with suppliers headquartered in countries that enforce stringent standards and regulations to help reduce risks of non-compliance in our supply chain. Our largest indirect suppliers provide telecommunication services, food and catering services, office supplies, uniforms, lab products and cloud software.

2022 external awards and recognitions

  • Most Sustainable Companies (Barron’s)
  • Management Top 250 (Wall Street Journal)
  • America’s Most Responsible Companies (Newsweek)
  • America’s Most Just Companies “JUST 100” (JUST Capital/Forbes magazine)
  • Top 100 Companies Supporting Healthy Families and Communities (JUST Capital)
  • World’s Most Ethical Company (Ethisphere)
  • World’s Top Female-Friendly Companies (Forbes)
  • America’s Best-in-State Employers: California (Forbes)
  • Humankind 100 (Humankind Investments LLC)
  • Trendsetter in Corporate Political Disclosure and Accountability (CPA Zicklin Index)

Governance map

This Governance Map outlines the accountability structure and strategy development process for several of our key topics. By selecting a topic and clicking through the questions, you can access information about our strategy for the key areas.

Health & Safety
Ethics &
Product Safety
& Quality
& Giving
Human Capital
Supply Chain
Edwards takes pride in our strong management practices that mitigate risk, ensure accountability and enhance performance on our material topics. Our governance maps illustrate Edwards’ internal responsibility structures for managing a selection of our material topics. These maps underscore our commitment to transparency and our Aspiration of Excelling as a Trusted Partner and Global Leader Through the Quality of Our Work.
Please click on any of the seven categories to review our governance structures and practices.
Corporate Governance
How does Edwards establish its policies and practices?

  • The Edwards Board of Directors and the Executive Leadership Team are responsible for corporate governance at Edwards. See pages 13-19 of our 2023 Proxy Statement.
How is the oversight structured at Edwards?
How does Edwards engage and communicate policies and practices?
  • Communication practices

    We communicate Edwards’ corporate governance efforts with internal and external stakeholders through our annual Proxy Statement and other securities filings with the Securities and Exchange Commission.

    Shareholder engagement

    The Board is presented with the status of shareholder engagement and feedback during the quarter in which the feedback was obtained. We conduct shareholder outreach on the topics of corporate governance, executive compensation, and sustainability at least twice a year. The Board reviews feedback from external stakeholders, discusses reasonable actions, and responds on behalf of the company.

    Shareholders can communicate governance concerns by contacting our Investor Relations team or the office of the Corporate Secretary. They can also raise concerns during one of our semi-annual outreach campaigns. See pages 13-19 of our 2023 Proxy Statement.
Health & Safety
How does Edwards establish its policies and practices?

  • Members of the Worldwide Environmental Health and Safety (WWEHS) team annually refresh and realign Edwards’ EHS strategy by conducting a benchmarking exercise, assessing Edwards’ performance against internal targets, identifying the needs and expectations of our stakeholders and reviewing industry best practices. The WWEHS team takes those perspectives and collaborates with internal stakeholders to create a draft strategy for the upcoming year.

    The draft strategy is then presented to the Corporate Vice President (CVP) of Global Supply Chain and Quality (GSC&Q), the Executive Leadership Team (ELT), and the Chief Executive Officer (CEO). Each of these stakeholders provides feedback, insight and direction, which the WWEHS team incorporates into the strategy. In some cases, components of the proposed EHS strategy are shared with the Board of Directors for review, input and approval.
How is the oversight structured at Edwards?

  • Once the corporate-level EHS strategy is approved, it is rolled out across Edwards globally. Site and regional leaders take the strategy and build it into their operating plans and budgets for the following years.

    The WWEHS team reports under our CVP of GSC&Q . The WWEHS team is responsible for providing guidelines, templates and resources to drive the standardization of EHS management and continual improvement in our performance across the GSC function.

    At the site and region level, Site and Region EHS Facilities teams execute projects. Each Operating Unit EHS function develops additional policies and procedures tailored to its activities and local regulations, needs and culture. The Site and Region EHS Facilities teams and the site and region leadership are responsible for ensuring adherence to the EHS policy at each facility.

    Performance incentives

    At Edwards, we annually measure companywide EHS performance against internal targets and objectives and incorporate these measurements into financial incentive programs for company leadership, including the VP of EHS, plant general managers and the CVP of GSC&Q.

    Also, we include EHS criteria in performance reviews for relevant employees, based on role, and offer incentives such as recognition, rewards and bonus compensation.
How does Edwards engage and communicate policies and practices?

  • We use a multi-faceted approach to communicate our EHS strategy and programs with our global employees. An important component of our communication efforts is the EHS training we provide to employees to raise awareness about safe and environmentally responsible work practices. We use a variety of formats to deliver material, including instructor-led, web-based, read-and-review and on-the-job training. Training requirements vary by location and by role, based upon local EHS legal requirements and employee job assignments.

    For EHS topics that are not covered in formal training courses but might require general employee awareness, we socialize content through safety communication boards, televisions onsite, electronic newsletters, EHS Incident Alerts and team huddle safety talks. We also include Edwards’ Environmental Health and Safety policy and performance commitments in the Titanium Book.

    We routinely engage with external stakeholders on the topic of Edwards’ EHS strategy. Most often, this communication takes place through investor inquiries, customer bids and tenders and the stakeholder engagement stage of our materiality assessments.
Ethics &
How does Edwards establish its policies and practices?

  • Edwards’ Executive Leadership Team (ELT), with assistance by Edwards’ Chief Compliance Officer (CCO), is accountable for Edwards’ Global Compliance Program. The CCO reports directly to the Audit Committee of the Board with administrative support and oversight by the General Counsel. The CCO provides regular updates on the Global Compliance Program to the Audit Committee and ELT.

    The CCO also chairs a Corporate Compliance Committee, comprising executives across multiple functions and business units. The committee meets quarterly to discuss emerging compliance risks, compliance program effectiveness, and progress on significant compliance program initiatives. Regional Compliance Officers also chair Regional Compliance Committees that roll up to the Corporate Compliance Committee.

    Five teams report into the CCO: Global Compliance/Compliance Operations, U.S. Compliance/Transparency, Europe/EEMEA/LATAM/Canada Compliance, Japan/Asia Pacific Compliance, and Investigations/Monitoring. The U.S. Compliance/Transparency region, the Europe/LATAM Compliance region, and the Japan/Asia Pacific Compliance region are each overseen by a Regional Compliance Officer (RCO).
How is the oversight structured at Edwards?
  • Edwards’ Credo and its Global Business Practices Standards, also known as the Titanium Book, serve as the foundation for Edwards’ Global Compliance Program. We consider the Titanium Book to be our Credo in action. The Titanium Book sets forth our values and expectations for all employees. The Titanium Book applies globally to all of Edwards’ businesses and subsidiaries and to all officers, members of the Board of Directors, employees, and third parties doing business with or on behalf of Edwards. We translate the Titanium Book into eight languages, and all professional employees are required to annually certify that they have read and agree to follow the Standards.

    All employees at Edwards are expected to raise questions and report concerns about potential violations of the law or our policies and standards. We provide employees with several communication channels for raising questions or concerns, which we outline in the Titanium Book, on the employee intranet, on posters throughout our facilities, via wallet cards, and more. Through our Speak Up program, we maintain a third-party hosted and secure reporting channel, the Edwards Integrity Helpline, that is available to both employees and external parties and allows for anonymous reporting. The Helpline can be accessed by telephone or a web portal, is available 24 hours a day, 7 days a week, and all reports are fully investigated and tracked.
How does Edwards engage and communicate policies and practices?

  • All Edwards employees must complete training relevant to their roles, including training on applicable legal compliance requirements, our Global Business Practices Standards, and company policies and procedures. We provide appropriate education and training to our employees to help them meet their ethical and compliance obligations. We regularly review and update our training program to ensure our employees remain informed and knowledgeable about evolving compliance requirements. We supplement training with a compliance-specific communications strategy to remind employees of their responsibilities and the resources available to them when they need guidance.
Product Safety
& Quality
How does Edwards establish its policies and practices?

  • As a medical technology company, Edwards must comply with strict regulations regarding the design, development, manufacturing, and distribution of our products and services. We must comply with standards set by regulatory bodies all around the world, including the U.S. Food and Drug Administration (FDA), National Competent Authorities in the European Union, and various international organizations.

    With guidance from the Board of Directors, the CEO, and the Senior Vice President of Quality and Regulatory Compliance (Chief Quality Officer) set Edwards’ Product Quality and Safety strategy, policies and targets. The Chief Quality Officer is responsible for evaluating company performance; aligning our strategy to relevant product safety regulations; assessing product quality and safety data through a company-wide dashboard; and providing quarterly updates to the Executive Leadership and Board of Directors.

    The Heads of Quality for the Business Units and Regions and SVP, Corporate Quality and Regulatory, report directly to the Chief Quality Officer and support the strategy development process. The Heads of Quality for the Business Units are responsible for product-level specifications to ensure compliance with applicable regulations.
How is the oversight structured at Edwards?

  • Edwards’ Executive Leadership Team (ELT), with assistance by Edwards’ Chief Quality Officer (CQO), is accountable for the development, implementation and maintenance of our Quality System.
    The Chief Quality Officer conducts quarterly reviews with the CEO, the Executive Leadership Team (ELT), and the Board of Directors to inform them of any significant quality issues. The reviews also provide a dedicated time for company leadership to discuss opportunities to improve Edwards’ Quality System, policy, and key objectives. These ongoing assessments empower Edwards’ Heads of Quality for the Business Units to implement changes and mandate relevant corrective actions. They assist in the communication and dissemination of the strategy to employees throughout the company.

    Performance Incentives

    Our Quality Leadership collaborate to establish a product quality performance dashboard. All members of the Quality and Global Supply Chain teams are evaluated based on the performance of those components and reflected in the dashboard.

    Corrective Action Process

    If a product fails to meet safety or regulatory requirements, a cross-functional team performs an in-depth assessment to determine whether a field corrective action is needed. In the case of a product issue, the Field Corrective Action Team will reclaim the distributed product or contact the affected customer. This team includes the Chief Quality Officer; SVP of Product Safety; Head of Quality Compliance; and the Quality Management Representative of the relevant business unit.
How does Edwards engage and communicate policies and practices?

  • Employee product quality and safety training

    Edwards requires every employee, regardless of department, to complete detailed quality training programs during our onboarding process. We assign additional training content and performance expectations specific to each role.

    Feedback mechanisms

    The Product Quality teams collaborate with our Research and Development department and Manufacturing team to monitor post-market product performance and manage a feedback loop to continually make product improvements. Additionally, we solicit feedback from physicians to better understand how we can develop our products to best meet their needs.

    Communication methods

    Edwards communicates our progress on product quality efforts and engages our stakeholders in the process through our annual sustainability report and our corporate website. Additionally, we report on product and service quality issues to all major regulatory bodies around the world, including the National Competent Authorities. Complete information on any Edwards’ product recalls is available through the FDA publicly available database.
Volunteerism & Giving
How does Edwards establish its policies and practices?

  • The Edwards Lifesciences Foundation is an independent, legally separate entity from Edwards Lifesciences and is a key element in funding our philanthropic strategy. The Global Corporate Giving team works with the Foundation’s Board of Directors – composed of several Edwards’ senior leaders – to set the vision, strategy and goals of the Foundation.

    The Foundation’s Board of Directors annually reviews the strategic plan to assess the effectiveness of the Foundation’s activities and guide any changes in strategy. The Executive Director of the Foundation leads the Global Corporate Giving team in the process of translating the strategy into an operating plan that serves as the roadmap for the year. The Foundation’s leadership also incorporates input from members of the Administrative Steering Committee (ASC), a group composed of approximately 20 Edwards employees from around the world nominated to address specific talent and regional leadership needs of the Foundation.

    The Foundation and Global Corporate Giving teams conduct a robust impact reporting practice for Every Heartbeat Matters to assess the effectiveness of donations and progress toward our commitment to underserved patients.
How is the oversight structured at Edwards?

  • The Executive Director of the Foundation is responsible for the execution of the philanthropic strategy and oversees all aspects of Global Corporate Giving. The Executive Director of the Foundation received support from the Global Corporate Giving team, which is accountable for target achievement, and the ASC, which partners with and supports charitable organizations across the world.

    The ASC and the Strengthen Our Community Committees work with the Global Corporate Giving team to encourage employees to engage with charitable organizations supported by the Foundation. These committees seek to support and inspire all Edwards employees to engage in our culture of giving through charitable activity, such as donating time to support charitable organizations, making financial donations and encouraging charitable organizations to apply to the annual giving cycle of the Foundation
How does Edwards engage and communicate policies and practices?
  • Communication Practices

    We are committed to transparently communicating our giving activities and we disclose data on our website, through our annual Sustainability Report, and through our annual Global Corporate Giving Report. During new employee orientation, we also provide information on the Foundation, the Strengthen Our Community charitable activity programs and how to get involved.

    The Global Corporate Giving team, the ASC and the Board of Directors communicate Edwards’ philanthropic strategy and commitment internally and externally through regular All Employee Meetings, external conferences, community events, our EHM Partner Summit and during Edwards’ annual shareholder meeting.

    Feedback and engagement mechanisms

    The Global Corporate Giving team uses internal communication platforms, external social media platforms and public websites to both gather feedback and share information with our employees and communities about our giving efforts. The Global Corporate Giving team responds to all email, phone or online inquiries received by the Foundation. The Executive Director and Global Corporate Giving team compile and share feedback and other material updates with the Foundation Board of Directors during quarterly meetings.
Human Capital Management
How does Edwards establish its policies and practices?

  • At Edwards, we consider human capital management to encompass the topics of employee attraction, recruitment, engagement, development, retention and diversity and inclusion.

    Edwards’ leadership understands that our greatest assets are our employees, their unique knowledge and skills, and the way they collaborate within the workplace. Attracting, developing and retaining talent is fundamental to the success of Edwards. We employ, develop and retain employees based on merit, qualifications, potential and competence, without regard to an employee’s gender, race or any other protected characteristic. The Board of Directors, CEO and Executive Leadership Team (ELT) help determine the company’s fair and equitable pay policy.

    To develop and consistently implement our company-wide talent strategy, our CEO has Performance Management Objectives related to talent, increasing diversity and building an inclusive culture. The Board annually sets the CEO’s PMOs, and the CEO is accountable to the Board for those goals. Based on the CEO’s PMOs, the ELT establishes annual key operating drivers (KODs) to steer the company toward short, medium and long-term goals. The ELT then works to identify strategic talent-related imperatives that are critical to achieving the KODs. Each strategic talent imperative is owned by an ELT member and an HR leader.
How is the oversight structured at Edwards?

  • We work to ensure equitable and fair pay practices and to provide a work environment that recognizes each individual as an important member of the Edwards team. We aspire to be an employer of choice and do so through our culture, educational opportunities, competitive pay, benefits and other efforts.

    Based on the current KODs, the ELT and respective HR owners develop and execute initiatives for each strategic talent imperative. Initiative owners determine project direction, including resources involved, goal setting and milestones for success. The HR Strategy & HR PMO team manages all strategic talent initiatives and goals to ensure alignment with business objectives and track annual progress. The Corporate Vice President of Human Resources reviews strategic talent imperatives every quarter. The HR Strategy & HR PMO team tracks the strategic talent imperatives as well as talent-related projects and global initiatives that incorporate two or more cross-functional teams.

    The HR PMO office reviews all projects using the same criteria. A resource dashboard collects and relays information and updates on each of the key projects so that the HR Advisory Board and project teams can stay in close communication. The HR Leadership Team (HRLT), joined by several other internal leaders, make up the Advisory Board, which measures completed projects against the initial timeline and expectations. The Advisory Board reviews the status of all critical talent-related projects every two to three weeks, depending on the activity.

    Our team leverages a formal Talent Development Review (TDR) process to assess the strategic talent needs of the organization, measure current talent capabilities and provide support to employees in reaching their professional goals. People managers conduct TDRs for their direct reports to connect with employees, identify professional growth priorities and understand the best way to support the needs of their function and the team members. Our CEO and Chief Human Resources Officer conduct an annual TDR with each ELT member to understand the workforce needs specific to each business function.

    To attract top talent, we offer competitive compensation and benefits packages. With the support and involvement of our Board, the ELT and external consultants, we regularly review our pay practices and compensation structure to identify any pay disparities across gender and race. Through this process, we can identify statistically significant pay disparities and create appropriate action plans.

    Our Global Career Framework (GCF) provides role alignment, career pathways and a structure to ensure equitable pay based on job responsibility. Through the GCF, we organize all Edwards employees into career bands based on job function and responsibilities. We follow the GCF to ensure internal pay equity and to align with external benchmarks to remain competitive with our compensation. Our team conducts an annual benchmark of our global job grades and salary structures.

    We assign every business group a Human Resources Business Leader (HRBL). Employees can reach out to their corresponding Human Resources Business Partner with concerns or when looking for support.
How does Edwards engage and communicate policies and practices?
  • To provide context around talent goals and explain global strategy to HR employees, our Corporate Vice President of Human Resources holds a quarterly virtual meeting. For HR employees at the senior manager level and above, we hold an annual HR Summit at our corporate headquarters. At the HR Summit, the Global HR leadership team presents updates to our strategy as well as key projects. Our Corporate Vice President of HR also hosts hours where she is available for questions and discussions through our internal chat function. We also send out a company-wide Human Resources newsletter that covers different programs and updates at the company.

    We invite all Edwards employees to share their feedback through regular anonymous surveys known as myVoice. These surveys measure employee engagement and sentiment across a variety of dimensions, including quality, empowerment and charitable activities. Edwards distributes the survey in multiple languages to facilitate participation across our global workforce. The feedback we collect through the survey helps us sustain what we do well and respond to opportunities for improvement. Leaders at all levels review survey results and collaborate with their teams to address opportunities.

    Our Employee Resource Groups (ERGs) offer a space for support, engagement, networking, and outreach for our employees. Each group hosts learning opportunities and events for the broader employee body to strengthen the Edwards community and help communicate our Diversity, Inclusion and Belonging strategy. Edwards also maintains internal webpages to communicate our human capital management strategy. Edwards’ intranet site contains employee resources and, specifically, a Diversity and Inclusion site that includes tools and resources for our employees. The site provides a launch kit for new ERG leaders.
Supply Chain Management
How does Edwards establish its policies and practices?

  • Edwards’ Global Supply Chain (GSC) organization is responsible for the plan, source, make and deliver functions of our business, ensuring that our products effectively reach providers and patients. The GSC Leadership Team and Corporate VP of GSC developed the group’s strategy by first identifying the future aspirations that guide our initiatives.
    Our GSC strategy has five pillars, and we revisit and update its components annually. The five pillars of the strategy are
    1. Enable growth, 2. Invest in quality and reliability, 3. Drive efficiency and asset effectiveness, 4. Transform the supply chain through innovation and 5. Build talent and organization.

    The GSC and Quality Leadership Teams conduct an annual strategic plan review. The group’s strategic plan looks across a seven-year horizon and aims to consider the resources required to meet the company’s long-term needs. GSC also collaborates closely with the four product lines to ensure alignment across goals, strategies and plans for growth. During the Annual Operating Plan (AOP) process, the GSC team updates its focus for the year and associated resourcing approach to align with the latest iteration of the corporate-level business plan. The GSC team has a designated Strategy Process Champion, who sets policy deployment targets, works with project teams to drive progress and presents updates to the GSC team for review.

How is the oversight structured at Edwards?

  • To execute our GSC and Quality strategies, the teams collaborate to align on goals and solicit the input of the Global Supply Chain Leadership Team (GSCLT). During the alignment process, the GSCLT helps identify and secure the resources needed to reach the goals for that year. The members of the GSCLT align their Performance Management Objectives with those of the CEO, to ensure their efforts support the broader direction of the business.

    The GSCLT assigns a project lead to own each GSC initiative and drive progress toward it. Each initiative has a sponsor from the GSCLT who oversees the project lead and helps arrange the appropriate team necessary to reach the objective.

    To execute the strategy at the local level, supervisors or managers at all Edwards plants hold daily production meetings to review performance metrics from the previous day and week. This practice ensures leaders in all plants understand the overarching strategy and that they are active in executing daily changes necessary to reach overarching goals.

    Performance monitoring

    To align the implementation of our GSC strategy across Edwards, there is one GSCLT member in each business unit. Additionally, PMO Leads sit on the GSCLT and have primary responsibility for strategy development and execution for the GSC team.

    The Edwards GSC team works closely with our Quality team to set and monitor progress toward goals. Members of these groups also collaborate with Edwards’ Research and Development teams to consider manufacturability in the design of new products.

    Monitoring suppliers

    Part of our supply chain strategy includes processes for monitoring and engaging our suppliers. We use Quarterly Business Reviews to connect with our key and strategic suppliers on a range of topics, including sustainability. Within our Strategic Sourcing Team, there is an Advanced Sourcing Team and a Category Leadership Team. All Research and Development teams have Advanced Sourcing Team representatives to identify appropriate suppliers during the product innovation process. The Category Leadership Team includes experts and category leads who own relationships with our suppliers.
How does Edwards engage and communicate policies and practices?
  • Internal communication practices

    To align all Edwards supply chain employees on our corporate goals, we post visuals of our Aspirations and GSC team strategies at all manufacturing sites. The GSC team maintains a scorecard for each plant to track progress toward site-specific goals. Plant leadership updates the scorecards regularly and conducts town hall reviews to share performance strengths and opportunities with all employees.

    Annually, the GSC directors gather for a two-day summit to discuss progress from the year prior and to create the strategy for the upcoming year. Each function of the supply chain holds a series of town hall meetings throughout the year, during which leaders roll out new projects or provide updates on existing projects. Managers conduct ongoing reviews of individual employee PMOs to monitor progress and alignment with overarching goals.

    External communication practices

    We rely on our suppliers to help us create industry-leading therapies for addressing cardiovascular disease and critical illness. Our Responsible Supply Chain Policy outlines our expectations for suppliers, which include fair labor practices, environmental responsibility, workplace health and safety, ethical practices, protection of human rights, socially responsible behavior and legal compliance.

    To engage suppliers in the Edwards’ strategic plan, we hold supplier summits with our key suppliers, distribute key elements of the GSC vision and strategies, operate a supplier portal and provide a scorecard to update suppliers on their performance against our expectations. A Change Management Group within GSC develops and publishes a quarterly newsletter that goes out across the global supply chain in both English and Spanish. The Change Management Group reports up through the leadership for GSC Human Resources.

In this section

Important Risk Information

Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System

The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.

The Edwards SAPIEN 3, SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring who are judged by a Heart Team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).

Contraindications (Who should not use):

The Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System should not be used in patients who:

Warnings: Precautions:

The long-term durability of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 transcatheter heart valves are not known at this time. Regular medical follow-up is recommended to evaluate how well a patient’s heart valve is performing. Limited clinical data are available for transcatheter aortic valve replacement in patients who are born with an aortic heart valve that has only two leaflets and who are determined to be at low risk for open heart surgery. A patient’s anatomical characteristics should be considered by their physicians when using the valve in this patient population. In addition, patient age should be considered as long-term durability of the valve has not been established. Patients who need a dental procedure should talk to their doctor about risk of infection and needing antibiotics. Patients should be treated post-procedure for heart infection as a precaution.

The safety and effectiveness of the transcatheter heart valves are also not known for patients who have:

Potential risks associated with the procedure include: Additional potential risks specifically associated with the use of the heart valves include:
CAUTION: Federal (United States) law restricts these devices to sale by or on the order of a physician.

Important Risk Information

The Edwards SAPIEN 3 Transcatheter Heart Valve System With The Edwards Commander Delivery System - Important Risk Information for Transcatheter Pulmonary Valve Therapy

The Edwards SAPIEN 3 transcatheter heart valve (THV) system with Edwards Commander delivery system is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (RVOT) conduit or surgical bioprosthetic valve in the pulmonic position with ≥ moderate regurgitation and/or a mean RVOT gradient of ≥ 35 mmHg.

Contraindications (Who should not use):

The Edwards SAPIEN 3 transcatheter heart valve and delivery system cannot be used in patients who:

Warnings: Precautions:

How long the Edwards SAPIEN 3 tissue valve will last depends on many patient factors and medical conditions. Follow all care instructions to ensure the best possible results. The Edwards SAPIEN 3 pulmonic valve has been tested in a laboratory to mimic 5 years of use without failure. Regular follow-ups will help your doctor know how your valve is working.

Potential risks associated with the procedure include:

Death; stroke; risks to the lungs including: difficulty breathing, buildup of fluid in or around the lungs, collapsed lung, loss of lung volume; risks to the heart including: injury to the heart, arteries, heart muscle or valves including the pulmonary RVOT that may require intervention, heart attack, heart failure or heart does not pump properly, irregular heartbeat that may result in a need for a permanent pacemaker, too much fluid around the heart, sudden loss of heart function, disruption or blockage of blood flow through the heart, infection of the heart, injury to your tricuspid valve, additional heart surgery; dislodgement of calcified material, air embolism (air bubbles in the blood vessels), blood clots, or pieces of the device; injury to blood vessels; valve movement after deployment requiring reintervention; transcatheter valve not working properly; life-threatening infection; poor kidney function or failure; abnormal connection between an artery and vein; nerve injury; limited blood supply; severe bleeding requiring transfusion; decrease in red blood cells including at a fast rate; formation of a blood clot; abnormal lab values; high or low blood pressure; allergic reaction to anesthesia or dye; fainting; pain; weakness or inability to exercise; swelling; chest pain; fever

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician

Important Risk Information


For use in replacement of native or prosthetic mitral heart valves.


There are no known contraindications with the use of the MITRIS RESILIA mitral valve.

Complications and Side Effects:

Thromboembolism, valve thrombosis, hemorrhage, hemolysis, regurgitation, endocarditis, structural valve deterioration, nonstructural dysfunction, stenosis, arrhythmia, transient ischemic attack/stroke, congestive heart failure, myocardial infarction, ventricular perforation by stent posts, any of which could lead to reoperation, explantation, permanent disability, and death.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See Instructions for Use for full prescribing information.

Important Risk Information

Edwards PASCAL Precision Transcatheter Valve Repair System
Who can be treated:

The PASCAL Precision transcatheter valve repair system (the PASCAL Precision system) is approved for treating patients with abnormality of the mitral valve leaflets and/or its structure, which may be referred to as Degenerative Mitral Regurgitation or Primary Mitral Regurgitation. Patients should work with their doctor and a specialized Heart Team, which should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, to confirm their surgical risk. The specialized Heart Team will determine if the patient is a suitable candidate for the PASCAL procedure.

Who should not use:

The PASCAL Precision system should not be used in patients who:

Warnings: Precautions:
Precautions Prior to Use Precautions After Use Potential Risks
The most serious risks associated with the procedure are: Additional potential risks include:
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.

Important Risk Information

HemoSphere Monitor
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, Commander, Edwards Commander, Edwards SAPIEN, Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, HemoSphere, Life is Now, MITRIS, MITRIS RESILIA,, PASCAL, PASCAL Precision, PERI, PERIMOUNT, Reach for the Heart, RESILIA, SAPIEN, SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

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