Our work to improve environment, health & safety (EHS) at Edwards supports our culture and Aspiration of passionate engagement that strengthens our communities.
Definition
EHS at Edwards includes our efforts to continuously ensure a safe and healthy workplace, exhibit environmental excellence in our operations and conform to regulatory and industry standards in our work to provide life-saving medical technology products to our patients. Our commitments include initiatives in climate risk, energy and emissions, waste, water and workplace health and safety.
At Edwards Lifesciences, we recognize that safe and environmentally responsible operations bring shared value to our patients, employees, stakeholders and the communities in which we operate. We are committed to providing a safe and healthy workplace by identifying and controlling hazards and risks, minimizing our impact on the environment through pollution prevention efforts, and operating in compliance with legal requirements and applicable standards. Through a culture of engagement and ownership, we will set goals and communicate our progress on a journey of continual improvement.
The EHS Policy applies to all Edwards employees, facilities, activities, products and services as defined within the scope of our EHS management systems.
EHS Management System
We established an EHS Management System in alignment with the ISO 14001 and ISO 45001 management system principles of the Plan-Do-Check-Act cycle and continual improvement. Critical elements of our EHS Management System include:
Establishing an Edwards EHS Policy rooted in our Credo and Aspirations.
Demonstrating leadership commitment to EHS.
Identifying significant risks, opportunities, environmental impacts and health and safety hazards.
Adopting EHS objectives at both corporate and manufacturing plant-levels.
Establishing and implementing systems to maintain compliance, prevent injuries and reduce pollution.
Executing EHS programs, processes and operational controls.
Evaluating performance through internal and third-party audits and management reviews.
Identifying and executing continual improvement opportunities.
Governance
The Compensation and Governance Committee of our Board of Directors has oversight of Edwards’ sustainability efforts, including our environmental policy and its management, and it periodically reviews programmatic progress. Our Chairman and CEO has performance management objectives related to improving our sustainability strategy, performance and disclosures.
ISO certification
In 2016, Edwards set the expectation that by 2023, all of our manufacturing facilities achieve certification against the internationally recognized ISO 14001 Environmental Management System and ISO 45001 Occupational Health and Safety Management System standards. We allow new manufacturing plants three years from date of start-up to achieve these certifications.
Compliance
Complying with EHS laws and regulations in each country and municipality in which we operate is the minimum requirement for us to conduct business. We work to maintain compliance with all applicable EHS laws and regulations through our robust EHS management systems, strong EHS governance and auditing and a culture of employee ownership and accountability. Edwards’ EHS operating model ensures that operational compliance is monitored and reported to senior management on an ongoing basis. We empower employees at every level to take responsibility for, understand and fulfill compliance obligations relevant to their roles. Our EHS experts educate our employees, provide them with the tools to effectively do their jobs and monitor their performance in the spirit of continual improvement.
Energy and emissions
We are committed to reducing our impact on the environment and as such we have an aggressive target to achieve carbon neutrality for our direct operations by 2030 and set and achieve science-based targets. We understand the importance of addressing climate change and are committed to driving a meaningful reduction in our greenhouse gas emissions, even as we continue to grow our business to reach more patients.
As part of our journey toward carbon neutrality, in 2021, Edwards established science-based targets with the Science Based Targets initiative (SBTi) in line with a 1.5°C scenario. Edwards Lifesciences commits to reduce absolute scope 1 and 2 GHG emissions 42% by 2030 from a 2021 base year. Edwards Lifesciences also commits to reduce scope 3 GHG emissions 51.6% per USD of value added within the same timeframe.
We have voluntarily reported our energy and GHG emissions management practices and data through CDP since 2014. For more information, please see our 2022 CDP Climate Change response.
Climate risk
A changing climate brings a range of potential risks to Edwards. We have facilities around the world that face different potential climate-related risks such as hurricanes, droughts and wildfires that could possibly impact our ability to manufacture and transport our products. We identify and assess climate-related risks as part of our integrated approach to managing overall business risk. We have an Enterprise Risk Council, which guides Edwards’ risk management strategy. Led by our SVP of Risk Management and composed of select executive and senior leaders, the Council meets quarterly to conduct a systematic review and mitigation planning for strategic, operational, financial, regulatory, cybersecurity and climate-change risks. The Council periodically reports strategy, key findings and progress directly to the Board of Directors as recommended by the Task Force on Climate-related Financial Disclosures (TCFD) recommendations
We conduct a formal analysis of the likelihood, potential consequence and required response related to various climate transition and physical risks.
Water
Water management is part of our EHS management system. Even though Edwards is a relatively low water use manufacturer, we recognize the importance of using this shared resource efficiently. We focus on water use and discharge within our areas of operational control, including all manufacturing locations and non-manufacturing regional offices.
Most of our water use occurs at our manufacturing sites and these locations annually assess their usage and incorporate appropriate water conservation and protection objectives into annual operating and capital investment plans. Water conservation activities our teams undertake at Edwards’ sites include water-efficient facility design (including LEED certified buildings), low-flow equipment and fixtures, installation of recycling or reuse systems, partnering with local utility providers on water recycling programs and utilizing drought tolerant plants and xeriscape design in our landscape and garden areas.
Company-wide, we regularly assess our water-related risks, which include higher cost of water, water shortages, rationing, fluctuations in water quality and unreliable water delivery in the case of drought or other climate-related changes. We identify opportunities to mitigate water-related risks and reduce our overall environmental impact.
We have voluntarily reported our water management practices and data through CDP since 2014. For more information, please see our 2022 CDP Water Security response.
Water use
Due to the nature of our business, Edwards does not require a significant amount of water in our manufacturing processes, nor do we store a significant amount of water onsite at any of our global locations, except for emergency fire sprinkler water reservoirs and tanks. Most of the water used at our facilities is for manufacturing employee handwashing, personal consumption, cafeteria and restroom use, landscaping and facilities equipment support. We use process water at some manufacturing facilities for production-related equipment and tooling, washing and chemical solutions dilution.
Spill prevention and response
We maintain Spill Prevention and Response programs at all Edwards manufacturing locations. These programs focus on risk identification and engineering, administrative and work practice controls such as secondary containment, double-walled tanks, alarm and notification systems, preventive maintenance, locked valves on fuel-tank containment structures and periodic visual inspections. Our EHS team trains personnel at each site on appropriate spill response and clean-up escalation procedures. We report all spills and releases in accordance with the expectations set by local or country government agencies. In 2022, we had no spills or releases above thresholds that required reporting to government authorities.
We work to protect surface and storm waters in accordance with Edwards’ global EHS Standards as well as with locally issued permits and government regulations. We do not conduct industrial operations in outdoor, storm water-exposed areas. All three of our U.S. facilities in California, Utah and Puerto Rico are covered under No Exposure Certificates (NECs) in accordance with the Environmental Protection Agency (EPA) Clean Water Act. In addition, we employ structural and non-structural source control best management practices (BMPs) at each of our facilities to prevent contamination of storm water.
Waste
Edwards produces solid and hazardous waste throughout our product manufacturing process. As we continue to innovate new and transformational technologies, we work to minimize our waste footprint, contributing to our efforts to manufacture responsibly. As part of our ISO 14001-aligned EHS Management System, our teams annually evaluate local waste volumes and downstream management practices to identify opportunities to reduce, reuse and recycle. We also have well-established programs in place to enable proper storage and handling of regulated waste such as chemicals, batteries and electronics.
While we enable responsible waste management at all non-manufacturing regional offices, the majority of waste we generate occurs at our manufacturing locations. Thus, the focus of our data collection and reporting efforts is on our manufacturing sites.
Health and safety
As we focus on helping patients, we also focus on the safety and well-being of our employees, onsite contractors and guests. Maintaining a strong and healthy workforce enables us to achieve our goals and dedicate energy toward the development of life-saving therapies. To achieve a safe workplace, we maintain robust EHS management systems, strong EHS governance and a culture of ownership and accountability. We recognize building the capabilities of our EHS team is fundamental to the success of our EHS program.
We continue to invest in the development of tools, systems and our team to help achieve our EHS objectives. Our commitment to preventing injury and illness and promoting well-being extends to both manufacturing and nonmanufacturing operations and includes all employees, contractors and visitors at our facilities.
Hazard identification, risk assessment and incident investigation
We use a risk-based approach to manage occupational health and safety, consistent with ISO 45001 principles. The EHS teams at our manufacturing plants work with local supervisors and manufacturing associates to quantify risks associated with various job activities. We regularly conduct a range of risk assessments, such as sitewide safety risk registers, job safety analyses, industrial hygiene risk assessments, ergonomic risk assessments and Hazard and Operability Analysis. When we identify risks above a standard threshold, we implement control measures to eliminate or manage the hazards and risk. We follow the National Institute for Occupational Health and Safety’s Hierarchy of Controls when identifying and implementing safety hazard control measures.
In addition to our regular risk assessments, we encourage all employees to be proactive in identifying hazards in their work areas. Employees are free to report any hazard or concern without fear of reprisal and some of our safety reporting programs allow for anonymous reporting. Edwards’ sites employ various methods to facilitate hazard identification, including safety suggestion boxes, Facilities Help Tickets, Good Saves programs and other near miss and safety concern reporting programs. Local teams also monitor for hazards during facilities reviews, product design review and routine inspections or safety walks.
When EHS-related incidents occur, we require the completion of a thorough investigation to identify the root cause and ensure corrective actions are taken to remove the immediate hazards and prevent a recurrence. The responsible supervisor and manager at the specific site conduct the incident investigations with support from the local EHS team. The incident investigation process may include interviews, a walkthrough of the incident scene, document review and review of surveillance videotape or photos. We clearly communicate with our employees that the purpose of an incident investigation is to prevent a recurrence, not to find fault or assign blame. Our EHS team tracks the corrective and preventive actions introduced based on the findings of the incident investigation to ensure completion.
Employee participation
We use a multi-faceted approach to engage our global employees in Edwards’ safety efforts. We tailor engagement strategies based on country customs and local practice. Key elements of our employee participation efforts include:
Site-level safety committees
Employee suggestion and hazard reporting programs
Process improvement and Kaizen activities
Cross-functional team evaluation of equipment and product lines during design, purchase and validation
Training and awareness
We provide EHS training to employees to support our efforts to comply with all applicable EHS regulations and we educate our employees on safe and environmentally responsible work practices. We use a variety of formats to deliver training material, including instructor-led, web-based, read-and-review and on-the-job training. To encourage active engagement and gauge the effectiveness of the delivery, our training often includes a written quiz, practical examination or worker observation. 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.
The continual development of our global EHS professionals is fundamental to the success of our EHS program. Members of our global EHS team create annual development plans as part of our Talent Development Program. We encourage members of our EHS team to pursue degree and certificate programs, and attend industry conferences, seminars and external training classes. Currently, many of our global EHS professionals hold Lead Auditor certifications in one or both ISO 14001:2015 and ISO 45001:2018, creating a network of internal auditing resources.
Ergonomics
Cumulative trauma illnesses represent approximately 43% of Edwards’ work-related injuries and illnesses. The majority of our cumulative trauma illnesses occur at our valve network manufacturing locations, where manual sewing of tissue valves introduces the ergonomic risk factors of repetition, force and sustained postures. As such, we pursue aggressive strategies in our manufacturing plants and engineering departments that aim to address ergonomic risks with appropriate prevention and control measures throughout the design and manufacturing process, including:
Quantitative risk assessments through detailed video and in-person analysis, ergonomic measurement equipment (e.g., force testing), and an Edwards-developed ergonomic risk assessment tool
Elimination and substitution of high ergonomic risks through automation or redesign during the Product Development Process, based on risk assessment data
Ergonomic manufacturing tools, equipment and fixtures including tissue-holding templates and custom sewing needles
Engineering improvements at the individual workstation level, including ergonomic worktables, chairs and microscopes
Stretching and microbreak programs
Employee ergonomics training and awareness campaigns
Rotation programs organized by operation risk assessment score to ensure manufacturing lines and rotations are evenly balanced
Early injury and illness identification and intervention programs, which include individual ergonomic assessments
Onsite occupational health staff dedicated to providing individual ergonomic support as needed
Occupational health
We believe the well-being of our employees has a direct impact on the success of our company. At each of our manufacturing locations, we provide benefits associated with occupational health commensurate to the worker population, culture and availability of such programs. For example, while all our locations provide access to off‐site medical clinics, our larger locations also employ on‐site nurses and medical professionals to assist in both work and non-work-related injury and personal health needs.
Recent progress
GRI 302-1: Energy consumption within the organization
302-2: Energy consumption outside of the organization
302-3: Energy intensity
302-4: Reduction of energy consumption
302-5: Reductions in energy requirements of products and services
303-1: Interactions with water as a shared resource
303-3: Water withdrawal
303-4: Water discharge
303-5: Water consumption
305-1: Direct (Scope 1) GHG Emissions
305-2: Energy indirect (Scope 2) GHG Emissions
305-3: Other indirect (Scope 3) GHG Emissions
305-5: Reduction of GHG Emissions
305-6: Emissions of ozone- depleting substances (ODS)
306-1: Waste generation and significant waste-related impacts
306-2: Management of significant waste-related impacts
306-3: Waste generated
306-4: Waste diverted from disposal
306-5: Waste directed to disposal
403-1: Occupational health and safety management system
403-2: Occupational Health and SafetyHazard identification, risk assessment, and incident investigation
403-3: Occupational health services
403-4: Worker participation, consultation, and communication on occupational health and safety
403-5: Worker training on occupational health and safety
403-6: Promotion of worker health
403-7: Prevention and mitigation of occupational health and safety impacts directly linked by business relationships
403-8: Workers covered by an occupational health and safety management system
403-9: Work-related injuries
ISO certification
In 2022, our newest manufacturing plant in Ireland achieved ISO 14001 certification one-year ahead of schedule. With this milestone, all Edwards manufacturing facilities are now ISO 14001 certified. In addition, our European Field & Commercial Region also holds ISO 14001 certification. Seventy-one percent of our manufacturing plants are now ISO 45001 certified. Currently, five of our seven manufacturing sites are certified, with our Costa Rica plant recently achieving certification in 2022. The remaining two sites are on schedule to become certified in 2023.
EHS targets
Edwards’ EHS targets are closely aligned with our corporate aspirations and are intended to address topics of greatest importance to Edwards and our stakeholders. We annually reevaluate our goals to ensure they remain relevant and ambitious. As we pursue our patient-focused innovation strategy, we understand the importance of addressing climate change and are committed to driving a meaningful reduction in our greenhouse gas (GHG) emissions. In 2022, we announced our goal to achieve carbon neutrality by the year 2030. Separately, we also announced a commitment to set and achieve SBTi-recognized reduction targets for our combined Scope 1 and 2 emissions as well as Scope 3.
Energy and emissions
In 2022, Edwards achieved a 9% absolute reduction in Scope 1 and 2 GHG emissions over the prior year. This was a significant accomplishment considering the continued growth of our business and global footprint in the same year. We also achieved a 7% reduction in Scope 1 & 2 GHG emissions from our baseline year, without offsets and our upstream Scope 3 GHG emissions held flat per USD gross profit in 2022. This reduction in GHG emissions can be attributed to the diligent efforts of our global team members and a comprehensive approach to carbon emissions that includes:
Aggressive action to reduce energy demand at existing facilities.
Construction of state-of-the-art, zero footprint new facilities.
Strategic transition to renewable energy sources across our global sites.
Purchase of high-quality carbon offsets as a last option for unavoidable emissions.
Reducing energy demand
Annually, each manufacturing plant assesses its energy-related aspects and impacts and incorporates appropriate energy conservation and protection objectives into annual operating plans. In addition, Edwards conducted third-party energy studies in 2021 at our manufacturing facilities in Utah, Puerto Rico and Dominican Republic to identify opportunities to reduce demand. Additional studies were completed in 2022 at our Costa Rica, Ireland and Irvine manufacturing sites, as well as at our Irvine corporate headquarters in 2022. As a result of these studies, more than 20 major facility energy efficiency projects were funded and completed globally in 2022 and additional efficiency improvement projects are planned for future years.
Another key initiative driving improvement in energy efficiency is our approach to facility design and construction. Edwards has implemented a robust, global construction strategy that ensures that all new and renovated buildings are constructed in a manner that minimizes environmental impact, including energy demand and GHG emissions. This approach began in the mid-2010s, with improvements and expansions to our Irvine headquarters and continues with momentum into the construction of our two newest manufacturing plants in Costa Rica and Ireland.
GHG emissions (direct operations)
GHG emissions by scope
Energy intensity
Transition to renewable energy
As we continue on our sustainability journey, we realize the importance of investing in renewable energy. In Costa Rica, over 99% of the electricity from the public utility comes from renewable sources, primarily hydroelectric. In Ireland, our local electricity partner is providing us with 100% renewable energy, primarily from wind energy. Additionally, several of our European sales and field offices are powered by 100% renewable electricity.
At our other global locations, we are actively looking for opportunities to invest in onsite generation of renewable energy. In 2022, solar photovoltaic systems were installed at our Dominican Republic and Costa Rica manufacturing plants, which are anticipated to result in the generation of a combined 2,500,000 kwh of renewable energy per year.
As part of our commitment to achieve carbon neutrality by 2030, we plan to transition to renewable energy sources over the course of the next seven years through both onsite and offsite generation.
Value stream (Scope 3) GHG emissions
In 2021, Edwards completed our first baseline of Scope 3 GHG emissions. In 2022, our Scope 3 GHG emissions were 510,389 MT CO2e, which represents 92% of Edwards’ total GHG emissions. We received independent, third-party verification of our GHG emission data. Recently, Edwards received approval from SBTi on a Scope 3 target, focused on reducing our upstream impact, where the significant majority of our Scope 3 emissions lie, in line with our gross profit growth. In 2022, Edwards’ GHG emissions from upstream Scope 3 sources were consistent, when normalized by gross profit, compared to 2021. Moving forward, our strategy to manage Scope 3 emissions will focus on engaging and incentivizing our suppliers to address emissions from their direct operations through several of our existing supplier management processes. For more information about our Scope 3 emissions, please see the data table.
LEED building certification
Location
Description
Level
Year Certified
Irvine (CA), USA
“Life is Now” Center
Administrative
Gold
2016
Starr Atrium
Administrative
Platinum
2017
Entry Pavilion
Administrative
Platinum
2021
“Dream Big” Complex, PODs 1-5
Research and Development, administrative
Gold
2021
Café & Conference Center
Administrative
Gold
2021
“Dream Big” Complex, PODS 6 & 7
Research and Development, administrative
Gold
2022
Limerick, Ireland
Main plant
Manufacturing
Gold
2021
Cartago, Costa Rica
Main plant
Manufacturing
Gold
2022
Water
In 2022, Edwards’ water withdrawal was 683,487 cubic meters. This represents a 19% increase of absolute withdrawal from our 2020 baseline year, but a 4% reduction when normalized by revenue to account for company growth. This represents a 3% reduction in water withdrawal intensity from the baseline year. In 2022, Edwards had no incidents of non-compliance regarding water withdrawal, use or discharge.
Across Edwards, 85% of our water is provided by third-party public utility providers. Our Singapore manufacturing plant receives 42% of its water from the Singapore government’s NEWater systems. NEWater is high-grade reclaimed water produced from used water treated with UV disinfection and advanced membrane technologies. Edwards is proud to partner with Singapore to utilize this breakthrough and effective technology to provide 12% of Edwards’ total water supply.
We have primarily focused our efforts to reduce water use on incorporating water-efficient equipment and landscaping into our facility design. We also look for opportunities to reuse or recycle water wherever possible to minimize water withdrawal. For example, our Dominican Republic plant recycled 1,294 cubic meters of water in 2022 through onsite water treatment and reuse.
Water-stressed regions
According to the World Resources Institute Aqueduct tool (Aqueduct tool), designed to map global water risk, only our Irvine, California manufacturing plant and corporate headquarters are located in an “extremely high” water stressed region. In 2022, the total water withdrawal at this site was 197,212 cubic meters, with 100% of the water sourced from a third-party public utility. We have several water conservation measures in place at our Irvine location to help manage this risk, including drought-tolerant landscaping, water-efficient fixtures and water reuse systems, such as an underground rainwater harvesting tank.
The Aqueduct tool classifies the location of our Draper, Utah, manufacturing plant as a “low-medium” water stressed region. At this site, we replaced traditional landscaping practices with xeriscaping and artificial turf, and in 2022 piloted a waterless urinal program in order to reduce the facility’s water withdrawal. According to the Aqueduct tool, the remainder of our manufacturing sites are located in “low” stress regions or areas where water stress data are not available.
We do not track local water stress levels for our small and regional offices, as water use volumes for each office are very low and not material on an individual basis.
Waste
In 2022, Edwards generated approximately 5,078 metric tons of total waste. While this represents an absolute increase over our 2020 baseline year, Edwards’ growth has significantly outpaced our waste generation rate. When normalized against revenue, Edwards has reduced its total waste generation by 13.5% against the baseline.
The absolute increase in waste generation in the past year is largely due to our launch of new products and the enhancement of manufacturing equipment and processes, which we initiated in 2018 and continued through 2022. We are required to validate our manufacturing processes to meet stringent FDA and global medical technology quality assurance regulations and this process involves thorough testing of our equipment, procedures and chemicals to ensure efficacy. While validation activities represent growth and a bright future for our business, validation results in an increase in waste disposal without resulting in financial benefit until the products are brought to market.
We continue to identify waste reduction opportunities. In 2022, our manufacturing facilities completed 26 waste reduction or waste diversion projects. These projects included implementation of a new metals recycling program at our Irvine plant, onsite mulching of organic landscaping waste at our Utah plant and introduction of a reusable cup program at our Ireland plant to reduce single-use plastics and disposables. We are proud to note that our manufacturing operations in Ireland maintained zero waste-to landfill in 2022.
Recycling
We recycle hazardous and non-hazardous waste whenever possible. Our primary focus is to reduce the overall generation of waste from our operations and our secondary focus is to identify opportunities to redirect waste to be recycled whenever possible. Due to technological complexities in the different countries we operate in, approximately half of our sites pay to recycle, while the other half receives payment.
In 2022, we recycled 2,140 metric tons of waste. This represents a 42% recycling rate for our total company waste, which is a 7% increase from 2019.
Health and safety
In 2022, Edwards’ recordable incident rate was 0.61 and our lost time incident rate was 0.25, continuing an overall declining trend in work-related injuries over the course of the last several years. This progress contributes to our stated goal to achieve a 35% reduction in recordable incident rate by 2025 from a 2020 baseline year.
Our aspirations
Passionate engagement that strengthens our communities
Excelling as a trusted partner through distinguished quality and integrity
In 2022, Edwards achieved an overall GHG emissions reduction of 8.5%, as compared to the prior year. This result was a product of company-wide efforts to drive energy efficiency and transition to low carbon energy sources. Throughout the year, 16 major energy projects were completed, expected to result in 1,746 MT CO2e emissions avoidance annually. Our renewable electricity mix improved to 39%, from 28% in 2021. Some examples of site projects are highlighted below:
In May 2022, the Irvine campus expansion project was awarded Sustainable Project of the Year by Commercial Real Estate Development Association of Southern California. Every building within the expansion project has or will achieve LEED Gold or Platinum certification and includes sustainable features like high-efficiency mechanical systems and solar photovoltaic (PV).
In addition to installing and commissioning a 1 MW solar PV system in 2022, the Dominican Republic plant completed two notable energy efficiency projects—the installation of solar shades and enhanced monitoring of compressed air systems. These projects are expected to result in an annual savings of over 90,000 kWh in energy and 50 MT CO2e of GHG emissions.
Draper plant completed numerous efficiency projects aimed at saving energy during operational downtime including a weekend RTU motor speed setback, lighting controls and forklift battery station exhaust fan controls.
Highlight story
Designing products with ergonomics in mind
Ergonomics remains one of Edwards’ top employee safety challenges, due to the repetitive and highly manual nature of the valve sewing process. In recent years, Edwards engineers and ergonomic specialists have been partnering to identify and address ergonomic risk early in the product development process. After three years of work, in 2022, Edwards teams completed clinical builds of our first ever, low ergonomic risk heart valve. To achieve this result, the team collaborated with our front-line sewers and identified several risk mitigation strategies including a new sewing needle design, pre-lasered holes, high-risk stitch removal and sewing fixtures.
Highlight story
2022 LEED Gold certification achievement
We are proud to share that in 2022, our Costa Rica Plant officially received LEED Gold certification. The Costa Rica Plant was constructed in 2018 with an environmentally efficient design, operating on 100% renewable electricity. In the last 4 years, additional features and improvements have been made, allowing the facility to earn the “points” necessary to meet the green building standards required for the prestigious LEED Gold certification. Costa Rica joins our Ireland manufacturing plant this year as our second LEED Gold manufacturing facility.
Costa Rica Plant
Important Risk Information
Edwards SAPIEN 3, Edwards SAPIEN 3 Ultra, and Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System
Indications:
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:
Cannot tolerate medications that thin the blood or prevent blood clots from forming.
Have an active infection in the heart or elsewhere.
Have a mitral ring that is damaged and can no longer support the valve.
Warnings:
There may be an increased risk of stroke in transcatheter aortic valve replacement procedures, compared to other standard treatments for aortic stenosis in the high or greater risk population.
If an incorrect valve size for your anatomy is used, it may lead to heart injury, valve leakage, movement, or dislodgement.
Patients should talk to their doctor if they have significant heart disease, a mitral valve device or are sensitive to anesthesia, contrast media, cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
The Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves may not last as long in younger patients, or patients with a disease that results in more calcium in their blood.
During the procedure, your doctors should monitor the dye used in the body; if used in excess it could lead to kidney damage. X-ray guidance used during the procedure may cause injury to the skin, which may be painful, damaging, and long-lasting.
Patient’s creatinine level should be measured prior to the procedure.
Patients who have already had a valve replaced should be carefully assessed by their physician prior to receiving a new valve to ensure proper placement of the new valve.
Injury can occur if the delivery system is not used properly.
Transcatheter heart valve patients should talk to their physicians about the potential need for medications that thin the blood or prevent blood clots from forming. Patients who do not may be at increased risk of a stroke. Blood-thinning medication may increase the risk of bleeding in the brain (stroke).
Transcatheter valve replacement is not recommended in previous mitral valve rings that are damaged or have become too rigid.
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:
An aortic heart valve that is not calcified, contains only one leaflet, has leaflets with large pieces of calcium that may block the vessels that supply blood to the heart or in which the main problem is that the valve leaks.
Who have a prosthetic ring in the tricuspid position.
A heart that does not pump well, has thickening of the heart muscle, with or without blockage, unusual ultrasound images of the heart that could represent irregularities such as a blood clot, a diseased mitral valve that is calcified or leaking, or Gorlin syndrome, a condition that affects many areas of the body and increases the risk of developing various cancers and tumors.
Low white, red or platelet blood cell counts, or history of bleeding because the blood does not clot properly.
Diseased, abnormal, or irregularly shaped vessels leading to the heart. Vessels which are heavily diseased or too small for the delivery devices, or a large amount of calcification at the point of entry.
Allergies to blood-thinning medications or dye injected during the procedure.
Whose previously implanted artificial valve or ring is not securely in place or is damaged that could cause it to leak.
Whose previously implanted valve or ring could block a blood vessel caused from the leaflet partially detaching.
Potential risks associated with the procedure include:
Death, stroke, paralysis (loss of muscle function), permanent disability, or severe bleeding.
Risks to the heart, including heart attack or heart failure, sudden loss of heart function, a heart that does not pump well, irregular heartbeat that may result in a need for a permanent pacemaker, chest pain, heart murmur, false aneurysm, recurring aortic stenosis (narrowing), too much fluid around the heart, injury to the structure of the heart.
Risks to your lungs or breathing, including difficulty breathing, fainting, dizziness, buildup of fluid in or around the lungs, weakness, or inability to exercise.
Risks involving bleeding or your blood supply, including formation of a blood clot, high or low blood pressure, limited blood supply, a decrease in red blood cells, or abnormal lab values, bleeding in the abdominal cavity, collection of blood under the skin, serious damage to the arteries, severe bleeding in the heart or in the body that could require a transfusion or surgery.
Additional risks, including life-threatening infection, dislodgement of calcified material, air embolism (air bubbles in the blood vessels), poor kidney function or failure, nerve injury, fever, allergic reaction to anesthesia or dye, reoperation, pain, infection, or bleeding at incision sites, or swelling.
Additional potential risks specifically associated with the use of the heart valves include:
Valve movement after deployment, blockage or disruption of blood flow through the heart, need for additional heart surgery or emergency heart surgery and possible removal of the Edwards SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA and SAPIEN 3 valves, a blood clot that requires treatment, damage to the valve (e.g., wear, breakage, recurring aortic stenosis), valve issues not related to structure (e.g., leakage, inappropriate sizing or positioning, blockage, excess tissue in growth, blood cell damage) or mechanical failure of the delivery system and/or accessories.
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
Indications:
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:
Cannot tolerate medications that thin the blood or prevent blood clots from forming.
Have an active infection in the heart or elsewhere.
Warnings:
If an incorrect size of the valve is implanted, it may lead to valve leakage, movement, or dislodgement of the valve from where it was implanted, residual gradient and/or tearing of the conduit
Patients with a disease that results in more calcium in their blood may have early wear of their valve.
Patients should be evaluated prior to treatment for coronary compression risk.
Talk to your doctor if you are allergic to the materials used during the procedure: cobalt, nickel, chromium, molybdenum, titanium, manganese, silicon, and/or plastics.
X-ray used during the procedure may cause radiation injury to the skin.
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.
Patients should be pretreated for heart infection as a precaution.
Transcatheter heart valve patients should stay on blood-thinning medicine as specified by their doctor.
Patient’s anatomy should be evaluated prior to procedure to prevent the risk of patient not being able to receive the valve.
The safety and effectiveness of the transcatheter heart valve have not been established for patients who:
Have a disease or disorder of the blood (low white or red blood cell count, low platelets or history of slow blood clotting)
Have an allergy to blood-thinning medications or dye injected during the procedure
May be pregnant
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
MITRIS RESILIA Mitral Valve
Indications:
For use in replacement of native or prosthetic mitral heart valves.
Contraindications:
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:
Cannot tolerate certain blood thinners during or after the procedure
Have an untreatable allergy to nickel, titanium or X-ray contrast media
Have an active infection of the mitral valve (endocarditis)
Have mitral regurgitation caused by rheumatic disease
Have evidence of blood clots in the heart or veins leading to the heart
Warnings:
Serious complications, sometimes leading to surgical intervention and/or death, may be associated with the use of this system. Talk to your doctor for a full explanation of the benefits and risks associated with this procedure.
As with any implanted medical device, there is potential for an adverse allergic or immunological response.
Careful and continuous medical follow-up is advised so that any complications can be diagnosed and properly managed.
Blood thinning medication will be determined by your doctor per standard guidelines.
The PASCAL Precision system has not been evaluated in pregnant women or children.
Precautions: Precautions Prior to Use
Your heart team will do an assessment to decide if you are a suitable candidate for this procedure.
Precautions After Use
Follow all care instructions to ensure the best possible results. Regular follow-up is advised to evaluate the performance of your device.
Short-term blood thinning medication may be necessary after valve repair with the PASCAL Precision system. Your doctor should prescribe this and other medical therapy per standard guidelines.
Potential Risks The most serious risks associated with the procedure are:
Death.
Stroke
Serious bleeding
Unplanned repeat procedure or surgery
Additional potential risks include:
Abnormal heart rhythms or cardiac arrest, which may require a pacemaker
Abnormal low or high blood pressure
Allergic reaction to anesthetic, contrast, heparin, Nitinol (Nickel and Titanium) and/or other medications
Aneurysm or pseudoaneurysm
Bleeding, stomach bleeding, hemolysis, or decreased blood count, which may require transfusion
Blood clots in the legs (Deep Vein Thrombosis)
Blood clots, particles, catheter fragments or air in the blood vessels, lungs, body or brain
Cardiogenic shock
Chest pain
Damage or puncture of the heart or blood vessels that may require surgery
Damage, injury to, narrowing, or tearing of the mitral valve or other valve structures
Damage to the swallowing passage (esophagus), with possible puncture or narrowing
Dislodgement of a previous implant
Failure to retrieve any PASCAL Precision system components
Fever or infection, including of the heart valveg
Fluid or blood around the heart or lungs
Heart attack
Implant deterioration (wear, tear, fracture or other), malposition, clotting, movement or embolization
Kidney failure
Lab values that are not normal
Nerve injury, paralysis or neurological symptoms, including problems with movement or walking
Organ failure, including heart failure
Pain
Respiratory compromise that may require prolonged need for a respirator
Shortness of breath, fainting or dizziness, nausea and/or vomiting, swelling, weakness, diminished exercise ability
Skin burn, injury or tissue changes due to exposure to X-rays
Single leaflet device attachment (SLDA)
Vascular injury or trauma, including decreased blood flow, dissection or occlusion
Worsening of valvular insufficiency
Wound healing infection or slow healing
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, NewHeartValve.com, 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.