Sustainability report

Diversity, inclusion & belonging

Through our diversity, inclusion, and belonging initiatives, we aim to broaden the perspective we use while also attracting and developing talent; educate and engage our employees; and better meet the needs of our customers and patients. We are committed to fostering an inclusive culture where all employees grow and thrive.

Definition

At Edwards, we define our diversity, inclusion and belonging initiatives as those that promote diversity in company leadership, our employees overall and among our suppliers. This topic also includes our efforts to foster an inclusive culture and provide fair pay and equal opportunities for all employees, regardless of their background.

Our aspirations

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Fostering an inclusive culture where all employees grow and thrive

Material topics
Highlight story

Global Diversity Inclusion and Belonging Day

In 2022, Edwards hosted its annual Global Diversity Inclusion and Belonging Day for all employees where they heard about DI&B initiatives and the impact on the culture employees experience every day at Edwards. In addition to hearing from leaders across the organization, the Edwards $100 million Social Impact Investment Fund initiative was featured, and employees heard from a special guest speaker, Hilda Kennedy, Founder and President of AmPac Business Capital. AmPac is a mission driven lender dedicated to advancing entrepreneurial dreams through financing and fostering business success. Edwards has partnered with AmPac providing capital investments to support small business owners in underserved marginalized communities. Through this partnership we provide capital to support down payment assistance to create jobs and wealth building opportunities, all while focusing on our shared value of improving quality of life. For example, in September 2022, AmPac funded it’s fourth “It Is Possible” Down Payment Assistance Loan for Ramon Soto and son, who own a custom furniture company. The loan assisted the Soto’s with financing a larger warehouse space to accommodate growth and enable the creation of 15 new jobs in a predominantly minority community. “Small businesses are truly the heart of economic development in our country. And AmPac is delighted to help these small businesses own commercial property, further elevating the economy,” said Hilda Kennedy, President of AmPac Business Capital.

Highlight story

Edwards partnership with LIFEvest

Edwards was honored to partner with The UCI Center for Investment and Wealth Management and PacificLife’s LIFEvest program in 2022.

This program empowers underprivileged high school students throughout Orange County to further their education as a pathway to a job providing the opportunity for economic independence. During the one-week program the students learned real-life financial skills and what it takes to get accepted into college. These students typically do not have a role model working in a corporate environment and would likely be the first in their families to attend college.

Edwards hosted 80 students on campus in June and July 2022. Presenters included finance employees along with our CFO, and during lunch, more than 40 leaders from across the company sat with the students to speak one-on-one and answer their questions. The students also experienced a tour of our campus, including the manufacturing facility, and concluded the day with a patient video. Many students commented they were surprised how a corporate setting could be so fun and meaningful. We are inspired by these students who continue to pursue their dreams.

Highlight story

Diversity Inclusion and Belonging Career Day

In 2022, Edwards organized a Diversity Inclusion and Belonging Career Day, during which we invited 30 middle school students from the Boys and Girls Club of Central Orange Coast to our Irvine, California, campus for a half-day filled with fun and insightful perspectives on the many different paths within science, technology, engineering, arts and mathematics (STEAM). During the event, we hosted a panel discussion featuring leaders from teams across Edwards, took the students on a tour of our campus and conducted a STEAM workshop. As a part of our larger strategy to drive diversity, inclusion and belonging, we look for ways to cultivate curiosity within young minds by providing kids with the experiences and exposure they need to look at the world in new ways.

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:

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
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:

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

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:

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, 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.

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