Edwards Lifesciences and COVID-19

While the full impact of COVID-19 on Edwards and our stakeholders will not be known for some time – and will certainly be discussed within the 2020 sustainability report next year – it is important to acknowledge how Edwards’ commitments have been influenced or heightened by the global pandemic.

The global response by Edwards’ clinician partners on the front lines of the evolving situation with COVID-19 has demonstrated strong leadership and a brave commitment. At the same time, Edwards’ incredible employees each day have continued their work. At the outset of the global spread of the virus, almost one-third of Edwards’ employees converted to remote work, transitioning our global office operations to virtual platforms almost overnight. Thousands of Edwards’ manufacturing employees continued coming to the company’s facilities around the world with extra safety precautions, to ensure the development, manufacture and delivery of our life-saving technologies to patients in more than 100 countries. The unwavering commitment of our global manufacturing employees means that structural heart patients with urgent needs have been able to receive treatment, and that the increasing number of critically ill patients have been able to be closely monitored at a time when it was needed most. We also have teams providing their support in health care facilities around the world, living our Credo: Helping Patients is Our Life’s Work, and Life is Now. In addition to sharing details about this response on our quarterly earnings call in April 2020, Edwards’ CEO also discussed it with the local business publication, Orange County Business Journal.

We are grateful to all of those in the global healthcare community responding to the needs of patients impacted by COVID-19. Edwards has published two letters in response to the ongoing global pandemic to detail some of the steps the company has taken to support employees, communities and patients, both in the short-term COVID response, and also to ensure the long-term resilience and sustainability of the company. Our risk management and business continuity planning helped provide important foundations for how to approach our company response related to COVID-19, but given the rapidly changing – and still changing – nature of what is happening around the world, it has been critical for us to maintain agility and stay in constant communication with our employees throughout.

Edwards, like others, has taken many important steps to guard against the community spread of COVID-19. We have relied on trusted health authorities, governments and local hospital policies to inform our decision-making. We implemented important measures at our facilities worldwide to ensure the safety of our employees, while also continuing our critical work in providing life-saving technologies for patients. The measures have included enhanced cleaning procedures, physical distancing in common areas at campuses, staggered work schedules and flexible, remote schedules and providing personal protective equipment such as face coverings or face masks to our employees both at our facilities and for those working in clinical settings.

For those employees who have been impacted by COVID, Edwards offers support in the form of a case manager who stays in close contact with the employee to ensure their health needs are being addressed.

We also recognize the important role and impact of Edwards’ charitable partners in meeting both local and global community needs amidst the pandemic. To respond to these needs, Edwards Lifesciences Foundation took action quickly to issue $1 million in emergency community grants to partner organizations serving on the front lines of COVID-19 and providing safety net services such as financial assistance for food, medication and rent to vulnerable communities where Edwards’ employees live and work around the world. Additionally, Edwards provided donations of critical care technologies during this crisis to help underserved patients around the world.

At our headquarters campus in Irvine, Calif., we continued the pay for our on-site café staff, even during periods where the numbers of Edwards employees on campus did not require a full staff to prepare meals and some of the staff stayed home. As needs in our community to address hunger became more evident, we engaged our café staff to prepare to-go meals for donation to local charitable organizations serving the homeless and hungry. Between April and July 2020, Edwards provided more than 20,000 meals to organizations including Mercy House: LINK, Mercy House: Costa Mesa Bridge Shelter and Illumination Foundation. The Orange County Register provided additional information on those receiving the meals. For those employees dining on campus, meals were provided free of charge or for a donation to the Second Harvest Food Bank. We continue to stay closely connected to our charitable partners to understand other ways we can help our communities.

As the pandemic continues to impact healthcare worldwide, we have concern for many patients in the areas we serve, such as those affected by heart valve disease, that are not getting treated. The reasons are varied and include fear of seeking treatment because of risk of COVID-19 in their communities, inability to get treated because procedures are being cancelled due to the strain on hospital resources or for personal economic reasons, such as job loss or lack of insurance coverage. We know that COVID-19 is deadly and has created tremendous strain on the health care system globally. But, sadly, we expect that because of this strain and associated treatment delays, some valve disease patients will worsen and not survive the delay, given the deadly nature of these chronic conditions. This is a very difficult time for structural heart patients and their doctors as they weigh the risk of COVID-19 versus the underlying progressive disease, and a number of organizations have helped to provide information to educate them as they seek care. We are committed to working together with our clinician partners, employees, governments and communities to do what we can to address this global health crisis.

We are fortunate that Edwards is a strong company and our priorities have been to focus on keeping our employees safe and helping patients and customers in need, and we have been able to continue our patient-focused innovation work around the world. We have continued hiring for our open positions globally and are focused on maintaining global supply because of the critical nature of our work. We are also working with others in our industry to identify opportunities for us to work together to impact patient care and support the needs of smaller innovators in medical technology. The dedication and passion of our employees is particularly admirable in this challenging time, and we are grateful for their commitment to serving patients and their communities, affirming their dedication to our collective work for patients, improving and enhancing lives.

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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