At Edwards, we focus on continually innovating and improving our approach to employee recruitment, engagement and retention to foster an inclusive culture where all employees grow and thrive.
Definition
We consider the topic of human capital management (HCM) to include our strategies for attracting, developing and retaining talent; how we build and maintain our culture; fostering a diverse and inclusive workplace; and promoting workplace health and safety.
GRI 401-2: Benefits provided to full-time employees that are not provided to temporary or part-time employees
Our employees unite around a shared passion for improving the lives of patients. Based on that shared passion, our top priority as a team is to work with precision and care because e know our products and services can impact the longevity and quality of life of our patients. As Edwards continues to grow, we prioritize maintaining and scaling our culture because it is an important factor in aligning our strategy to attract and maintain a motivated, professional workforce and to ensure alignment on our patient-focused innovation strategy.
Governance
Our Board of Directors routinely engages with leadership to review and discuss our HCM, with time dedicated at each regularly scheduled meeting to discuss talent management, which include topics such as talent strategy, diversity, succession planning, employee development, employee health, safety, and welfare, results of employee surveys and compensation. Our Chief Executive Officer and his leadership team have talent management related performance goals tied to their compensation; these goals are reviewed on an annual basis, tracked and then reported to and evaluated by our Board of Directors.
We believe to best help our patients, we must also support the well-being of our employees. Maintaining a healthy workforce enables us to focus on our business goals and dedicate energy toward the development of lifesaving products and services. As we continue to grow globally, we aim to recruit, retain and develop talent who can help Edwards thrive in the fast-changing medical technology industry.
Patients First culture
Investing in our workforce means our employees can remain attentive to our patient-focused innovation strategy and the development of life-saving therapies for the patients we serve. We are committed to maintaining an ethical culture where we celebrate diversity and belonging, promote good health and safety, empower employees to speak up and ensure that employees’ voices are heard. We strive to offer competitive employee well-being packages and are committed to fair and equitable pay practices. We track compensation patterns in all geographies where we operate, and we regularly look for ways to ensure fair and equitable pay.
We are proud of our “Patients First” culture and look for ways to ensure our entire employee population feels connected to this focus. One way we do this is by regularly providing opportunities for each employee to engage on patient stories and patient interactions. By keeping patient stories top of mind, we look to improve employee engagement and remind our team that the work we do makes a real difference in people’s lives. We share patient videos and testimonials during the CEO-hosted quarterly employee meetings, team meetings presented by Edwards leaders and as part of our standard new hire orientation.
People strategy
As we scale to reach more patients around the world, we have integrated our Talent and Organization (T&O) Strategy with our Edwards Strategic Planning process. The purpose of our T&O Strategy is to anticipate dynamic global trends related to our workforce, develop our talent to meet future organizational needs, and enable us to be well-poised to meet these needs. Our T&O Strategy enables us to explore external workforce signals, share insights and identify and build emerging capabilities across our organization. This has resulted in a comprehensive succession planning process that allows us to build strong talent from within, while we pursue a strategic recruiting process to fill any gaps with highly qualified external talent. This consistent and scalable approach looks across all our product groups, regions and significant functions to align and elevate priorities, critical capabilities and organizational evolutions in line with our strategic plan. This integrated approach informs our yearly objectives and fuels our talent roadmap across the strategic horizon.
It is the policy of Edwards not to discriminate or allow the harassment of employees or applicants on the basis of sex, gender identity, gender expression, sexual orientation, age, race, color, religion and many other characteristics. For more information, please see our Equal Opportunity Policy.
Recruiting top talent
We aim to attract and retain a motivated workforce connected by our culture of patient-focused innovation. Part of our strategy for attracting top talent is to offer competitive compensation and benefits packages, which include performance-based incentives, stock-based compensation, retirement plans, remote work where applicable, paid time off, family leave, and health, life, and disability insurance. We have a retention target of achieving an annual voluntary turnover rate that is lower than high-performing benchmarks.
Edwards has established a long-term aspiration to grow and develop talent, centering our efforts around critical leadership and technical skills for the present and future needs of the business. Our learning and development structure and processes strive to meet the internal demand to develop our talent in such a way that demonstrates impact at scale and delivered to our workforce through optimized learning modalities. We offer a range of programs to help employees deepen and expand their knowledge, including:
Technical Centers of Excellence and informal learning communities of practice focused on enhanced technical capability and skills development.
An online platform, Edwards University, through which our employees can access training on a wide variety of topics, and leverage partnerships with the University of California, Irvine; eCornell; MIT; and Mind Tools.
A global leadership development curriculum, Aspire, covering areas such as critical thinking, strategic execution, effective conversations, communicating among different personalities, leveraging diversity and emotional intelligence.
Several nomination-based programs, including the Accelerated Development Program, designed to build leaders for the future by offering employees challenging programming, coaching and assessments.
A career development site that houses all of our tools regarding future-focused development and a framework for both leadership capabilities and technical skills for the future.
Tuition assistance for job-related continuing education and degree programs.
Talent Development Review
Our HCM governance includes a global Talent Development Review (TDR) process led by our Director of Talent Management. We leverage the TDR process to align our business strategy with talent strategies, assess the talent against future organizational needs, evaluate critical talent populations and enhance the strength of our succession planning. We use a dashboard to track key human capital metrics and generate a quarterly snapshot, which our team uses to analyze attraction and growth rates, retention trends, diversity and employee sentiment. Annually, our CEO meets with the Chief Human Resources Officer and the CVP of each business unit, function and region to review their respective talent needs for the upcoming years.
Mentoring programs
We offer several mentoring programs across Edwards to help facilitate deeper employee connections, build internal talent, share knowledge and increase workforce engagement and satisfaction. Over the years, we have seen a strong connection between participation in mentorship programs and employee retention. Flash mentoring and peer-to-peer mentoring are also being utilized to drive development through less formal, more rapid mentoring connections.
Total Well-being
At Edwards, we believe that if employees take care of their physical, mental, financial and emotional health, they can bring their best selves to the workplace. We offer competitive employee well-being packages that include, among other things, health and wellness insurance, health savings accounts, family support services and a variety of site-specific programs. For example, our U.S. well-being screenings include a metabolic health panel and a range of on-site programs that target overall well-being for our employees. Our team regularly reviews all benefits and well-being programs to make modifications that are aligned with the competitive landscape, legislative changes and the unique needs of our population, and makes recommendations to our Administrative and Investment Committee for their review and approval.
To meet the needs of our employees, we provide robust well-being programs that address our pillars of prevention, nutrition, mental health, physical activity, financial fitness and community service. These pillars align with our employee population health priorities: Mind+, metabolic health and musculoskeletal health, as well as heart health, which supports Edwards’ corporate focus. We leverage a multi-year strategy to address these priorities by offering thoughtful programming such as educational outreach and activities.
In recent years, mental well-being has become a central topic for organizations worldwide. As part of our regular evaluation and commitment to putting employees first, we launched a new program, Mind+, which offers a wide variety of mental well-being programs for our employees. This commitment extends to creating a work environment where employees can feel confident speaking about mental well-being with their managers and know how best to access the tools and resources available to support them. We believe there are strong benefits when employees are feeling their best. Employees who are mentally healthy are more innovative, resilient, better decision-makers and able to build stronger relationships. We also believe that prioritizing and promoting Mind+ allows us to help patients around the world to live longer, healthier and more productive lives and supports employees to be their best selves at home and at work.
Community
We offer several of our well-being programs globally, including the Global Movement Challenge, which inspires employees to engage in physical activity and connect with one another. For this challenge, we partner with Walkingspree, a digital app that employees can use to set step goals, track steps, log activity, challenge co-workers and earn prizes. While participating employees exercise, the Walkingspree app records progress through their cellphones or fitness trackers. Individuals earn points for partaking in different activities and achieving program milestones. The camaraderie and competitive fun of participating in themed challenges – such as Earth Day, St. Patrick’s Day or World Cup – and tracking results against co-workers produces a ripple effect. In 2022, 78% of participating employees walked more than the average American, which is about 3,500 steps per day. As a group, our steps add up to the equivalent of walking around the world 182 times.
Additionally, many employees at various locations take it upon themselves to create camaraderie while doing something good for their community, like participating in local events, making care packages and coordinating donations for an important cause.
Recent progress
GRI 3-3: Management of material topic
Ongoing COVID-19 response
Since the COVID-19 pandemic began to spread globally in 2020, we have acted with flexibility and resilience to protect our employees and continue developing and delivering lifesaving products for patients in need. We recognize that the health and safety of our employees is critical to the success of the business and have implemented several measures to protect our global workforce. In 2022, our SVP of Employee Health led our efforts to include a combination of global and local strategies tailored to the specific needs and circumstances of each region, while maintaining consistency in our approach to health and safety. Throughout the pandemic, as conditions changed, we implemented travel restrictions and quarantine protocols, as well as guidelines for large meetings, remote work and flexible scheduling. We have also provided training and resources to our managers to help them effectively support their teams in navigating the ongoing impacts of the pandemic.
We continue to monitor the situation and adapt our global response plan as needed to ensure that we are keeping our employees safe, while maintaining business continuity. In 2022, we continued to provide case management support for COVID cases among our global workforce. In addition, we frequently communicated with employees through channels such as additional townhall and question and answer sessions during the peak of the outbreak in China. We also continue to regularly disinfect our workspaces, maintain high quality air filtration in our facilities and provide access to resources related to mental health, stress, Long COVID and vaccinations. The SVP of Employee Health regularly updates the ELT, plant leaders and the Enterprise Risk Management team on the latest variants, regional surges and emerging science on the virus. We remain committed to monitoring the ongoing impacts of the pandemic to ensure the safety and well-being of our employees.
Employee engagement
We are dedicated to making positive contributions in our communities, and we encourage our employees to participate in charitable events and use our company matching donation program. Of those who responded to our 2022 global employee engagement survey, 86% reported participating in charitable activities within the past 12 months. We are proud of these results, and the progress toward our annual goals of 100% global employee participation in a charitable activity, 100% SLT participation in a charitable activity and a year-over-year increase in global participation as measured by the employee engagement survey.
In addition to the positive impact on our communities, we have identified a relationship between participation in charitable activities and favorable employee perception of Edwards as an employer. Those who participated in charitable activities reported higher sentiments of engagement than those that did not participate. Also, those that participated in charitable activities also reported higher levels of patient focus, culture and belonging. These results support our target to have a highly engaged workforce that meets or exceeds industry, region, and high-performing benchmarks for employee engagement. For more information about employee volunteerism and engagement, please see our Volunteerism & Giving section.
Patients First
We regularly highlight patient stories and facilitate patient interactions with employees through both in-person and virtual meetings at our regional headquarters and at manufacturing facilities around the world. We rely on regional leaders to help us compile an estimate of the total number of employees who are exposed to patient stories on an annual basis. We believe that in 2022, all of our global employees experienced at least one patient story, and we believe many of these individuals had the opportunity to interact with multiple stories or patient speakers. In our 2022 employee survey, 93% of respondents agreed that at Edwards, we consider what is important to patients when making decisions. Examples of “Patients First” activities we host on an ongoing basis include:
An annual training meeting for field personnel which include patient stories and/or in-person patient testimonials as a formal agenda item.
During regional all-employee meetings, we show patient videos and on occasion arrange panels featuring physicians and local Edwards representatives to discuss the patient experience.
Based on job responsibility, we provide certain employees at our regional offices and manufacturing facilities with time away from their roles to attend the employee meetings where we feature patient stories.
We showcase patient testimonials on our online platforms, such as NewHeartValve.com and ReachForTheHeart.com.
We leverage our internal website, Dose of Edwards Goodness, to share uplifting stories from Edwards colleagues and patients around the world.
At several of our regional offices and manufacturing facilities, we conducted Patient Experience events where we host patients and their caregivers to learn from their healthcare experience and interact directly with our employees.
Training and leadership development
In 2022, we expanded our existing leadership development programs, including individualized coaching, remote worker training, exploring leadership for individual contributors and webinars and live development sessions. We continue to see an increase in promotion rates for those participating in coaching activities as well as positive business impacts overall. For example, through our Technical Development Program and University Engineering Program in 2022, 47% of eligible candidates were hired for full-time positions with a 90% offer acceptance rate. Also in 2022, we observed that individuals we hire through the Technical Development Program and the University Engineering Program have a combined retention rate of 82%.
In 2021, we launched the Accelerated Development Program, which provides the opportunity for select employees to accelerate their leadership capabilities through targeted development and executive support. The program also includes a charitable leadership element that is focused on linking future leadership behaviors with our patient-focused culture and innovation-focused business strategy. In 2022, we designed a six-step process for future-focused development, which is available through our intranet, to provide employees with tools and resources to help them drive their professional growth. We plan to formally launch the corresponding site in 2023.
Mentoring programs
In 2022, we continued to offer opportunities in traditional, flash, speed and circles mentoring. Mentoring is also embedded in other development opportunities, such as the Accelerated Development Program. These additional modes of mentoring allow employees to receive guidance and support in a way that better suits their preferences and time constraints.
Total Well-being
We are on an ongoing journey to better understand the health needs of our employees and support them in proactively managing their well-being. We offer U.S. employees access to a free annual biometric screening, which now includes a metabolic health panel, to provide them with a convenient way to monitor their key health indicators and identify any emerging concerns.
In addition, at each of our seven global manufacturing sites, we provide benefits associated with occupational health specific to the employee population, culture and availability. We are proud to offer a range of holistic benefits to our employees, including smoking cessation programs, health coaching and an employee assistance program, among others. At some of our locations, we offer on‐site fitness centers, basketball courts, cycle-to-work amenities and large fields for soccer and other outdoor activities. At our headquarters in Irvine, we also offer an on-site health clinic and services.
The results from our recent employee engagement survey signal that a majority of employees find value in the well-being programs and resources we offer.
U.S. Well-being
Between June 2021 - June 2022
U.S. Employee Participation in Biometric Screenings
93%
U.S. Employees Enrolled in an Edwards-Sponsored Medical Plan
89%
Health Costs Per Employee Per Year (PEPY)
12.6% under market PEPY
Our aspirations
Fostering an inclusive culture where all employees grow and thrive
Now more than ever, mental and physical well-being are critical to having a healthy workforce. We believe that mental well-being is as important as physical health; in fact, the two are interconnected. Mental well-being includes emotional, psychological and social well-being, and it affects how employees think, feel and respond to life’s stressors.
We continue to evolve our physical and mental well-being programming to ensure we are meeting employees’ needs. Our Mind+ initiative, launched in 2021, has greatly helped us elevate the conversations around mental well-being.
One example of a Mind+ program is the leader video series, which features Edwards’ senior leaders discussing what mental well-being means to them. These leaders openly share real examples in their lives of how they think about mental well-being, tactics to nurture it, times they grappled with stress or well-being and how they recommend focusing on their own and colleagues’ mental health.
Videos are shared regularly with employees, along with other educational resources available to support their mental health. In 2022, we revamped the video format to continue to build engagement with employees.
Les Mills workouts through Walkingspree
With the launch of the Global Movement Challenge through Walkingspree, we provided a unique way for employees to move their bodies. In 2022, we offered another option to move more with the addition of on-demand workouts from Les Mills. Employees can access a range of workouts regardless of their fitness level. All they have to do is search for the workout of their choice, press play and get moving from wherever they are, whenever they want. Plus, each workout they complete counts towards points they earn for the Global Movement Challenge in the Walkingspree app.
Mind+ Well-being guides
Through our Mind+ program, we offer employees access to a Well-being Action Plan to help individuals better care for their well-being and make improvements by committing to true behavior changes. The downloadable PDF is designed to be a tool that employees write in, refer to and adjust as they move along in their well-being journey. The action plan also features a list of Edwards resources that are designed to help employees take better care of their mental well-being.
In addition to the Well-being Action plan, we offer the Mind+ Employee and People Leader Guides. These resources provide guidance around mental well-being, how employees can care for their own mental health, how they can have conversations about it, how they can check in on one another, how to recognize if coworkers need support, and how managers can navigate these conversations with their employees. These are valuable resources in elevating and normalizing conversations about mental well-being at Edwards.
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.
