Edwards Lifesciences Stock
About Edwards Lifesciences
Edwards Lifesciences Corporation operates as a manufacturer of heart valve systems and repair products used to replace or repair a patient's diseased or defective heart valve worldwide.
The company’s work in heart valves encompasses both surgical and transcatheter therapies for heart valve replacement and repair. In addition, its robust pipeline of future technologies focuses on the less invasive repair or replacement of the mitral and tricuspid valves of the heart, which are more complex and more challenging to treat than the aortic valve that is the focus of many of its commercially approved valve technologies. The company is also a global leader in hemodynamic and noninvasive brain and tissue oxygenation monitoring systems used to measure a patient's cardiovascular function in the hospital setting.
Product and Technology Offerings
The following are the main areas of products and technologies the company offers to treat advanced cardiovascular disease. Its products and technologies are categorized into four main areas, such as transcatheter aortic valve replacement, transcatheter mitral and tricuspid therapies, surgical structural heart, and critical care.
Transcatheter Aortic Valve Replacement
The company is the global leader in transcatheter heart valve replacement technologies designed for the minimally-invasive replacement of aortic heart valves. The Edwards SAPIEN family of valves, including Edwards SAPIEN XT, the Edwards SAPIEN 3, and the Edwards SAPIEN 3 Ultra transcatheter heart valves, and their respective delivery systems, are used to treat heart valve disease using catheter-based approaches for patients who have severe symptomatic aortic stenosis and certain patients with congenital heart disease.
The company offers its transcatheter aortic heart valves to patients commercially in Europe, the United States, and Japan. Supported by extensive customer training and service, and a growing body of compelling clinical evidence, its SAPIEN family of transcatheter aortic heart valves are the most widely prescribed transcatheter heart valves in the world.
Transcatheter Mitral and Tricuspid Therapies
The company continues to make significant investments in the development of transcatheter heart valve repair and replacement technologies designed to treat mitral and tricuspid valve diseases. While many of these technologies are in development and clinical phases, the PASCAL and Cardioband transcatheter valve repair systems are commercially available in Europe for mitral and tricuspid valve repair. The PASCAL system provides a differentiated, minimally-invasive therapy to address the needs of patients with mitral or tricuspid regurgitation through leaflet approximation, while the Cardioband system enables clinicians to reduce the valve's annulus to restore a patient’s mitral or tricuspid valve to a more functional state and lower regurgitation.
The company’s two-platform mitral replacement strategy positions it for leadership in the mid-to-long term. SAPIEN M3 is based on the proven SAPIEN valve, paired with a novel docking system. EVOQUE Eos is the company’s next generation transcatheter replacement system, designed specifically for mitral patients. Both SAPIEN M3 and EVOQUE Eos are implanted with transfemoral delivery systems that are sub 30-French, which has benefits for femoral puncture and septal crossing, contributing to ease of use, and patient safety. For tricuspid valve replacement, its EVOQUE system is also sub 30-French, and available in three valve sizes to enable treatment in a wide range of patient anatomies.
Surgical Structural Heart
The company is pioneering more resilient surgical therapies that help patients and can improve the quality of their lives. Its latest innovation, the INSPIRIS RESILIA aortic valve, is built on its PERIMOUNT platform and offers RESILIA tissue and VFit technology. INSPIRIS is the leading aortic surgical valve in the world. The sale of the company’s surgical therapies in the United States also continue to gain traction with KONECT RESILIA, the first pre-assembled, aortic tissue valved conduit, for patients who require replacement of the valve, root, and ascending aorta. In 2021, it also received regulatory approval with reimbursement in Japan for its MITRIS RESILIA valve, a new mitral valve incorporating the company’s newest tissue technology. In addition to its replacement valves, it is the worldwide leader in surgical heart valve repair therapies. The company’s HARPOON Beating Heart Mitral Valve Repair System can help transform care for many patients with degenerative mitral regurgitation.
The company is a world leader in advanced hemodynamic monitoring systems used to measure a patient's heart function and fluid status in surgical and intensive care settings. Its complete hemodynamic portfolio helps clinicians make proactive clinical decisions that can improve patient outcomes. The portfolio includes the minimally invasive FloTrac and Acumen IQ sensors, the noninvasive ClearSight and Acumen IQ cuffs, and the ForeSight noninvasive tissue oximetry sensor. The company also supports clinical needs with its well-established Swan-Ganz line of pulmonary artery catheters and arterial pressure monitoring products. Compatible with its portfolio of sensors and catheters, the HemoSphere monitoring platform displays valuable physiological information in an easy to understand and actionable manner. The company’s first predictive algorithm, Acumen Hypotension Prediction Index software, alerts clinicians in advance of a patient developing dangerously low blood pressure and amplifies the clinical need for its Acumen IQ and HemoSphere monitoring solutions.
Sales and Marketing
The company’s distribution system consists of several direct sales forces and independent distributors.
The company relies extensively on its sales and field clinical specialist personnel who work with its customers in hospitals. Its customers include physicians, nurses, and other clinical personnel, but can also include decision makers, such as service line leaders, material managers, biomedical staff, hospital administrators and executives, purchasing managers, and ministries of health. Also, for the certain of the company’s product lines and where appropriate, its corporate sales team actively pursues approval of the company as a qualified supplier for hospital group purchasing organizations (GPOs) that negotiate contracts with the suppliers of medical products. Additionally, it has contracts with various United States and European national and regional buying groups, including healthcare systems and integrated delivery networks.
The United States: In the United States, the company sells substantially all of its products through its direct sales forces.
Outside of the United States: The company sells its products in approximately 100 countries. Its major international markets include Canada, China, France, Germany, Italy, Japan, Spain, and the United Kingdom. A majority of the sales and marketing approach outside of the United States is direct sales, although it varies depending on each country's size and state of development.
The company’s operations are frequently inspected by the many regulators that oversee medical device manufacturing, including the United States Food and Drug Administration (FDA), European Notified Bodies, and other regulatory entities. The medical technology industry is highly regulated and the company’s facilities and operations are designed to comply with all applicable quality systems standards, including the International Organization for Standardization (ISO) 13485.
The company owns or has rights to a substantial number of patents and has patent applications pending both in the United States and in foreign countries. Moreover, the company owns certain United States registered trademarks used in its business.
Government Regulation and Other Matters
The company’s products and facilities are subject to regulation by numerous government agencies, including the FDA, European Union Member States competent authorities, and the Japanese Pharmaceuticals and Medical Devices Agency, to confirm compliance with the various laws and regulations governing the development, testing, manufacturing, labeling, marketing, and distribution of its products.
The company is also subject to additional laws and regulations that govern its business operations, products, and technologies, including:
Federal, state, and foreign anti-kickback laws and regulations, which generally prohibit payments to anyone, including physicians as an inducement to purchase or recommend a product;
The Stark law, which prohibits physicians from referring Medicare or Medicaid patients to a provider that bills these programs for the provision of certain designated health services if the physician (or a member of the physician's immediate family) has a financial relationship with that provider;
Federal and state laws and regulations that protect the confidentiality of certain patient health information, including patient records, and restrict the use and disclosure of such information, in particular, the Health Insurance Portability and Accountability Act of 1996;
The Physician Payments Sunshine Act, which requires public disclosure of the financial relationships of the United States physicians and teaching hospitals with applicable manufacturers, including medical device, pharmaceutical, and biologics companies;
The False Claims Act, which prohibits the submission of false or otherwise improper claims for payment to a federally funded health care program, and health care fraud statutes that prohibit false statements and improper claims to any third-party payor; and
The United States Foreign Corrupt Practices Act, which can be used to prosecute the United States companies for arrangements with foreign government officials or other parties, or for not keeping accurate financial records or maintaining adequate internal controls to prevent and detect arrangements with foreign government officials or other parties.
The delivery of the company’s products is subject to regulation by the United States Department of Health and Human Services (HHS) and comparable state and foreign agencies responsible for reimbursement and regulation of health care items and services.
The company’s quarterly net sales are influenced by many factors, including new product introductions, acquisitions, regulatory approvals, patient and physician holiday schedules, and other factors. Net sales in the third quarter (year ended December 2021) are typically lower than other quarters of the year due to the seasonality of the United States and European markets, where summer vacation schedules normally result in fewer medical procedures.
In Transcatheter Aortic Valve Replacement, the company’s primary competitors include Medtronic PLC and Abbott Laboratories (Abbott). In Transcatheter Mitral and Tricuspid Therapies, its primary competitor is Abbott. In Surgical Structural Heart, the company’s primary competitors include Medtronic PLC, Abbott, and Artivion, Inc. In Critical Care, it competes primarily with a variety of companies in specific product lines, including ICU Medical, Inc.; PULSION Medical Systems SE, a subsidiary of Getinge AB; Cheetah Medical, Inc., a subsidiary of Baxter International; and LiDCO Group PLC, a subsidiary of Masimo Corporation.
Edwards Lifesciences Corporation was founded in 1958. The company was incorporated in Delaware in 1999.