stockrowWhat it does
Edwards Lifesciences makes medical devices for structural heart disease, with a focus on repairing or replacing heart valves. A faulty valve can disrupt the heart’s function or blood flow. Edwards sells therapies used by cardiac surgeons and interventional cardiologists to treat patients with these conditions.
Some Edwards products are used in conventional surgery. A surgeon may replace a faulty valve with a tissue valve or repair it with an annuloplasty ring. Other products are delivered through a catheter, allowing a physician to implant a valve or repair system without traditional open-heart surgery and while the heart continues to beat.
The company groups its products into transcatheter aortic valve replacement, or TAVR; transcatheter mitral and tricuspid therapies, or TMTT; and Surgical Structural Heart. Its SAPIEN valves treat aortic valve disease. Its PASCAL, EVOQUE and SAPIEN M3 systems repair or replace mitral and tricuspid valves, while its surgical portfolio includes tissue valves and related devices.
Edwards also works with clinicians on research, training and support during procedures. It sells through its own sales forces and independent distributors to customers that include hospitals and health systems. The company was founded in 1956 and is headquartered in Irvine, California. Bernard Zovighian is its chief executive officer.
How it makes money
Edwards earns revenue by selling devices used to repair and replace heart valves. Its products are used in procedures performed by physicians, and the company supports their use through sales personnel and clinical specialists. It also seeks supplier approval from hospital purchasing organizations and contracts with national and regional buying groups.
Net sales were $6.1 billion in 2025; third-quarter 2026 sales were $1.72 billion.
TAVR is the largest product group. Its SAPIEN family of valves is delivered through a catheter to treat aortic stenosis, a narrowing of the aortic valve. Higher sales of the SAPIEN 3 Ultra RESILIA valve in the United States and Europe helped drive the group’s sales increase that year. Edwards said its global TAVR average selling prices were stable in the third quarter of 2026.
TMTT includes repair and replacement devices for the mitral and tricuspid valves. PASCAL repairs valves, EVOQUE replaces the tricuspid valve, and SAPIEN M3 replaces the mitral valve. Sales growth in 2025 was driven primarily by higher PASCAL and EVOQUE sales in the United States and Europe.
Surgical Structural Heart sells tissue valves and related products, including the INSPIRIS RESILIA aortic valve, MITRIS RESILIA mitral valve and KONECT RESILIA aortic valved conduit. Surgical sales increased in 2025 primarily because of higher sales of those products. Edwards’ sales are influenced by procedure volumes, product introductions, regulatory approvals and seasonal changes in physician and patient schedules.
| Product or service | Revenue, FY2025 | Share | Change on the year |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement | $4.5 billion | 74.0% | 9.29% |
| Surgical Structural Heart | $1.0 billion | 17.0% | 4.89% |
| Transcatheter Mitral and Tricuspid Therapies | $550.6 million | 9.07% | 56.4% |
Customers and how it sells
Edwards’ customers include physicians, nurses and clinical personnel as well as hospital administrators, purchasing managers, biomedical staff and ministries of health. Its corporate sales team also seeks to qualify Edwards as a supplier to hospital group purchasing organizations, which negotiate contracts with medical-product suppliers. The company has contracts with buying groups and integrated healthcare networks in the United States and Europe.
Edwards uses several direct sales forces and independent distributors. It sells substantially all of its products directly in the United States. Outside the United States, its approach is mostly direct sales and consignment arrangements, although it varies by country. Edwards sells products in approximately 100 countries, and the availability of reimbursement to hospitals and other providers influences where it chooses to market them.
No single customer accounted for 10% or more of net sales in 2025. The United States generated $3.5 billion in FY2025 revenue, or 58.4% of the total; Europe generated $1.5 billion, or 25.0%. Japan and the rest of the world are the company’s other reporting regions.
Field clinical specialists routinely attend procedures where Edwards products are used and advise customers on using the therapies. Edwards also provides educational events and training for physician, nursing, hospital leadership and other clinical customers.
| Segment | Revenue, FY2025 | Share | Change on the year |
|---|---|---|---|
| United States | $3.5 billion | 58.4% | 10.5% |
| Europe | $1.5 billion | 25.0% | 14.8% |
| Rest of World | $652.3 million | 10.8% | 14.0% |
| Japan | $354.7 million | 5.85% | 4.38% |
Suppliers and costs
Edwards manufactures its TAVR, TMTT and surgical products primarily in the United States, Singapore, Costa Rica and Ireland. Most replacement heart valves use natural animal tissue alongside fabricated materials. The company obtains bovine tissue for its pericardial tissue valves from sources in the United States and Australia. Other materials used across its products include resins, chemicals, electronics and metals.
Edwards buys some materials and components from external suppliers. Certain supplies come from single sources because alternatives are unavailable or because of regulatory constraints. The company generally identifies and approves alternatives for critical materials, but does not typically seek immediate regulatory qualification of those sources because of the time and expense involved.
Research and development, clinical studies, sales and field support are part of the cost structure. Edwards invested 18% of its net sales in research and development in 2025. Its 2025 gross profit rose with sales, while gross profit as a percentage of sales declined primarily because of higher operational expenses. Selling, general and administrative expenses increased in part because of field personnel and marketing costs. Edwards also incurred expenses related to legal settlements, contingencies and litigation.
- Revenue$6.1B
- Cost of revenue−$1.3B
- Research and development−$1.1B
- Selling, general and administrative−$2.1B
- Other operating costs−$304.8M
- Operating income$1.3B
Competitive position
Edwards competes with medical-device companies and with other technologies used to treat the same patients. Medtronic and Abbott are its primary competitors in TAVR and surgical therapies; Abbott is its primary competitor in TMTT. Edwards said the benefit from Boston Scientific’s exit in Europe and other markets outside the United States had fully annualized. It also said its U.S. TAVR competitive position was stable sequentially and increased modestly year over year in the third quarter of 2026.
Edwards’ competitive strategy includes product development, clinical studies and support for customers. It owns or has rights to patents and also relies on trade secrets, know-how, licensing and continuing innovation. Its field specialists work with hospital customers and attend procedures. The company develops clinical evidence for regulatory submissions and for payers, clinicians and healthcare systems.
Our reading: Clinical evidence and regulatory approvals are meaningful sources of differentiation because they support both permission to sell and adoption, although competitors can develop their own evidence and therapies. Our reading: Physician training and procedure support reinforce customer relationships, but hospitals and purchasing groups also weigh cost and clinical outcomes. Our reading: Patents and know-how provide protection, but that protection is contestable: Edwards has used litigation to enforce intellectual property, and its patents may be challenged.
| Competitor | Where they compete | Threat (our reading) |
|---|---|---|
| Medtronic plc | TAVR and surgical heart therapies | High |
| Abbott Laboratories | TAVR, mitral and tricuspid, and surgical therapies | High |
| Boston Scientific Corporation | Former TAVR competitor in Europe and other non-U.S. markets | Low |
Growth opportunities
Edwards is developing therapies and clinical evidence for aortic, mitral and tricuspid disease and for structural heart failure. Its research includes new TAVR products intended to improve and streamline procedures, as well as mitral and tricuspid technologies for valve repair and replacement. The company also develops surgical products for patients treated through surgery, including those undergoing complex combined procedures.
Edwards said the updated U.S. TAVR coverage policy expands coverage to asymptomatic patients and provides a pathway for coverage of future approved indications. The company has received U.S. approval for SAPIEN 3 in severe aortic stenosis patients without symptoms. It does not yet have a TAVR indication for moderate aortic stenosis. Edwards believes the moderate-disease opportunity is at least as large as the severe-disease opportunity, based on evidence from its PROGRESS trial and the ACTIVATE study.
In TMTT, Edwards said its full portfolio of mitral and tricuspid repair and replacement technologies is available in the United States following approval of PASCAL Precision for tricuspid regurgitation. It has also introduced SAPIEN M3 with RESILIA in Europe. The company targets $2 billion in TMTT revenue in 2030.
For 2026, Edwards expects total sales growth of approximately 11.5%. It targets approximately 10% average annual sales growth over the long term and expects growth in TAVR to be driven mainly by procedure volume rather than share gains.
- $5.2BFY2021
- $4.5BFY2022
- $5.0BFY2023
- $5.4BFY2024
- $6.1BFY2025
Structural risks
- Innovation and competition: Failure to develop differentiated products on time and market them effectively could materially affect Edwards’ prospects. New technologies or other therapies could make its products obsolete or uneconomical.
- Regulation and reimbursement: Device approvals can be lengthy, costly and uncertain. Changes in coverage or reimbursement could reduce demand or pricing flexibility, while larger purchasing groups can affect product pricing.
- Supply and manufacturing: Some materials come from single sources. Supplier financial problems, decisions to stop supplying medical-device companies, material restrictions, embargoes or trade measures can cause delays, shortages or higher prices.
- Product safety: It was reported on 16 October 2026 that a balloon-burst-related recall of the SAPIEN 3 Ultra delivery system covered 2,579 units. It was also reported that Edwards had recorded one death and one serious injury associated with the issue as of 5 October.
- Intellectual property: Edwards’ competitive position depends in part on patents and trade secrets. Its patents may be challenged and held invalid, and litigation has been necessary to enforce some rights.
- International operations: Currency fluctuations, tariffs, import and export requirements, and other trade measures can affect results. Edwards also faces regulations in the countries where it manufactures and sells devices.
Bottom line
Our reading
Edwards is a procedure-driven heart-device business whose revenue remains concentrated in aortic valve replacement, while mitral and tricuspid therapies offer another avenue for growth. Our reading is that clinical evidence, regulatory approvals and physician support help establish its position, but continued adoption depends on reimbursement, product safety and competition. Its international manufacturing and single-source supplies also create operating exposures.