Edwards Lifesciences (EW): Leader of Cardiology Tech

Investing In Cardiology

When investors look at medicine-related stock, some might think of major health insurers, or hospital chains, or blue chip pharmaceutical companies like Eli Lilly (LLY -0.88%), for example. Others will look at innovative biotech startups, like Vertex , Regeneron (REGN +0.7%), or CRISPR Therapeutics (CRSP -0.96%).

This would ignore another medical sector that is both highly profitable and keeps hundreds of millions of people alive daily: medical devices.

In this category, none have been as important as cardiac medical devices, from artificial heart valves to pacemakers to various stents, saving lives by the tens of millions every year.

As the population ages, this is a sector poised for steady growth. And no company has been as instrumental in developing this field as Edwards Lifesciences.

A Pioneer In Cardiac Devices

Edwards Lifesciences’ roots date to 1958, when Miles “Lowell” Edwards set out to build the first artificial heart.

He invented the first medically proven and adopted artificial heart valve. To date, 1,500,000 patients have been treated with transcatheter therapies from the company.

The device proved remarkably durable, with some patients having used it for more than 48 years before needing a replacement.

Source: Edwards Lifesciences

From this early success, the company constantly pushed the limit of what could be repaired in the heart muscle, covering today aortic valve replacements, heart valves, valve repairs, and heart monitoring.

Source: Edwards Lifesciences

Edwards Lifesciences employs more than 16,000 people, owns more than 10,000 patents, and has a remarkable track record of 95% of Edwards’ technologies being category-leading.

Heart Surgery Device Market Outlook

The heart surgery device market is a small but important sub-section of cardiology. This is a $17.1B market, growing at 5.5% CAGR, expected to reach $24.9B by 2030.

Currently, Edwards controls around half of the cardiac surgery device market. Only two other companies have a significant presence in this market comparable to Edwards: Abbott (ABT -0.75%) and Medtronic (MDT -0.68%).

The major driver of growth in this segment is the aging of the population, with the portion of seniors (>65 years) in the USA constantly growing, expected to jump from 17% to more than 23% by 2050. In parallel, unhealthy diets and sedentary lifestyles also contribute to cardiac issues becoming more common.

Source: Statista

Edwards Lifesciences Product Portfolio

Each of Edwards’ products is expected to grow at 5% or more in the coming years, and could accelerate if new products are able to capture further market shares from its competitors.

Source: Edwards Lifesciences

Aortic Valves: Sapien

The core of the company is still, to this day, its artificial heart valves, with the “Sapien” product line-up being constantly improved since its first iterations in 2007.

Source: Edwards Lifesciences

This has been a best-in-class product with superior results in reducing heart disease-related deaths through many different markets and clinical studies. This includes a 99% rate of patients “alive and well” after 1 year, and 90% of patients after 5 years.

Source: Edwards Lifesciences

The latest version of Sapient, SAPIEN 3 Ultra RESILIA, is the most implanted valve in the US and Japan and is under launch in the EU.

The next version, Sapien X4, is soon to start its clinical trials, with patient enrollment already completed and tests ongoing.

https://www.youtube.com/watch?v=5jLfPlQBYuw

Early TAVR

Edwards is exploring the potential for “early transcatheter aortic valve replacement (TAVR) as a new market and a new way to save lives, with an ongoing clinical trial with 1578 asymptomatic patients.

The preliminary results indicate that early TAVR intervention could radically improve survival rates of patients, compared to the recommended clinical surveillance.

Source: Edwards Lifesciences

This seems to stem from the fact that patients in clinical surveillance for heart problems experienced rapid and unpredictable disease progression with a significant decline in quality of life.

This complex patient path is far from optimal, and delaying TAVR intervention by as much as 5 months.

Instead, the proposed therapeutic path proposed by Edwards in the early TAVR study would reduce this process to just 90 days or below.

Source: Edwards Lifesciences

Such a change in medical procedure would actually save money as well, as urgent care has tens of thousands of costs to patients and the healthcare system at large. Instead, early surgery could reduce unplanned hospitalization by half.

Source: Edwards Lifesciences

This discovery could radically change the medical guidelines in the USA and globally, with the reevaluation process starting in the USA in 2025 and the rest of the world in 2026, and potential implementation of these changes eventually starting by 2027-2028.

Transcatheter Mitral and Tricuspid Therapies (TMTT)

TMTT addresses cardiac symptoms using catheters, rather than open-heart surgery.

These therapies are becoming increasingly important as they offer alternative treatment options for patients, particularly those who are high-risk for surgery.

Source: Edwards Lifesciences

Edwards offers several other artificial heart valves besides the aortic valve, addressing TMTT.

Notably, the EVOQUE valve is larger, increasing the population of patients that can be treated with it, and fully removing tricuspid regurgitation; and Mitral transcatheter therapy using the PASCAL valve is already deployed, and should see the arrival of an easier-to-use new version in 2026.

Source: Edwards Lifesciences

Surgical

Surgical aortic valves and other surgical products are designed to avoid open-heart surgery if possible.

Source: Edwards Lifesciences

Its RESILIA tissue is transformed to resist calcification differently. It offers enhanced anti-calcification technology that will potentially allow the valve to last longer than conventional bioprosthetic valves.

This is a quickly growing segment for the company, following the market growth at 10% CAGR, usually affecting younger patients (mean age of 61 years old).

It will also grow quickly thanks to progress made in healthcare in developing countries, where surgical revenue grows twice as quickly as in developed countries, despite their average older demographics.

Implantable Heart Failure Management (IHFM)

These devices are there to help reduce the impact of heart failure, an affliction with a 75% mortality rate after 5 years and costing $40B in care in the US alone, with 1.2 million patients in the country.

Edwards sells the Cordella Sensor and Heart Failure System, which helps monitor patients with heart failure at home. It achieves a 49% reduction in mortality rates and a significant improvement in quality of life for the patients.

Source: Edwards Lifesciences

Critical Care

Edwards used to have a critical care business, which it recently sold to  Becton, Dickinson and Company (BDX -0.2%) for $4.2B. It included notably the HemoSphere, a tool to monitor pressure, flow, and tissue oximetry during cardiac events.

The money from the sale will be used to fund strategic initiatives, including the previously announced acquisitions and share repurchases.

Edwards’ Future Growth

Acquisitions

Despite the overall market growing at 5-6%, Edwards has been able to consistently grow its sales at 8-10% in the past decades.

One reason is that the company has been a serial acquirer, acquiring small competitors and companies with complementary technologies, for example, Valtech Cardio and Harpoon Medical in 2017, CAS Medical Systems in 2018, and Kephalios, Innovalve Bio Medical, and Endotronix in 2024.

This string of acquisitions might however, become harder to replicate in the future., For example, the FTC (U.S. Federal Trade Commission) has recently refused the proposition made in 2024 by Edwards to acquire JenaValve Technology.

JenaValve product mostly treats Aortic Regurgitation (AR), a deadly disease that goes largely untreated, despite a 24% mortality rate after 1 year if left untreated. It has no commercial alternatives to surgery so far.

Edwards aimed to make it its new flagship product line, similar to TAVR surgeries, making the criticism of the FTC a little puzzling.

Edwards disagrees with the FTC’s decision and believes it will limit the availability of an important treatment option for patients suffering from aortic regurgitation (AR).

The company further believes the acquisition of JenaValve will accelerate the availability, adoption, and continued innovation of a life-saving treatment for patients suffering from AR.

While it might be true that Edwards has no intent to limit the availability of heart surgery devices, this reveals that the FTC is starting to get concerned over monopoly risks in the sector.

So overall, investors should expect Edwards’ future growth to come more from internal efforts, and less from acquisitions, especially if future acquisitions are vetoed by regulators.

Research & Development

Edwards has been spending its $1.1B yearly R&D budget on expanding its offering and improving its understanding of heart diseases, with 75% of the total budget. The rest is dedicated to the support of existing therapies, either improving their implementation or refining the understanding of the individual outcome for each patient.

Source: Edwards Lifesciences

So far, Edwards’ R&D efforts are mostly focused on improving its existing product line, and supporting the creation of medical data, helping change medical procedures toward better care and earlier surgical interventions.

This is not to say that the company is not working on important innovations; it instead reflects that cardiology is a field that is very cautious in its adoption of new technologies, as the seriousness of the conditions encourages surgeons to stick to what they know works.

Edwards Lifesciences Financial Performance

Revenues & Margins

The company is aiming for $5.6-6B of revenues in 2024, with sales growing at 8-10%. This represents remarkably higher sales than a decade ago, almost doubling the company’s revenues.

Source: Edwards Lifesciences

Gross margins are staying high, at 78-79%, and operating margins are at 27-28%.

Edwards’ Capital Allocation

Regarding capital expenditure, the company has been constantly spending $250M yearly since 2023. It is mostly focused on “manufacturing resiliency”, reducing its exposure to supply chain risks and tariffs in a context of escalating trade wars.

Source: Edwards Lifesciences

Edwards Lifesciences is a company committed to strong returns to its shareholders, notably through a program of share repurchases ranging from $510M-$1.7B in the past few years. It is, however, not distributing dividends.

Source: Edwards Lifesciences

Competitive Position

In the very long-term, 10 or 20 years in the future, Edwards Lifesciences’ products might become less popular due to alternatives like direct regeneration with stem cells or lab-grown biological valves.

So while the long-term potential for alternatives may exist one day, the company has a long period ahead where its products will be in high demand due to population aging, and dominate their respective market niche.

The competition from other medical device companies should not be ignored, but should also not be overstated. Edwards has, if anything, increased its dominance over the cardiac valve market in the past 1-2 decades, thanks to a commitment to manufacturing excellence and a razor-sharp focus in its R&D efforts, something that more generalist pharmaceutical companies like Medtronic and Abbott have struggled to replicate.

Conclusion

Edwards Lifesciences is a company that was built over the first artificial cardiac valve, and remains the dominant actor in this segment.

As a life-saving device with the highest possible requirement in terms of expertise and manufacturing quality, this position illustrates Edwards’ excellence and is recognized by cardiac surgeons.

This gives the company a very powerful moat not only from its technical abilities, but also the trust of its brand among the very experts that decide what cardiac valves to install on their patients.

Thanks to continuous innovation, the company should stay a steady investment, compounding year after year, building from its current position toward increasing survival rates thanks to earlier aortic surgeries and even more reliable artificial valves.

Latest Edwards Lifesciences (EW) Stock News and Developments