Edwards Lifesciences Bets Big on Heart Valve Dominance Amid FTC Scrutiny

IRVINE, CA – December 04, 2025 – Edwards Lifesciences laid out an aggressive blueprint for sustained market leadership at its annual investor conference, projecting robust growth into 2026 and beyond. The structural heart giant reaffirmed its confident financial outlook, underpinned by a torrent of innovation across its valve replacement and repair portfolio. However, beneath the polished projections of double-digit growth lies a high-stakes regulatory battle with the Federal Trade Commission (FTC) that could shape the competitive landscape for the next generation of cardiac care.

At the conference, CEO Bernard Zovighian painted a picture of a company firing on all cylinders. “As we enter 2026, we are poised for sustainable growth and long-term value creation,” he stated, emphasizing the company's commitment to tackling unmet needs for millions of structural heart patients. This confidence is backed by hard numbers. Edwards reaffirmed its strong 2025 guidance and issued an ambitious 2026 forecast, projecting total sales of $6.4 to $6.8 billion, representing 8% to 10% constant currency growth, and adjusted earnings per share of $2.80 to $2.95. These figures, which slightly edge out a bullish Wall Street consensus that already carries a “Strong Buy” rating from many analysts, signal that the company sees clear skies ahead for its core franchises.

The Financial Engine of Innovation

A deeper dive into the guidance reveals a multi-pronged growth strategy. The company’s flagship Transcatheter Aortic Valve Replacement (TAVR) division, powered by the SAPIEN platform, is expected to grow a steady 6% to 8%, reaching up to $4.9 billion in sales. While TAVR remains the bedrock of Edwards’ revenue, the real explosive growth is projected in its Transcatheter Mitral and Tricuspid Therapies (TMTT) segment. With an eye-popping 35% to 45% growth forecast for 2026, TMTT is on a trajectory to become a major growth engine, with the company setting a bold target of $2 billion in annual sales by 2030.

This TMTT surge isn't just a projection; it's the result of a deliberate, multi-year investment in a differentiated portfolio. While competitor Abbott Laboratories has long held a strong position with its MitraClip device, Edwards is countering with a suite of solutions including the PASCAL repair system and the EVOQUE replacement system. This strategy of offering both repair and replacement options is a key differentiator, particularly in Europe, allowing for more personalized patient therapy.

The most anticipated milestone is the expected FDA approval of the SAPIEN M3 mitral valve in early 2026. Poised to be the world's first transcatheter mitral valve replacement system, its successful launch would represent a monumental step in treating mitral regurgitation and could significantly disrupt the current market dynamics, solidifying Edwards’ position as a leader in this complex and challenging field.

Expanding the Frontiers of Cardiac Care

Beyond bolstering its core franchises, Edwards is strategically pushing into new therapeutic frontiers, aiming to create new markets where few treatment options currently exist. Two areas stand out: Structural Heart Failure and, most notably, Transcatheter Aortic Valve Replacement for Aortic Regurgitation (TAVR-AR).

Aortic regurgitation (AR), a condition where the aortic valve fails to close properly, affects a significant and growing patient population, many of whom are too high-risk for open-heart surgery. Standard TAVR devices, designed for the calcified valves of aortic stenosis, are often unsuitable for AR. This represents a vast, untapped market, and Edwards has made it clear it intends to lead the charge.

This ambition is the driving force behind its proposed acquisition of JenaValve Technology, a company whose Trilogy system is on the cusp of becoming the first FDA-approved TAVR-AR therapy in the U.S. By acquiring JenaValve, Edwards would not just enter the TAVR-AR market; it would immediately command it. This move, combined with its recent acquisition of another TAVR-AR innovator, JC Medical, underscores a clear strategy to corner the market before it even fully materializes.

A Strategic Acquisition Under the Microscope

While Edwards' growth narrative is compelling, its path to dominating the TAVR-AR space faces a formidable obstacle: the U.S. Federal Trade Commission. In a move that sent ripples through the medtech industry, the FTC filed a lawsuit to block the JenaValve acquisition, arguing it would create a monopoly. The commission’s concern is that by acquiring the only two viable players with devices in late-stage U.S. trials—JenaValve and JC Medical—Edwards would extinguish competition, stifle innovation, and ultimately harm patients and health systems.

The FTC's challenge transforms this transaction from a standard strategic acquisition into a high-stakes legal and corporate drama. An administrative hearing is scheduled for early 2026, and the outcome will have profound implications. If Edwards prevails, it will gain unparalleled control over a nascent, multi-billion-dollar market. If the FTC succeeds in blocking the deal, the TAVR-AR landscape will remain a competitive field, pitting an independent JenaValve against Edwards’ own J-Valve device from its JC Medical acquisition.

Tellingly, Edwards has already factored dilution from the planned JenaValve acquisition into its 2026 earnings guidance, a sign of its determination to see the deal through. This calculated risk highlights the central tension in the company’s current strategy: balancing the aggressive pursuit of market dominance with the complexities of regulatory oversight. The company is simultaneously projecting confidence to investors while preparing for a legal battle that could redefine one of its most promising future growth drivers. As Edwards continues to push the boundaries of what’s possible in structural heart treatment, its biggest disruption in the near term may come not from a lab, but from a courtroom.