Edwards Lifesciences (EW) Q3 2025: TMTT Accelerates 53%, Expanding Structural Heart Growth Pipeline

October 30, 2025 | By EarningsIQ Research

Edwards Lifesciences delivered double-digit sales growth in Q3, propelled by rapid expansion in transcatheter mitral and tricuspid therapies (TMTT) and sustained momentum in its core TAVR franchise. Clinical evidence and new guidelines are fueling broader adoption, while the company’s disciplined investment in innovation and operational scale positions it for multi-year growth. An upcoming CFO transition and key regulatory milestones add both opportunity and complexity to the forward outlook.

Summary

• TMTT Outpaces Core Franchise: Mitral and tricuspid therapies drove the largest incremental growth, reinforcing pipeline depth.
• Clinical Evidence Shifts Market: New long-term data and updated guidelines are accelerating adoption and expanding patient eligibility.
• 2026 Growth Visibility Builds: Raised guidance and strong balance sheet support confidence, as leadership prepares for succession and new product launches.

Performance Analysis

Edwards Lifesciences posted 12.6% constant currency sales growth in Q3, reaching $1.55 billion, with broad-based strength across its structural heart portfolio. The Transcatheter Aortic Valve Replacement (TAVR, minimally invasive aortic valve replacement) business contributed $1.15 billion, up 10.6% year over year, while the TMTT (Transcatheter Mitral and Tricuspid Therapies) segment surged 53% to $144 million, marking its highest growth rate and increasing its share of company-wide expansion. Surgical therapies also performed well, growing 5.6% to $258 million, anchored by the Resilia tissue platform.

Profitability remained robust, with adjusted gross margin at 77.9%, though slightly below the prior year due to FX and higher operational costs. Operating margin benefited from both stronger sales and deferred spending, but management reiterated expectations for lower Q4 margins as investments ramp up. A strong balance sheet with $3 billion in cash and an expanded $2 billion buyback authorization provides capital allocation flexibility.

• TMTT Growth Engine: TMTT’s 53% growth reflects rising procedure volumes and new product launches, positioning it as a key future lever.
• Evidence-Driven Adoption: Multiple late-breaking trials and updated guidelines are catalyzing earlier intervention and wider patient pools.
• Operational Leverage: Top-line outperformance and disciplined R&D allocation are supporting margin stability, even as investment increases.

Management raised full-year sales and EPS guidance, reflecting confidence in sustained growth and expanding addressable markets.

Executive Commentary

Strategic Positioning

1. TMTT as a Multi-Year Growth Catalyst

TMTT’s 53% YoY growth underscores its emergence as a core growth driver for Edwards. The segment’s expansion is fueled by differentiated platforms—Pascal (repair), Evoque (replacement), and Sapien M3 (transseptal mitral valve)—that address large unmet needs in mitral and tricuspid disease. Management projects TMTT to reach $2 billion by 2030, with recent clinical evidence and guideline changes accelerating adoption and referrals. The company’s “toolbox” approach, offering both repair and replacement, is producing compounding value across the care continuum.

2. TAVR Franchise Stability and Expansion

TAVR remains Edwards’ anchor, with mid- to high-single-digit growth expected for the foreseeable future. Recent seven- and ten-year clinical data confirmed long-term durability and safety of the Sapien platform, reinforcing physician and patient confidence. Updated global guidelines and potential new U.S. coverage decisions are expanding eligibility, while exit of a competitor in Europe contributed a modest tailwind. Management emphasized that Q3’s above-trend growth benefited from reduced summer seasonality and should not be extrapolated as the new baseline.

3. Clinical Evidence and Guidelines as Market Catalysts

Edwards’ strategy centers on leadership in evidence generation, with pivotal trials and registry data showcased at major conferences. New data sets, including the PARTNER III and TRICEN studies, are shifting clinical practice toward earlier intervention and expanding the market for both TAVR and TMTT. The company’s ability to translate evidence into commercial adoption is a core competitive advantage.

4. Operational Discipline and R&D Prioritization

Disciplined investment in R&D (18.1% of sales in Q3) is supporting pipeline innovation while allowing operating leverage. Management reiterated that top-line growth will outpace R&D spending growth, with a focus on prioritizing high-impact programs. Operational initiatives—such as cath lab efficiency, AI-driven patient identification, and direct-to-patient education—are supporting both volume and quality outcomes.

5. Leadership Succession and Capital Allocation

CFO Scott Ullum’s planned transition by mid-2026 introduces a near-term leadership change, though the company has a succession plan in place and Ullum will remain as a strategic advisor. The expanded buyback program and strong liquidity signal ongoing commitment to shareholder returns and strategic flexibility.

Key Considerations

This quarter’s results highlight Edwards’ ability to balance robust innovation with operational execution, as it navigates both established and emerging markets in structural heart therapies.

Key Considerations:

• TMTT Inflection Point: Rapid growth and expanding indications suggest TMTT will become a larger share of total revenue, increasing exposure to new therapy adoption curves.
• Guideline and Policy Tailwinds: Updated U.S. and European guidelines, along with potential new coverage decisions, could accelerate both TAVR and TMTT procedure growth.
• R&D Leverage: Continued prioritization of R&D spending is essential to maintain innovation leadership without overextending cost structure.
• CFO Transition: Leadership change introduces some execution risk, though succession planning and advisory continuity should mitigate disruption.
• International Expansion: Growth outside the U.S. is increasingly important, particularly as adoption in underpenetrated regions accelerates.

Risks

Execution risk remains around scaling TMTT, particularly as new therapies move from controlled launches to broader commercialization. Regulatory and reimbursement uncertainties—especially in the U.S.—could affect future adoption rates. Leadership transition in the CFO role adds a layer of near-term uncertainty, while FX volatility and ongoing litigation (as reflected in GAAP results) are additional watchpoints. Competitive dynamics, particularly in Europe and Japan, could pressure pricing or share.

Forward Outlook

For Q4, Edwards guided to:

• Total company sales of $1.51 to $1.59 billion
• Adjusted EPS of $0.58 to $0.64

For full-year 2025, management raised guidance:

• Sales growth at the high end of 9% to 10% range
• EPS range of $2.56 to $2.62

Management highlighted several factors that support the outlook:

• Ongoing evidence generation and guideline updates expanding addressable patient pools
• Operational investments deferred to Q4, with margin discipline expected to continue in 2026

Takeaways

Edwards Lifesciences is entering a new phase of growth, with TMTT providing an incremental engine alongside a resilient TAVR base. The company’s evidence-driven approach is creating lasting competitive differentiation, while operational discipline and balance sheet strength support strategic flexibility.

• Clinical Data Drives Adoption: Landmark trial results and new guidelines are accelerating physician confidence and expanding patient eligibility, particularly in TMTT.
• Pipeline and Platform Depth: Continued innovation in both repair and replacement therapies positions Edwards for sustainable, multi-segment growth.
• Execution and Leadership Transitions: Smooth CFO succession and disciplined capital allocation will be key to maintaining momentum through product launches and market expansions.

Conclusion

Edwards Lifesciences delivered a quarter that reinforced its leadership in structural heart, with TMTT’s breakout growth and robust TAVR performance underpinned by compelling clinical evidence. As the company navigates leadership transition and prepares for new product launches, its disciplined approach and innovation pipeline provide strong support for continued multi-year growth.

Industry Read-Through

Edwards’ results and commentary highlight several industry-wide shifts: The rapid adoption of transcatheter mitral and tricuspid therapies signals that minimally invasive interventions are moving beyond aortic disease, creating new multi-billion-dollar markets. Clinical evidence and updated guidelines are proving to be powerful levers for accelerating adoption across structural heart. Competitors in medtech with strong evidence-generation capabilities and diversified portfolios are best positioned to capture share as regulatory and reimbursement barriers fall. The growing importance of operational efficiency, AI-enabled patient identification, and direct-to-patient education reflects a broader trend toward integrated, data-driven care delivery in cardiovascular medicine.

EW Healthcare Medical Devices Structural Heart TAVR TMTT Clinical Evidence R&D