Edwards Highlights PROGRESS Heterogeneity, Signals Modest Near-Term TAVR Impact in Q2 2026

Why Edwards highlighted PROGRESS heterogeneity, and how to frame its (potentially positive) impact vs. asymptomatic indications

1) Why highlight “heterogeneity” in PROGRESS?

Edwards highlighted heterogeneity because PROGRESS is the first randomized trial specifically in moderate aortic stenosis (AS), and management stated that the heterogeneous nature of this population is “not well understood,” so explaining baseline characteristics is essential for interpreting what the trial will ultimately mean. ¹²

More specifically, management’s stated reasons include:

• To improve physician understanding of trial design and patient mix. Edwards split the PROGRESS narrative into (i) baseline characteristics and (ii) the full TCT results because learning from earlier TAVR programs suggested that a short presentation makes it difficult for physicians to understand design, rationale, baseline characteristics, and results together. ¹
• To demonstrate that moderate AS patients are clinically complex and can be similar to severe AS in key baseline characteristics. Edwards said that “moderate is at least as big as severe,” that the population is “very diverse” and “very complex,” and that severe vs. moderate patients show no difference in age in their analysis. ¹
• To clarify what “at-risk feature” means inside moderate AS. Management emphasized that PROGRESS enrolls moderate AS patients with at least one at-risk feature (not “heart failure patients”), and that baseline characteristics show these patients are not “clinically benign.” ²³
• To quantify representativeness of the at-risk subgroup. Edwards stated that the at-risk-feature subgroup is suggested by literature to represent about 50% of the total moderate population, and therefore remains a “still…large population.” ²
• To avoid misinterpretation by comparing to other moderate-AS evidence. They explicitly contrasted PROGRESS with UNLOAD (a heart failure trial where patients happened to have moderate AS), arguing the populations differ materially; PROGRESS is moderate AS with at-risk features and surveillance design, which affects how results should be interpreted. ³

Bottom line: the heterogeneity emphasis is less about changing the biology of the disease and more about calibrating expectations—so that clinicians/investors understand which moderate AS patients are actually being studied and how they differ from “plain” moderate AS or from prior studies with different patient selection. ¹²³

---

2) If PROGRESS is positive, how would that impact the TAVR business relative to asymptomatic indications?

A) Timing: management expects minimal near-term impact (2026)

Even in the Q&A framing, Edwards guided to minimal impact in 2026, with long-term TAVR guidance designed to “accommodate” such scenario changes. ⁴

So, relative to asymptomatic indications (which already have regulatory and coverage momentum in some markets), PROGRESS would be best framed as a next incremental step that may matter more in the longer run than immediately in 2026. ⁴

B) Framing: PROGRESS as “new indication” requiring change management—like asymptomatic

Management said the way to think about PROGRESS (if positive) is similar to asymptomatic—both are described as new indications that don’t have a predicate in the sense that surveillance is the existing guideline recommendation, not immediate procedural intervention. ⁵

They highlighted the practical commercial implication: because current guidance is surveillance-based, adoption depends on change management, education, and human behavior shift—not just clinical proof. ⁵

They also explicitly analogized PROGRESS to the asymptomatic patient population: “we need to think about this patient population in a very similar way as the asymptomatic patient population.” ⁵

Implication: If PROGRESS is positive, the business impact should be modeled as an adoption curve—where clinical results unlock guideline/coverage discussions, and then centers and heart teams expand screening and referrals. ⁵

C) Where PROGRESS could be more “complex” than asymptomatic

Based on Edwards’ own heterogeneity discussion, PROGRESS involves a broader moderate AS subgroup with at-risk features that is described as:

• moderate AS patients with symptoms and at-risk features in trial enrollment (as “intended”), yet
• with healthy left ventricular function and not heart failure as the primary clinical context. ³

This mix suggests adoption may hinge on how confidently clinicians can identify “at-risk” moderate AS patients outside trial settings—potentially more nuanced than asymptomatic cohorts that are already becoming a known category through evidence generation and existing practice patterns. ²³

D) Commercial “apples-to-apples” comparison: both are guidance-driven market expansion catalysts, but adoption mechanics may differ

Edwards’ baseline setup implies that PROGRESS could expand the eligible TAVR population within moderate AS by moving part of it from surveillance to intervention earlier than guidelines would otherwise recommend. ²⁶

But management also emphasized that these are new indications and therefore adoption will require a similar rollout to asymptomatic, including learning and education by clinicians. ⁵

So the clean relative framing is:

• Asymptomatic indications: already part of a longer evidence and coverage evolution; impact is tied to ongoing policy/coverage adoption and center behavior changes. ⁵⁷
• PROGRESS (if positive): another “new indication” that likely follows the same category mechanics (surveillance → intervention), but the heterogeneity and at-risk-feature identification requirements could make the early adoption pathway more variable. ¹²⁵³

E) Expected market growth contribution: Edwards explicitly positions TAVR growth guidance to “accommodate” these scenarios

Management stated: practice moves slowly and they expect minimal impact in 2026; the long-term guidance for TAVR is mid- to high single digits designed to accommodate scenarios like PROGRESS. ⁴

Thus, relative to asymptomatic, the “frame” is not that PROGRESS will instantly outperform—it’s that PROGRESS would be an additional catalyst layered into the same longer-term TAVR growth model, with value potentially scaling as adoption and policy discussions progress. ⁴⁵

---

Summary answer

• Edwards highlighted PROGRESS heterogeneity because PROGRESS is the first randomized moderate AS trial, and physicians/investors need a deep understanding of who is enrolled (moderate AS with at-risk features), how diverse/complex the baseline characteristics are, and how this differs from other moderate-AS evidence (e.g., UNLOAD). ¹²³
• If PROGRESS is positive, management would frame its impact on the TAVR business as similar in category mechanics to asymptomatic—a new indication requiring change management and education because current guidelines recommend surveillance rather than intervention. ⁵
• They also guided that near-term (2026) impact should be minimal, with long-term TAVR growth guidance already structured to accommodate such scenarios. ⁴