[EW] Edwards Lifesciences: TAVR Growth Test as Share Gains Lap in Q3 2026

Edwards Lifesciences makes implantable devices for structural heart disease, and its largest product is the SAPIEN valve used in transcatheter aortic valve replacement (TAVR)[1]. According to Drillr's earnings calendar, the company reports Q3 2026 (three months ended September 30, 2026) results on 2026-11-04[2], and Edwards Lifesciences' TAVR growth is the central question. In the latest disclosed quarter, Q2 2026, total sales rose 13.6% to $1.741 billion (12.5% in constant currency), TAVR sales were $1.258 billion with 10.5% constant-currency growth, and adjusted EPS was $0.78; in July management guided third-quarter sales of $1.63 billion to $1.71 billion and adjusted EPS of $0.71 to $0.77, and raised full-year constant-currency sales growth guidance to 10% to 11%[3]. The consensus of 16 analysts compiled by Drillr calls for third-quarter revenue of $1.676 billion and EPS of $0.737, with full-year revenue of $6.770 billion[4].

Three things matter most in this report. The first is TAVR growth: the share Edwards gained when a competitor left Europe in Q2 2025 enters the prior-year base from the third quarter, and management said underlying third-quarter growth would be "artificially low" because Q3 2025 was unusually strong[5], so the gap between U.S. and European growth will show whether any slowdown reflects the comparison or demand. The second is the mitral and tricuspid business (TMTT): it posted $198.6 million in second-quarter sales, up 47.7%, while full-year guidance of $760 million to $780 million implies roughly $193 million to $203 million per quarter in the second half[3], so holding that level through the summer slowdown decides whether the guidance is credible. The third is margin: the first-half adjusted operating margin reached 30.7%[6], yet the company kept full-year guidance at the high end of 28% to 29% with R&D at about 17% of sales[3], which requires spending to rise and margin to fall to about 27% in the second half; the third quarter will show whether that decline is planned investment or spending that has been pushed out.

Company Background and Business Structure

Edwards now focuses only on implantable structural heart devices, organized into three product groups: TAVR, transcatheter mitral and tricuspid therapies (TMTT) and surgical structural heart valves[1]. The company sold its Critical Care business on September 3, 2024, and on December 18, 2025 sold a non-core business that was not focused on implantable structural heart innovation; both are reported as discontinued operations[1]. Its planned acquisition of JenaValve, signed in July 2024, was challenged by the U.S. Federal Trade Commission (FTC), the U.S. District Court for the District of Columbia granted an injunction on January 9, 2026, and the two companies terminated the merger agreement on January 14[7]. In February 2026 Edwards bought valve company Autus for $128.9 million plus up to $132.5 million in contingent consideration, and in May it amended agreements with a medical device company so that this previously unconsolidated variable interest entity is now consolidated[8].

TAVR dominates Edwards' revenue, accounting for $4.488 billion, or 74%, of 2025 continuing-operations sales of $6.068 billion[1]. TMTT contributed $550.6 million, or 9%, after growing 56.4%, while surgical valves contributed $1.029 billion, or 17%, after growing 4.9%[1]. U.S. customers generated 58% of sales, and no single customer accounted for 10% or more of sales[9]. By region in Q2 2026, U.S. sales were $1.004 billion, Europe $439.6 million, Japan $96.4 million and the rest of the world $201.5 million[3].

Edwards depends heavily on its own people and a few sites for selling and manufacturing. In the United States it sells substantially all products through direct sales forces, while outside the U.S. it uses both direct sales forces and independent distributors; field clinical specialists attend procedures to guide physicians, and the sales team seeks qualified-supplier status with hospital group purchasing organizations (GPOs)[9]. Whether Edwards enters a market depends on whether national health systems reimburse hospitals adequately; manufacturing is concentrated in the United States, Singapore, Costa Rica and Ireland, the bovine tissue for its pericardial valves comes only from the U.S. and Australia, some supplies are single-sourced, and the company had about 16,000 employees at the end of 2025[9].

Financial History and Current Position

In 2025 Edwards grew revenue by double digits, but litigation-related costs pulled operating income lower. Continuing-operations sales were $6.068 billion, up 11.5% from $5.440 billion in 2024[1]. Gross profit was $4.733 billion for a 78.0% gross margin; SG&A was $2.085 billion, R&D $1.079 billion and intellectual property agreement and certain litigation expenses $325.4 million, leaving operating income of $1.264 billion, below $1.379 billion in 2024, and net income attributable to Edwards of $1.074 billion[10].

Cash flow in 2025 was much stronger than in the prior year, and the balance sheet held ample cash. Operating cash flow was $1.595 billion, far above $542.3 million in 2024, with $395.1 million coming from higher accounts payable and accrued liabilities; capital expenditures were $260.2 million, and the company planned about $280 million of capital spending in 2026[10]. At the end of 2025, cash, cash equivalents and short-term investments were about $3.7 billion in the U.S. and $516.1 million abroad, $1.5 billion of cash was repatriated during the year, and the company also had a $750 million multi-currency revolving credit facility maturing in July 2027[7].

Revenue grew by double digits in both of the first two quarters of 2026, but one-time items depressed GAAP earnings. First-quarter sales rose 16.7% to $1.649 billion (12.7% in constant currency), TAVR sales were $1.197 billion, adjusted EPS was $0.78, and the company completed a $500 million accelerated share repurchase[11]. Second-quarter sales rose 13.6% to $1.741 billion (12.5% in constant currency), with TAVR at $1.258 billion, TMTT at $198.6 million and surgical at $284.1 million, an adjusted gross margin of 77.6%, an adjusted operating margin of 30.0% and adjusted EPS of $0.78[3]. Second-quarter GAAP EPS was only $0.42, mainly because California legislation enacted on June 29 limited the use of R&D tax credit carryovers, leading Edwards to record a $188.2 million allowance against certain deferred tax assets, plus a $40.0 million impairment on an investment in a variable interest entity[6].

First-half cash flow continued to fund buybacks, but the cash balance fell well below its year-start level. The first-half adjusted operating margin was 30.7%, and GAAP operating income was $990.8 million[6]. Operating cash flow was $695.7 million, up from $570.6 million a year earlier, capital expenditures were $131.8 million, treasury stock purchases were $575.1 million, and cash, cash equivalents and restricted cash totaled $2.910 billion at the end of June[8]. The company said total debt was about $600 million at the end of June and about $1.5 billion remained under its repurchase authorization[3].

Operating Model

Edwards' revenue is the sum of three product groups, and each is roughly hospital procedure volume multiplied by Edwards' share and the average selling price. The company does not disclose these three variables numerically and describes them only qualitatively: its global competitive position "increased slightly" in the first quarter, mainly because a competitor left Europe, and average selling prices were stable globally[11]; in the second quarter its U.S. position rose modestly, with growth helped by clinical evidence supporting proactive management of severe aortic stenosis and long-term SAPIEN durability data[3]. The durable part of TAVR revenue therefore comes from more patients being diagnosed, referred and covered by insurance, with a lag set by hospital scheduling, while share gains are one-time and stop adding to year-over-year growth once they are in the base.

TMTT and surgical valves have different drivers, and currency affects reported revenue across all three lines. TMTT depends on the number of centers performing procedures and the volume at each center, and its 49.6% first-half growth came mainly from higher sales of PASCAL edge-to-edge repair, EVOQUE tricuspid replacement and SAPIEN M3 mitral replacement in the U.S. and Europe[8]; surgical valves grew 5.5% in constant currency in the first half on RESILIA tissue adoption[3]. A weaker dollar added $64.0 million to first-half reported sales[3], but management said currency would create about a $35 million sales headwind in the second half if current exchange rates hold[5].

On the profit side, the key questions are whether gross margin holds and how spending is phased through the year. The second-quarter adjusted gross margin was 77.6%, currency weighed on gross margin through the hedging program, and the company now sees full-year gross margin at the low end of its 78% to 79% guidance; in the same quarter SG&A was $561 million, or 32.2% of sales, and R&D was $279 million, or 16.0%, down from 18.0% a year earlier[3]. The company said first-half EPS benefited from "planned phasing" of R&D and SG&A through the year and still sees R&D at about 17% of sales for 2026[3]. Using the $6.75 billion midpoint of full-year revenue guidance, a 29% operating margin and first-half adjusted operating income of $1.041 billion, the implied second-half adjusted operating margin is about 27.3% and R&D about $605 million, or roughly $300 million a quarter[6].

Cash flow broadly tracks earnings, but the timing of payables and taxes can amplify or dampen it. Of the $1.595 billion of 2025 operating cash flow, $395.1 million came from higher payables and accrued liabilities[10], while the first half of 2026 went the other way, with payables and accrued liabilities down $223.4 million and receivables up $128.1 million[8]. Cash goes mainly to buybacks and to acquisitions of or investments in early-stage device companies, and impairments and remeasurement gains or losses on those investments flow into GAAP earnings but are excluded from adjusted results[6].

Industry and Competitive Position

Edwards considers itself a leading global competitor in every product line, but its rivals are all large device makers. Its primary TAVR competitors are Medtronic and Abbott, its primary TMTT competitor is Abbott, surgical valves also face Medtronic and Abbott, and many large and small companies are developing products in these fields[9]. After a competitor left the European TAVR market in Q2 2025, Edwards' global competitive position rose slightly in the first quarter of 2026, mainly in Europe[11].

Within TMTT, Edwards' main point of difference is that it offers both repair and replacement devices. MedTech Dive reported on October 23 that PASCAL had received U.S. FDA approval for tricuspid repair, and Leerink Partners analysts said this lets clinicians choose the more appropriate therapy for each patient between PASCAL repair and EVOQUE replacement[12]. In July the company also said it anticipated approval of next-generation PASCAL with Capture Clarity technology in the U.S. and Europe in the fourth quarter[3].

Reimbursement rules are a key variable in this industry, but in the near term they mainly improve efficiency at existing centers. The U.S. Centers for Medicare & Medicaid Services (CMS) has been reconsidering the National Coverage Determination (NCD) for TAVR, and in July the company said a final decision memo was anticipated in September[3]. As management described it, the draft creates a coverage pathway for asymptomatic patients and removes unnecessary evidence development requirements for symptomatic severe patients but keeps the requirement that TAVR programs be affiliated with cardiac surgery programs, so the main benefit is better operating efficiency at existing programs rather than a large number of new centers; management also said new indications such as asymptomatic and moderate aortic stenosis require gradual change in clinical practice and will not contribute meaningful revenue in the near term[5].

The available competitive comparison has clear limits. The company does not disclose procedure volume, share or average selling prices, so competitive position rests on management's qualitative statements, and regional sales include all product groups, so U.S. and European growth are only approximate proxies for TAVR. In the second quarter, U.S. sales grew 12.8% and European sales grew 11.7% in constant currency[3].

Core Debates

Once the share gained from a competitor's exit is in the base, how fast can Edwards' TAVR business keep growing?

This debate matters because TAVR is about three-quarters of Edwards' revenue, and third-quarter growth will decide whether the strong growth of 2025 and 2026 is read as a structural rise in procedure volume or a one-time share transfer[1]. TAVR grew 10.7% in constant currency in the first half of 2026, and the company raised full-year guidance to 8% to 9%[3], which implies only about 5% to 7% growth in the second half. The third quarter faces two comparison problems at once: the share gained from a competitor's exit in Europe enters the prior-year period, and Q3 2025 was itself unusually strong against normal summer seasonality[5].

The evidence supports improving demand but also shows that share transfer contributed meaningfully. The company attributes growth to clinical evidence for proactive management of severe aortic stenosis, long-term SAPIEN durability data and the competitor's exit; second-quarter growth was similar inside and outside the U.S., and average selling prices were stable globally[3]. In July management said plainly that reported growth in the second half would be pressured by the high comparison base from the second half of 2025[5]. The alternative explanation is that part of the late-2025 acceleration came from share transfer and seasonal distortion, and once both are in the base, underlying procedure growth could be only in the mid-single digits.

The numerical baselines show growth above 10% in each of the first two quarters against a high base in the prior-year second half. TAVR constant-currency growth was 11.0% in the first quarter and 10.5% in the second[11], and second-quarter TAVR sales were $1.258 billion; second-half 2025 TAVR sales were about $2.310 billion, derived as the full-year $4.488 billion minus the first-half $2.178 billion[3]. Based on the roughly $1.150 billion the company reported for the prior-year quarter, 5% growth in the third quarter corresponds to about $1.21 billion. In financial terms, diagnosis and referral determine procedure volume at existing centers, which multiplied by SAPIEN share and stable pricing produces TAVR sales and ultimately decides whether total revenue lands within the $1.63 billion to $1.71 billion third-quarter guidance range.

In the third quarter, the tests are whether TAVR sales reach at least about $1.21 billion with constant-currency growth of at least 5% to 7%, whether U.S. sales keep growing above 9%, and whether the company keeps its 8% to 9% full-year guidance and updates its comments on pricing, share and the final NCD. U.S. sales grew 12.8% in the second quarter[3], and if U.S. growth stays above 9% while Europe drops to single digits, the slowdown is mainly a comparison effect. If third-quarter constant-currency growth falls below 5%, or U.S. growth drops below 7%, the problem is more than the comparison, and even the 8% low end for the year would depend on a fourth-quarter acceleration.

Can Edwards' mitral and tricuspid business hold roughly $200 million a quarter through the summer slowdown?

TMTT is Edwards' fastest-growing business, and whether it keeps scaling determines the strength of the company's second growth engine. TMTT grew 49.6% in the first half of 2026[3], and the company targets about $2 billion in annual revenue by 2030[5]. Subtracting first-half sales of $373.7 million from full-year guidance of $760 million to $780 million leaves roughly $193 million to $203 million a quarter in the second half, about flat with the second quarter[3], so the third quarter mainly tests whether second-quarter strength carries through the summer slowdown.

Second-quarter results beat the company's own expectations, but they may include one-time factors. Second-quarter TMTT sales were $198.6 million, including $2.7 million of implantable heart failure management revenue; EVOQUE is expanding through new centers, deeper use at existing centers and streamlined patient screening, while SAPIEN M3 is opening centers steadily in a measured launch[3]. Management said all three platforms, PASCAL, EVOQUE and SAPIEN M3, grew faster than expected, with double-digit global procedure growth[5]. The alternative explanation is that the second quarter included initial stocking or concentrated training as new centers opened, so the third quarter could decline sequentially, leaving full-year guidance dependent on the fourth-quarter U.S. launch of PASCAL for tricuspid patients.

From the fourth quarter TMTT gains a new growth source, along with a safety event that needs tracking. MedTech Dive reported that the FDA approved PASCAL's tricuspid indication in October[12]; also in October, the FDA issued an early alert on certain lots of the delivery system used with SAPIEN M3, and the company notified customers to remove the affected lots, an event that came after the third quarter and does not directly affect third-quarter revenue but will shape how management describes the pace of M3 center openings. The baselines are second-quarter TMTT sales of $198.6 million and second-half 2025 sales of about $300.9 million, derived as the full-year $550.6 million minus the first-half $249.7 million[1]; based on the company's prior-year disclosure, Q3 2025 TMTT sales were about $145 million.

In the third quarter, the tests are whether TMTT reaches at least about $193 million, whether the $760 million to $780 million full-year guidance holds, how the company describes each of the three platforms and procedure growth, and how the U.S. tricuspid launch of PASCAL is progressing. If third-quarter TMTT falls below $185 million, reaching the low end for the year would require a record fourth quarter. If more M3 lots are affected or new center openings pause, the M3 ramp will be delayed.

Is Edwards' first-half operating margin above 30% a sign of improvement, or just spending that has been deferred?

This debate decides whether the first-half margin can be treated as a new normal. Edwards' first-half adjusted operating margin was 30.7%[6] and R&D was only 16.0% of revenue, but the company kept full-year guidance for an operating margin at the high end of 28% to 29% and R&D of about 17%, and said the first half benefited from planned phasing of R&D and SG&A[3]. That means the second-half adjusted operating margin needs to fall to about 27% and R&D needs to rise to about $300 million a quarter; if spending rises on schedule and EPS meets guidance in the third quarter, the decline is planned investment, but if spending does not rise and margin stays high, the investment has been pushed out.

Spending, currency and the tax rate all act on second-half profit at once. The 10-Q attributes higher R&D to investment in implantable heart failure management and advanced technology[8]. A weaker dollar added $64.0 million to first-half reported sales but depressed gross margin through the hedging program, and the company now sees full-year gross margin at the low end of 78% to 79% and its adjusted tax rate at the high end of 16% to 19%[3], while management also flagged about a $35 million second-half sales headwind from currency[5]. The alternative explanation is that part of the first-half margin came from operating leverage on better-than-expected revenue, and if second-half revenue growth slows against the high base while spending rises as planned, margin could fall below the company's implied level.

The numerical baselines show margin and EPS running high in both of the first two quarters. Adjusted operating margin was 31.4% in the first quarter and 30.0% in the second, and adjusted EPS was $0.78 in both quarters[11]; Drillr's earnings calendar records Q3 2025 adjusted EPS of $0.67[2], and first-half 2026 R&D was $542.2 million, with about $263 million in the first quarter and $279 million in the second[8]. In financial terms, the planned second-half increase in R&D and SG&A and the lagged hedging drag on gross margin together pull the adjusted operating margin from 30.7% in the first half to about 27% in the second, which flows into adjusted EPS guidance of $0.71 to $0.77 for the third quarter and $2.95 to $3.05 for the year[3]. On roughly $3.36 billion of second-half revenue, each 1 percentage point of lower adjusted operating margin removes about $34 million of operating income, or about $0.05 per share at a 19% tax rate and about 570 million shares.

In the third quarter, the tests are whether the adjusted operating margin lands at about 26.5% to 29.5%, whether adjusted EPS reaches at least the $0.74 guidance midpoint, whether R&D rises above about $290 million and 17% of revenue, and whether the adjusted gross margin holds near 77.8%. If revenue slows while spending rises, the margin decline could exceed the roughly 27% implied level. If the adjusted gross margin falls below 77%, the full-year margin guidance would be weakened.

Risks and Falsifiers

The first risk is that impairments on strategic investments and litigation costs keep recurring and keep depressing GAAP earnings. Intellectual property agreement and certain litigation expenses were $325.4 million in 2025[10], including costs related to the JenaValve deal after the court blocked it[7]; in the first half of 2026 the company recorded a further $163.6 million of impairments on variable interest entity investments, leaving first-half GAAP operating income of $990.8 million about $50 million below the adjusted $1.041 billion, and GAAP EPS of $1.07 against adjusted EPS of $1.56[6]. Edwards holds options on or investments in several early-stage device companies, and its decisions on exercising them can bring further impairments or remeasurement gains and losses; if later quarters show no new investment impairments or large litigation charges and the gap between GAAP and adjusted EPS narrows to within $0.05, this risk is falsified.

The second risk is that once the share gain is in the base, TAVR growth falls below the second-half level implied by guidance, showing that part of the late-2025 acceleration was not sustainable. TAVR is about 74% of revenue[1], and against a second-half 2025 base of about $2.310 billion, each percentage point of slower second-half growth removes about $23 million of revenue. If third-quarter TAVR constant-currency growth is at least 7% and U.S. sales growth is at least 9%, this concern does not hold.

The third risk is that the SAPIEN M3 delivery system lot problem widens, slowing new center openings or pushing physicians toward other options. M3 is one of TMTT's three main platforms[8], and full-year TMTT guidance implies about $386 million to $406 million of second-half revenue[3]; a slower M3 pace would reduce incremental growth in the fourth quarter and in 2027, and the company does not disclose M3 revenue separately. If the company confirms in its third-quarter report that the affected lots have been removed and new center openings are on plan, this risk weakens.

The fourth risk is that second-half revenue growth slows against the high base while R&D and SG&A rise as planned, so the operating margin falls further than guidance implies. Management has already warned that second-half reported growth faces pressure from a high comparison base[5], and by the calculation above each percentage point of lower second-half adjusted operating margin equals about $0.05 per share. If the third-quarter adjusted operating margin is at least 26.5% and full-year EPS guidance is maintained, this risk is falsified.

What to Watch Next

• TAVR growth: third-quarter TAVR sales and constant-currency growth against $1.258 billion and 10.5% in Q2 and 10.7% in the first half; at least 7% supports improving demand, while below 5% means the acceleration was not sustainable.
• TAVR growth: U.S. sales growth against 12.8% in Q2 and 12.3% in the first half; above 9% points to a comparison effect, while below 7% points to slowing demand.
• TAVR growth: whether full-year TAVR guidance of 8% to 9% in constant currency, or $4.75 billion to $5.0 billion, holds, and how management describes the coverage decision's effect on scheduling and referrals.
• TMTT through the slowdown: third-quarter TMTT sales against $198.6 million in Q2 and full-year guidance of $760 million to $780 million; at least $193 million confirms, below $185 million weakens.
• TMTT through the slowdown: the U.S. tricuspid launch of PASCAL after its October approval, and whether the SAPIEN M3 lot removal affects the pace of new center openings.
• Margin: third-quarter adjusted operating margin and EPS against 30.7% in the first half and $0.71 to $0.77 EPS guidance; 26.5% to 29.5% with EPS of at least $0.74 confirms, below 26.5% weakens.
• Margin: R&D against $279 million, or 16.0% of sales, in Q2, and adjusted gross margin against 77.6%; R&D above about $290 million signals planned investment, while gross margin below 77% weakens the outlook.

Conclusion

Edwards' business is driven by TAVR, which generated $4.488 billion in 2025, or 74% of $6.068 billion in continuing-operations sales, while TMTT is the faster-growing second engine[1]. The company's finances are solid, with 2025 operating cash flow of $1.595 billion[10] and, at the end of June 2026, about $2.9 billion of cash against about $600 million of total debt[3]. The central unresolved relationship is how fast underlying TAVR procedure growth runs once the share gained from a competitor's exit is in the base, and how far the planned second-half increase in spending pulls the margin back.

Independent outside commentary since the latest results is sparse and covers only one of the debates. The only independent view found is Leerink Partners' assessment, reported by MedTech Dive on October 23, that PASCAL's tricuspid approval should "strengthen the company's position in the large and underpenetrated transcatheter tricuspid market" and lets clinicians choose between repair and replacement[12]. That outside interpretation supports the view that TMTT gains a new growth source from the fourth quarter, but it addresses long-term market position rather than third-quarter TMTT revenue and does not discuss TAVR growth or margin; coverage of the CMS coverage decision and the SAPIEN M3 delivery system alert was largely factual, leaving no independent judgment to compare on those two questions.

The current understanding would be materially strengthened by a combination of third-quarter observations: TAVR constant-currency growth of at least 7% with U.S. growth of at least 9%, TMTT of at least about $193 million, and R&D rising on schedule above about $290 million while the adjusted operating margin stays above 26.5%. Conversely, if U.S. TAVR growth drops below 7%, TMTT falls below $185 million and spending rises as planned to push the margin below 26.5%, the strong growth of 2025 and 2026 would look more like a one-time share transfer, and the current understanding would need significant revision.

Sources

[1] EW FY2025 10-K filed 2026-02-25 · 2026-02-25 · 10-K · https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/

[2] EW earnings calendar updated 2026-10-30 · 2026-10-30 · Drillr earnings calendar

[3] EW Q2 2026 8-K filed 2026-07-23 · 2026-07-23 · 8-K · https://www.sec.gov/Archives/edgar/data/0001099800/000109980026000038/ex-991q22026.htm

[4] Drillr analyst estimates EW Q3 2026 retrieved 2026-10-30 · 2026-10-30 · Drillr analyst_financial_estimates · https://gateway.drillr.ai/mcp/private

[5] EW Q2 2026 earnings call 2026-07-23 · 2026-07-23 · earnings-call · https://ir.edwards.com

[6] EW Q2 2026 8-K GAAP to adjusted reconciliation · 2026-07-23 · 8-K · https://www.sec.gov/Archives/edgar/data/0001099800/000109980026000038/ex-991q22026.htm

[7] EW FY2025 10-K JenaValve and liquidity · 2026-02-25 · 10-K · https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/

[8] EW Q2 2026 10-Q filed 2026-08-04 · 2026-08-04 · 10-Q · https://www.sec.gov/Archives/edgar/data/1099800/000109980026000043/

[9] EW FY2025 10-K sales, manufacturing and competition · 2026-02-25 · 10-K · https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/

[10] EW FY2025 10-K income statement and cash flow · 2026-02-25 · 10-K · https://www.sec.gov/Archives/edgar/data/1099800/000109980026000009/

[11] EW Q1 2026 8-K filed 2026-04-23 · 2026-04-23 · 8-K · https://www.sec.gov/cgi-bin/browse-edgar?action=getcompany&CIK=0001099800&type=8-K

[12] MedTech Dive Leerink view on PASCAL tricuspid approval 2026-10-23 · 2026-10-23 · MedTech Dive · https://www.medtechdive.com/news/edwards-wins-fda-approval-for-tricuspid-valve-repair-device/833815/