The Weekly

The Valve Wire Weekly

Week of July 5 – July 11, 2026

Week in Review

This was the week policy started moving faster than the guidelines. On Monday, the Centers for Medicare & Medicaid Services (CMS) reopened its National Coverage Analysis for transcatheter aortic valve replacement (TAVR); by Thursday, the agency floated explicit Medicare coverage for asymptomatic severe aortic stenosis — effectively porting the EARLY TAVR trial straight into the reimbursement code and dragging US practice toward the European posture on early intervention while the American guideline still recommends watchful waiting for most of these patients. That happened alongside a peer-reviewed meta-analysis reaffirming that TAVR and surgical valve replacement have similar mortality in lower-risk patients, but with two- to five-fold higher rates of pacemakers, reinterventions, and vascular complications after TAVR. Meanwhile, the tricuspid device franchise Edwards Lifesciences essentially owned six months ago became a contested market overnight, as TRiCares dosed the first patient in a randomized head-to-head trial against Edwards' EVOQUE system, Jenscare's LuX-Valve Plus took European CE mark, and Laplace Interventional registered a separate 700-patient pivotal. Real-world data from the STS/ACC TVT Registry showed 30-day mortality of 23.7% for transcatheter mitral replacement in native calcified valves — a reminder that dispersion of complex procedures is outpacing the outcomes literature. And Edwards closed the week at $92.21, underperforming peers into its July 23 earnings print.

Top Stories This Week

[NOTABLE] CMS Proposes Medicare Coverage for Asymptomatic Severe Aortic Stenosis

CMS reopened the TAVR National Coverage Analysis (CAG-00430R) on July 6 and by July 9 had escalated to a substantive proposal: extending Medicare coverage to asymptomatic severe aortic stenosis. If finalized, this would operationalize the EARLY TAVR trial signal into reimbursement policy — the first time in recent memory US payment has moved ahead of the US clinical guideline. The 2025 European Society of Cardiology (ESC) guideline already made early intervention Class IIa (LOE A) for asymptomatic severe AS at low procedural risk, based on the EARLY TAVR, RECOVERY, AVATAR, and EVoLVeD trials. The 2020 American College of Cardiology / American Heart Association (ACC/AHA) guideline restricts early intervention to specific subgroups (very severe AS, elevated BNP, abnormal exercise test). Expect friction over which asymptomatic populations qualify, heart team documentation, and volume thresholds during the public comment window. Read the CMS coverage proposal coverage at Cardiovascular Business.

Updated Meta-Analysis: TAVR Ties SAVR on Mortality, Loses on Pacemakers, Reinterventions, and Vascular Complications

A systematic review and meta-analysis published in Open Medicine (Rashid K et al., July 9) pooled randomized trials of TAVR versus surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from 2017–2024. Mortality was numerically lower with TAVR but not statistically different (relative risk 0.88, 95% CI 0.62–1.25, p=0.49). TAVR was associated with more than double the rate of permanent pacemaker implantation (RR 2.19, 95% CI 1.55–3.16), reintervention (RR 2.51, 95% CI 1.40–4.51), and new bundle branch block (RR 2.10, 95% CI 1.21–3.67), and nearly five-fold higher vascular complications (RR 4.77, 95% CI 2.11–10.81). TAVR reduced new-onset atrial fibrillation (RR 0.29, 95% CI 0.23–0.38). Heterogeneity was substantial for several endpoints (I² 62–84%). Mortality parity is what the ESC leaned on to move the TAVI-preferred threshold to age 70. The pacemaker, reintervention, and vascular signals are what the ACC/AHA under-65 SAVR preference was designed to avoid. Neither guideline is vindicated. Read the meta-analysis.

[NOTABLE] First Randomized Head-to-Head Between Transcatheter Tricuspid Replacement Platforms Dosed

TRiCares dosed the first patient in the TRICURE US IDE pivotal trial on July 10 at Piedmont Healthcare (operator: Pradeep Yadav). The study randomizes the Topaz transcatheter tricuspid valve replacement (TTVR) system against Edwards' EVOQUE in patients with severe or greater tricuspid regurgitation and femoral vein access. Separately, Laplace Interventional registered a 700-patient pivotal (NCT07687485), also using EVOQUE as the active comparator. The tricuspid replacement category the ESC 2025 elevated to Class IIa (LOE A) — based largely on TRISCEND II — now has a real competitive market. The ACC/AHA 2020 guideline doesn't address transcatheter TR therapy at all. The STS/ACC TVT Registry EVOQUE readout earlier this year showed 98.4% technical success, 3.1% 30-day mortality, and 15.9% new pacemaker implantation in patients without pre-existing devices. That's the benchmark Topaz must beat, and pacemaker rate is the likely competitive wedge. Read the TRICURE announcement at Cardiovascular Business.

LAMPOON in the Real World: 95.5% Technical Success, 23.7% 30-Day Mortality in Valve-in-MAC

A STS/ACC TVT Registry analysis of 9,250 transcatheter mitral valve replacement (TMVR) procedures at 569 US sites showed the LAMPOON leaflet-splitting technique prevented left ventricular outflow tract obstruction in 95.5% of cases where applied. But 30-day mortality was 23.7% in valve-in-MAC (mitral annular calcification), 8.3% in valve-in-valve, and 6.1% in valve-in-ring cases. One-year mortality in native-valve TMVR exceeded 40%. LAMPOON is now performed at 29.2% of US TMVR sites (8.9% of cases), with 61 sites reporting only a single case. Technically the technique works. Clinically, TMVR in native calcified mitral valves remains salvage therapy, not a democratized alternative to surgery. Both ACC/AHA 2020 and ESC 2025 anchor mitral therapy on surgical repair; this week's data reinforce that transcatheter mitral replacement should stay confined to inoperable anatomy. Discussants at New York Valves 2026 — Villablanca, Whisenant, Adams — converged on regionalization. Read the LAMPOON registry analysis at TCTMD.

TAVR Matches Surgical Valve Durability at 7 Years

Newly reported registry-level follow-up extends TAVR-vs-SAVR durability parity to 7 years, per Medscape's coverage. The ACC/AHA 2020 under-65 SAVR preference rested on TAVR durability data extending only to about 5 years; that assumption is now weaker. ESC 2025 already moved the TAVI-preferred floor to 70. Caveat: durability parity in trial-eligible populations doesn't automatically extend to bicuspid anatomy, small annuli requiring enlargement, or concomitant aortopathy — where both guidelines still favor surgery. Durability was the last surgical redoubt in the age-threshold debate. Its erosion doesn't settle the question; it moves the argument to bicuspid, small annulus, and lifetime management.

Aortic Valve (TAVR/TAVI)

Aortic valve news dominated the week, shaped by the CMS reopening and a cluster of real-world and mechanistic studies pushing on the ACC/AHA vs ESC age-threshold gap.

Durability and Coverage

The 7-year TAVR-vs-SAVR durability parity signal via Medscape landed alongside the Rashid meta-analysis in Open Medicine and a Circulation midterm bicuspid TAVR report referenced but not fully quantified in the digest. Together the three sources tighten the case for TAVR in older patients but do not resolve the sub-70, bicuspid, or small-annulus populations. A narrative review by Sharma and colleagues in Reviews in Cardiovascular Medicine confirmed the international guideline divergence: US ACC/AHA favors SAVR under 65; ESC pivots at 70 (formerly 75); Asia-Pacific centers weight bicuspid and rheumatic anatomy first.

PORTICO IDE 5-Year: Small Annuli Favor Self-Expanding, Intra-Annular Design

Core-lab analysis from the PORTICO IDE trial (N=675, industry-sponsored, high/extreme-risk) published in EuroIntervention showed that in small annuli, severe patient-prosthesis mismatch was 3.3% with Portico versus 26.3% with SAPIEN 3 (p<0.0001), and 5-year structural valve deterioration was 2.2% versus 13.9% (p<0.0001). Portico matched Evolut on effective orifice area. This is the granular durability data the SAVR-vs-TAVR debate rarely gets; the high-risk enrollment limits extrapolation to low-risk populations now driving indication creep. Read the PORTICO IDE analysis.

Institutional Volume Predicts Outcomes

A Vizient analysis of 91,494 TAVR procedures across 118 US hospitals from 2022–2024, published in Catheterization and Cardiovascular Interventions, found higher institutional volume was independently associated with shorter length of stay every year and, in 2024, lower observed mortality after case-mix-index adjustment (ANCOVA p<0.0001). Directly relevant to the CMS reconsideration: if the NCA rewrite tightens volume thresholds, this is the evidentiary anchor. Read the Vizient analysis.

SAFER-TAVI: Radial Secondary Access Cuts Complications, Misses Composite

The SAFER-TAVI trial (N=542, three Melbourne centers, open-label) randomized radial versus contralateral femoral secondary access in TAVR. Secondary-site vascular complications: 0.7% radial versus 3.3% femoral. The composite primary+secondary bleeding endpoint did not reach significance, and radiation dose was higher in the radial arm. The second stick still accounts for roughly a fifth of TAVR vascular events; radial secondary access should be the default despite the composite miss. Read the SAFER-TAVI coverage at TCTMD.

Obesity Paradox Is a Frailty Signal

A JACC Advances analysis of 6,639 STS/ACC TVT Registry patients (Kumar S, Naik H, Falluji N; retrospective) reframed the "obesity paradox" in TAVR as an age-driven frailty phenotype. Lower BMI (<25 kg/m²) was associated with 29% higher 1-year mortality in patients ≥65 (adjusted hazard ratio 1.20, 95% CI 1.05–1.57), and the effect strengthened in patients ≥85 (aHR 0.36 for BMI ≥25, 95% CI 0.25–0.51). The effect did not hold in younger patients. Read the JACC Advances analysis.

Coronary Functional Assessment Adds Prognostic Value

A BMC Medical Imaging single-center analysis of 329 patients showed CT-derived fractional flow reserve (CT-FFR) ≤0.80 pre-aortic valve replacement independently predicted major adverse cardiac events (HR 4.84) across both TAVR and SAVR cohorts, outperforming anatomical CT coronary angiography alone. Read the CT-FFR study.

Other Aortic Reports

A single-center Myval registry (N=214, retrospective, no comparator) reported 97.7% procedural success and 3.4% structural valve deterioration at up to 3 years, extending 1-year LANDMARK trial non-inferiority signals into routine practice.
A JCF state-of-the-art review argued guideline-directed medical therapy — renin-angiotensin system inhibitors and SGLT2 inhibitors in particular — is inconsistently continued across the TAVR continuum, despite persistent post-TAVR heart failure. Read the review.
An Echocardiography analysis of ~100,000 paired ECG/echo encounters (EchoNext cohort) identified QRS duration and age as independent predictors of aortic stenosis and aortic regurgitation progression.
A German registry (N=32) of fully percutaneous transaxillary TAVR using off-label MANTA or double-ProGlide closure reported a 25% vascular closure device failure rate. Read the registry.
A composite AI-ECG model presented at New York Valves 2026 detected structural heart disease across ~124,000 patients in South Korea, Colombia, and the UK Biobank with 71.8–76.1% sensitivity, and identified patients 2.75–3.75-fold more likely to develop incident SHD over 6 years. Read the TCTMD coverage.

Mitral Valve (Repair & Replacement)

Mitral news was dominated by the LAMPOON real-world data and the ongoing tension between the ESC 2025 Class I upgrade for transcatheter edge-to-edge repair (TEER) in ventricular secondary MR and the ACC/AHA 2020 Class IIa language.

LAMPOON Real-World

The STS/ACC TVT Registry LAMPOON analysis (see Top Stories) is the most consequential mitral read of the year. 30-day mortality of 23.7% in valve-in-MAC and 1-year mortality exceeding 40% in native-valve TMVR reinforce that this technique belongs in inoperable anatomy, not in operable primary MR where surgical repair remains Class I in both guidelines. Read the LAMPOON registry analysis at TCTMD.

Octogenarian Mitral Surgery: 3% Repair Mortality

A single-center retrospective series in the Journal of Thoracic and Cardiovascular Surgery (Patil R et al., N=221, 2015–2024) reported 3% operative mortality after mitral valve repair versus 11% after replacement in octogenarians (p=0.04). In the degenerative MR subgroup (N=168), operative mortality was 1.2% regardless of procedure. Median STS predicted risk of mortality was 5%. Mid-term survival favored repair out to 4 years. Neither ACC/AHA 2020 nor ESC 2025 exempts octogenarians from surgical repair when durable results are expected. This is the benchmark TEER should be measured against in this age group — not simply presumed to beat. Read the JTCVS series.

Case-Level Signals

Dual PASCAL ACE TEER restored coaptation in a functionally trileaflet mitral valve with a 3 mmHg residual gradient in a 67-year-old with prior AV canal repair — off-label anatomy handled successfully but without comparative data. Read the JACC Case Reports write-up.
A DragonFly TEER case in a 90-year-old with mixed degenerative and atrial functional MR illustrated the anatomical ceiling for multi-clip TEER. Read the case.
A hybrid TEER-plus-vascular-plug case for commissural degenerative MR showed the anatomical limits of edge-to-edge repair. Read the case.
A TMVR valve-in-valve rescue under Impella support for cardiogenic shock from bioprosthetic leaflet tear extended the emerging use case for percutaneous mitral reintervention. Read the case.
A JACC Imaging editorial reinforced the residual MR–mean gradient trade-off in TEER — neither endpoint alone captures durable benefit. Read the editorial.

Tricuspid Valve (Repair & Replacement)

The tricuspid space was the week's biggest structural story after CMS — a competitive replacement market opened, CE mark arrived for a second device, and case reports began accumulating on procedural physics.

Competitive Replacement Market Opens

The TRICURE US IDE launch (TRiCares Topaz vs Edwards EVOQUE, first patient at Piedmont Healthcare) and Laplace Interventional's registered 700-patient pivotal against EVOQUE mean the one-device tricuspid market is over. Jenscare's LuX-Valve Plus obtained European CE mark during the week, opening a second European commercial pathway alongside EVOQUE. Whether that produces better devices or a race to lower pacemaker rates over durability discipline is the open question.

Timing of Intervention

An Open Heart analysis (N=93, retrospective) showed adding RV–pulmonary artery coupling (TAPSE/PASP <0.44) to the TRI-SCORE improved model discrimination (C-index 0.614 → 0.710) in isolated TR. An AI-driven Brazilian cohort of 803 severe TR patients reinforced the late-referral problem: 17.1% mortality, median EuroSCORE II 13.4%, median TRI-SCORE 7. Patients are still arriving too sick. Read the RV-PA coupling study. Read the Brazilian cohort.

Case Literature Accumulates

JACC Case Reports published a mini-focus on tricuspid procedural complications:

Valve-in-valve for early Topaz TTVR leaflet dysfunction at 6 months. Read the case.
Acute EVOQUE leaflet thrombosis with PFO-mediated hypoxemia. Read the case.
First documented fatal prosthetic valve endocarditis after TTVR. Read the case.
First left-sided transvenous pacemaker through a TricValve bicaval prosthesis in a PACE report — nitinol struts crossed successfully but sets a new procedural precedent. Read the PACE case.
Iatrogenic ASD unmasked by bicaval valve implantation, closed percutaneously. Read the case.
Dual coronary sinus lead biventricular pacing to avoid crossing prosthetic tricuspid valves in three patients. Read the PACE report.

The ESC 2025 Class IIa (LOE A) elevation for transcatheter TR treatment rests on TRILUMINATE Pivotal, Tri.Fr, and TRISCEND II — trials that captured 30-day and 1–2 year endpoints. This week's case series show what happens when devices meet real anatomy and time. Early durability, antithrombotic regimens, and downstream pacing all remain unresolved. The ACC/AHA 2020 guideline does not address transcatheter TR therapy.

ACHD and Anatomic Constraints

A Methodist DeBakey review catalogued the anatomic obstacles — anomalous venous return, distorted transseptal geometry, systemic tricuspid morphology in congenitally corrected transposition — that make published TR TEER outcomes non-generalizable to adult congenital heart disease. Read the review.

Surgical vs. Transcatheter Comparisons

Three convergent signals this week sharpened the surgical counterpoint even as reimbursement expanded transcatheter access.

First, the Rashid meta-analysis: TAVR and SAVR are mortality-equivalent in low- and intermediate-risk symptomatic severe AS, but the endpoint hierarchy that matters to durability — pacemaker (RR 2.19), reintervention (RR 2.51), vascular complications (RR 4.77) — all favor SAVR. TAVR wins on new-onset atrial fibrillation (RR 0.29). The Sharma review reinforced that observational US data show TAVR use rising in patients under 65 despite ACC/AHA preference for surgery, with worse long-term mortality and higher pacemaker/readmission burdens in selected cohorts.

Second, the octogenarian mitral surgery series: 1.2% operative mortality in degenerative MR at a high-volume center is the benchmark TEER should be measured against in this age group.

Third, the Vizient volume-outcome analysis: a low-volume TAVR program may not be safer than a high-volume surgical program for the same patient. The LAMPOON registry extended the same logic to TMVR.

The 7-year TAVR durability parity narrative moves the age-threshold debate; it does not settle bicuspid, small-annulus, or concomitant aortopathy — where both ACC/AHA 2020 and ESC 2025 continue to favor surgery.

Clinical Trials Update

Aortic Valve Trials

NCT07689279 — STHL-IS (Selection of Transcatheter Heart Valve With Intermediate Sizing). Status: Not Yet Recruiting. Phase 4. Enrollment: 604. Sponsor: Academisch Medisch Centrum – Universiteit van Amsterdam. Addresses annulus sizing decisions between adjacent valve sizes.
NCT05172960 — ALLIANCE (SAPIEN X4). Status: Recruiting. Enrollment: 1,234. Sponsor: Edwards Lifesciences. Next-generation balloon-expandable platform.
NCT06008080 — Navitor Post-Market Follow-Up. Status: Recruiting. Enrollment: 1,000. Sponsor: Abbott Medical Devices.
NCT07566624 — Spanish Hydra THV Registry. Status: Recruiting. Enrollment: 100. Sponsor: Fundación EPIC.
NCT07477002 — Post-Dilatation in Balloon-Expandable TAVI Prostheses. Status: Active, Not Recruiting. Enrollment: 146. Sponsor: Medical University of Vienna.
NCT07042529 — OptEx-TAVI. Status: Recruiting. Enrollment: 1,010. Sponsor: Ole De Backer.
NCT07696182 — EncantoR Software-Guided AVR. Status: Not Yet Recruiting. Enrollment: 150. Sponsor: Abbott Medical Devices.
NCT06608823 — ARTIST (Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™). Status: Recruiting. Enrollment: 1,016. Sponsor: JenaValve Technology.
NCT07194265 — DurAVR THV Pivotal. Status: Recruiting. Enrollment: 1,650. Sponsor: Anteris Technologies. Comparator: SAPIEN or Evolut series.
NCT04728698 — PARTNER 3 Low Risk 5-Year Follow-Up. Landmark trial.
NCT02701283 — Evolut Low Risk Long-Term Follow-Up. Status: Active, Not Recruiting. Enrollment: 2,223. Sponsor: Medtronic. Landmark.

Mitral Valve Trials

NCT04198870 — REPAIR-MR (MitraClip vs surgery for primary MR). Status: Active, Not Recruiting. Enrollment: 500. Sponsor: Abbott. Landmark.
NCT05051033 — PRIMARY (MitraClip vs medical therapy for secondary MR). Status: Active, Not Recruiting. Enrollment: 450. Landmark.
NCT03706833 — Edwards PASCAL CLASP IID/IIF Pivotal. Status: Active, Not Recruiting. Enrollment: 1,247. Sponsor: Edwards Lifesciences.
NCT05496998 — APOLLO-EU (Intrepid TMVR TF). Status: Recruiting. Enrollment: 400. Sponsor: Medtronic. Landmark.
NCT03242642 — Intrepid TMVR Pivotal. Status: Recruiting. Enrollment: 1,056. Sponsor: Medtronic. Landmark.

Tricuspid Valve Trials

NCT07687485 — LAPLACE TTVR Pivotal. New this week. Status: Not Yet Recruiting. Enrollment: 700. Sponsor: Laplace Interventional. Active comparator: Edwards EVOQUE. First registered head-to-head TTVR platform comparison alongside TRICURE.
TRICURE US IDE (TRiCares Topaz vs Edwards EVOQUE). First patient dosed July 10 at Piedmont Healthcare. Announcement.
NCT07691307 — TruGamma Tricuspid Replacement. Status: Recruiting. Enrollment: 180. Sponsor: Jiangsu Trulive Medical.
NCT06458907 — TricValve Bicaval RCT. Status: Not Yet Recruiting. Enrollment: 780. Sponsor: P+F Products + Features USA.
NCT03904147 — TRILUMINATE Pivotal (TriClip). Status: Active, Not Recruiting. Enrollment: 572. Landmark.
NCT04097145 — CLASP II TR (PASCAL for TR). Status: Recruiting. Enrollment: 1,270. Sponsor: Edwards. Landmark.
NCT04482062 — TRISCEND II (EVOQUE). Status: Active, Not Recruiting. Enrollment: 864. Sponsor: Edwards. Landmark.
NCT03745313 — Edwards CLASP TR EFS. Status: Completed. Enrollment: 65. Status updated to Completed this week.

Valve Industry Stocks — Weekly Performance

6-Month Valve Industry Stock Performance

Edwards Lifesciences (EW)

Friday close: $92.21. Weekly change: approximately -$2.16 (-2.3%) from July 3.
6-month change: +11.08%. 52-week range: $72.30–$96.29.
Market cap $52.5B; trailing P/E 48.77; forward P/E 27.08; beta 0.85.
Analyst consensus: Buy. Target $97.92 (range $84–$110, 26 analysts).
Next earnings: July 23, 2026. Consensus EPS $0.74, revenue $1.70B.
Underperformance late in the week coincided with the TRICURE IDE launch — the first direct EVOQUE competition — and with the release of a $39M investor litigation settlement moving toward first approval. Edwards is the most direct beneficiary of the CMS asymptomatic AS proposal but faces new TTVR franchise pressure heading into Q2 earnings.

Medtronic (MDT)

Friday close: $83.87. 6-month change: -12.00%. 52-week range: $73.31–$106.33.
Market cap $106.2B; trailing P/E 21.83; forward P/E 12.95; beta 0.58.
Analyst consensus: Buy. Target $97.73 (range $78–$121, 26 analysts).
Next earnings: August 18, 2026. Consensus EPS $1.39, revenue $9.55B.
Medtronic issued a safety-risk recall on a heart valve delivery system during the week — device family and FDA classification pending. Recall coverage. TD Cowen also cut its MDT price target citing TAVR headwinds. TD Cowen coverage.

Abbott (ABT)

Friday close: $93.93. 6-month change: -23.78%. 52-week range: $81.97–$137.49.
Market cap $164.4B; trailing P/E 26.59; forward P/E 15.59; beta 0.61.
Analyst consensus: Buy. Target $116.40 (range $92–$135, 25 analysts) — implied ~24% upside.
Next earnings: July 16, 2026. Consensus EPS $1.28, revenue $12.52B.
Abbott's MitraClip and TriClip franchises benefit directly from the ESC 2025 Class I upgrade for TEER in ventricular SMR and Class IIa for transcatheter TR treatment. The 24% six-month decline reflects diagnostics and nutrition pressure rather than structural heart weakness.

Boston Scientific (BSX)

Friday close: $44.77. 6-month change: -53.23%. 52-week range: $42.25–$109.50.
Market cap $67.2B; trailing P/E 19.01; forward P/E 12.19; beta 0.58.
Analyst consensus: Strong Buy. Target $73.86 (range $55–$106, 29 analysts) — implied ~65% upside if thesis holds.
Next earnings: July 29, 2026. Consensus EPS $0.83, revenue $5.37B.
The widest analyst-vs-tape disconnect in structural heart. The July 29 print will test whether the WATCHMAN-driven drawdown reflects a fundamental deceleration or a positioning washout.

Anteris Technologies (AVR.AX)

Friday close: A$13.34. 6-month change: +91.39%. 52-week range: A$4.68–$15.47.
Market cap A$1.3B; forward P/E -6.28 (pre-revenue); beta 0.73.
Analyst coverage: one analyst, target A$13.00 — below current price.
DurAVR THV positioning targets durability-conscious and bicuspid segments where SAVR still dominates per current guidelines. Speculative small-cap; catalyst-driven.

Private company footnote: JenaValve Technology (ARTIST trial sponsor), J Valve Technology, and Meril Life Sciences (Myval platform) remain private and outside the public tape. Meril's LANDMARK 1-year data showed non-inferiority to SAPIEN/Evolut — a competitive event for Edwards and Medtronic that public investors cannot participate in but should track.

Weekly outlook: Three earnings catalysts fall inside the CMS comment window — Abbott (July 16), Edwards (July 23), and Boston Scientific (July 29). Medtronic reports August 18. Any hint from CMS that asymptomatic AS coverage will be finalized in current form is a direct Edwards positive; any hint of tighter volume thresholds fragments TAVR growth away from community centers.

Regulatory & Policy

The CMS reopening of the TAVR National Coverage Analysis and proposed extension to asymptomatic severe AS is the most consequential US structural heart policy event of the year. If finalized, US reimbursement will move ahead of the ACC/AHA 2020 guideline and align with the ESC 2025 Class IIa early-intervention pathway. Public comment period focus points: (1) which asymptomatic populations qualify (EARLY TAVR criteria versus broader definitions), (2) heart team documentation requirements, and