Cardiovascular Today—April 16, 2026

This week’s Cardiovascular update highlights regulatory approvals, pivotal trial progress, device launches, and emerging data shaping heart failure and structural heart care.

In Today’s Newsletter

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🫀 MiRus starts STAR trial for Siegel 8Fr TAVI [1] [US • 13 Apr 2026]

https://cardiovascularnews.com/randomised-trial-of-8fr-tavi-system-gets-underway/
Context: Prospective, multicentre, randomised controlled trial in severe symptomatic aortic stenosis, across low, intermediate, and high surgical-risk groups; planned n=1,025.
Key point: MiRus announced first patient enrolment and treatment in STAR, comparing the Siegel 8Fr transcatheter heart valve with commercial balloon-expandable or self-expanding THVs.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 STORM-PE reports better 90-day function with CAVT plus anticoagulation [2] [Canada • 14 Apr 2026]

https://cardiovascularnews.com/new-storm-pe-data-show-improved-functional-outcomes-with-cavt-plus-anticoagulation/
Context: Randomised, prospective, multicentre trial, n=100 across 22 international sites, evaluating Penumbra’s Lightning Flash plus anticoagulation versus anticoagulation alone in acute intermediate-high risk PE.
Key point: At 90 days, CAVT plus anticoagulation improved six-minute walk distance and raised the share of patients reaching NYHA class I versus anticoagulation alone; safety rates were reported as comparable.
Implication: May influence prescriber choice and payer reviews pending full data.

❤️ JenaValve launches Trilogy commercially in the US [3] [US • 13 Apr 2026]

https://cardiovascularnews.com/trilogy-valve-gets-us-commercial-launch/ Context: Launch follows FDA premarket approval for symptomatic severe aortic regurgitation in patients at high or greater risk for surgical aortic valve replacement.
Key point: JenaValve reported first US commercial Trilogy cases and positioned the device as the first US transcatheter therapy with a dedicated indication for high-risk aortic regurgitation.
Implication: May influence prescriber choice and payer reviews pending full data.

🩺 KingstronBio records first confirmatory-study use of ProStyle M [4] [China • 13 Apr 2026]

https://cardiovascularnews.com/prostyle-m-mitral-valve-system-gets-first-use-in-clinical-study/
Context: First implant was performed at Zhongshan Hospital, Fudan University, under pure ultrasound guidance; prior first-in-man experience covered 10 patients over two years.
Key point: KingstronBio completed the first implant of its ProStyle M transcatheter mitral valve system in the confirmatory national multicentre clinical study.
Implication: May influence prescriber choice and payer reviews pending full data.

💓 Screening-detected AF linked to substantial heart failure burden [5] [EU • 14 Apr 2026]

https://cardiovascularnews.com/heart-failure-found-to-be-common-in-people-with-af-detected-during-screening/
Context: Post-hoc analysis from Swedish STROKESTOP and STROKESTOP II, with median follow-up of 6.9 and 5.1 years, respectively.
Key point: Patients with screening-detected atrial fibrillation had about a threefold higher heart failure risk than those without AF, with heart failure often diagnosed within six months of AF detection.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

💊 Bayer wins UK approval for Kerendia in HF with LVEF ≥40% [6] [UK • 13 Apr 2026]

https://pharmatimes.com/news/bayer-wins-mhra-approval-for-kerendia-in-heart-failure/
Context: MHRA decision is based on the Phase 3 FINEARTS-HF study in 6,001 adults with symptomatic heart failure and ejection fraction of at least 40%.
Key point: Bayer’s Kerendia (finerenone) is now approved in the UK for adults with symptomatic chronic heart failure and LVEF ≥40%, including HFmrEF and HFpEF.
Implication: Regulatory change may affect treatment pathways and formulary discussions.

⌚ Smartwatch-derived pVO₂ may help flag HF worsening [7] [10 Apr 2026]

https://www.clinicaltrialsarena.com/analyst-comment/smartwatches-monitoring-heart-failure-exacerbations/?cf-view
Context: Reporting cites the Canadian TRUE-HF cohort, n=217, with Apple Watch-based monitoring over a scheduled 90-day period.
Key point: A Nature Medicine study summary suggests smartwatch measurements tracked cardiopulmonary fitness closely and that declines in estimated pVO₂ were associated with higher risk of unplanned healthcare use.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫀 FDA clears pivotal TRICURE US study for TriCares Topaz TTVR [8] [US • 09 Apr 2026]

https://citoday.com/news/fda-approves-tricure-us-pivotal-trial-of-tricares-topaz-ttvr-system
Context: IDE approval supports a pivotal trial in severe or greater tricuspid regurgitation at increased surgical risk, across up to 75 sites in the US, Canada, and Europe.
Key point: FDA approved the investigational device exemption for TriCares’ Topaz transcatheter tricuspid valve replacement system, enabling the TRICURE US pivotal study.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Structural heart innovation remains active across aortic, mitral, and tricuspid disease, with multiple pivotal or confirmatory studies moving forward [1][4][8].
Pulmonary embolism intervention is shifting toward recovery-focused endpoints, not only early reperfusion metrics [2].
Aortic regurgitation now has a dedicated US commercial transcatheter option for high-risk patients, which could reshape referral patterns [3].
Heart failure remains a cross-cutting theme, spanning AF screening, drug approvals, and remote monitoring tools [5][6][7].
Regulators and clinicians appear to be rewarding platforms that address undertreated populations and support less-invasive care pathways [3][6][8].

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FAQ

What is the STAR trial studying for MiRus Siegel?

STAR is a prospective, multicentre, randomised controlled trial comparing the Siegel 8Fr transcatheter heart valve with commercially available THVs in severe symptomatic aortic stenosis. Planned enrolment is 1,025 US patients, with a one-year composite primary endpoint of mortality, stroke, and cardiovascular hospitalisation [1].

What did STORM-PE add beyond earlier PE data?

The reported 90-day update focused on functional recovery. Patients treated with Penumbra Lightning Flash CAVT plus anticoagulation walked farther and more often reached NYHA class I than those on anticoagulation alone, while safety was reported as comparable [2].

Why is JenaValve Trilogy notable in the US market?

JenaValve says Trilogy is the first US transcatheter device with a dedicated indication for high-risk symptomatic severe aortic regurgitation. The company has now moved from FDA approval to first commercial implants [3].

What do the STROKESTOP findings mean for screening-detected AF?

The analysis suggests screening-detected AF is not benign. Heart failure risk was materially higher than in people without AF, and heart failure often appeared early after AF detection, within six months in the reported studies [5].

What changed for Bayer’s Kerendia in the UK?

The MHRA approved finerenone for adults with symptomatic chronic heart failure and LVEF ≥40%, covering HFmrEF and HFpEF. The decision was based on FINEARTS-HF, which Pharmatimes reported as a Phase 3 trial in 6,001 adults [6].

How strong is the smartwatch heart failure monitoring signal?

The report points to an observational monitoring study in TRUE-HF, not a treatment trial. It suggests wearable-derived pVO₂ estimates tracked reference testing well and may help identify patients at risk of worsening, but implementation will depend on validation and workflow fit [7].

Entities / Keywords

MiRus, Siegel, Siegel 8Fr, STAR trial, transcatheter aortic valve implantation, TAVI, transcatheter heart valve, THV, aortic stenosis
Penumbra, Lightning Flash, STORM-PE, computer-assisted vacuum thrombectomy, CAVT, pulmonary embolism, PE, NYHA, six-minute walk test
JenaValve Technology, Trilogy, ALIGN-AR, aortic regurgitation, AR, FDA PMA, commercial launch
KingstronBio Technology, ProStyle M, transcatheter mitral valve system, confirmatory clinical study, ultrasound guidance, Zhongshan Hospital, Fudan University
STROKESTOP, STROKESTOP II, atrial fibrillation, AF, heart failure, screening-detected AF, EHRA
Bayer, Kerendia, finerenone, MHRA, FINEARTS-HF, HFpEF, HFmrEF, LVEF
TRUE-HF, Apple Watch, smartwatch, pVO₂, cardiopulmonary fitness, remote monitoring, heart failure exacerbation
TriCares, Topaz, TTVR, TRICURE US, tricuspid regurgitation, TR, IDE approval, structural heart