Cardiovascular Today—July 2, 2026

This week’s Cardiovascular update highlights regulatory progress, advancing clinical evidence, expanding structural heart programs, evolving imaging technologies, safety actions, and updated treatment guidance.

In Today’s Newsletter

Dive deeper

💓 Laplace TTVR pivotal trial gets FDA IDE [1] [US • 30 Jun 2026]

https://cardiovascularnews.com/triumph-trial-of-laplace-ttvr-system-gets-ide-approval/
Context: TRIUMPH is a prospective, multicentre pivotal study of the Laplace TTVR system in severe tricuspid regurgitation.
Key point: Laplace Interventional said the FDA approved an IDE for TRIUMPH, targeting about 400 randomised patients plus a registry of up to 150.
Implication: May influence prescriber choice and payer reviews pending full data.

🔍 Terumo Opuswave dual-view coronary imaging gets first US use [2] [US • 30 Jun 2026]

https://cardiovascularnews.com/terumos-dual-view-coronary-imaging-system-gets-first-us-use/
Context: Annapoorna S Kini performed the first US procedure on 15 Jun 2026 at Mount Sinai Fuster Heart Hospital in New York.
Key point: Terumo’s Opuswave system combines OFDI and IVUS in one DualView catheter for simultaneous coronary imaging.
Implication: May expand procedural imaging options and support real-time lesion and stent assessment.

🫀 Thubrikar Optimum TAVI CE mark trial expands with Mac’s Medical Group [3] [EU • 29 Jun 2026]

https://cardiovascularnews.com/investment-supports-expansion-of-ce-mark-trial-of-thubrikar-tavi-system/
Context: Mac’s Medical Group and affiliates will finance up to 50 implants in the Optimum TAVI CE mark trial.
Key point: Thubrikar Aortic Valve said the partnership supports expansion into Croatia, Serbia and other countries.
Implication: Signals pipeline investment and modality expansion.

📊 PARTNER 3 shows Sapien 3 TAVI durability comparable to surgery at seven years [4] [US • 26 Jun 2026]

https://cardiovascularnews.com/partner-3-trial-shows-tavi-holds-up-to-savr-at-seven-years-on-durability/
Context: PARTNER 3 randomised 1,000 low-risk severe aortic stenosis patients to Sapien 3 TAVI or SAVR.
Key point: Seven-year follow-up showed similar SVD, BVF and valve-related reintervention rates between TAVI and SAVR.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Sapien M3 TMVR registry signals promise in mitral annular calcification [5] [US/CA/NL/UK/AU • 30 Jun 2026]

https://cardiovascularnews.com/registry-data-hint-at-promise-for-tmvr-system-in-mac/
Context: ENCIRCLE MAC registry enrolled high-risk patients with MAC-related mitral valve dysfunction unsuitable for surgery or TEER.
Key point: Edwards Lifesciences Sapien M3 showed sustained MR reduction and functional gains through one year in selected patients.
Implication: May influence prescriber choice and payer reviews pending full data.

⚠️ Stryker InZone Detachment System recalled over battery issue [6] [US • 29 Jun 2026]

https://cardiovascularbusiness.com/topics/clinical/vascular-endovascular/neurovascular-device-recalled-due-safety-concerns
Context: The InZone Detachment System is used in neurovascular embolization and peripheral arterial and venous embolization procedures.
Key point: Stryker recalled nearly 45,000 devices due to potential premature battery drain, classified by FDA as a Class II recall.
Implication: Introduces operational risk management needs and may affect procedure planning.

💊 ACC updates antiplatelet evidence review for ASCVD management [7] [US • 30 Jun 2026]

https://cardiovascularbusiness.com/topics/clinical/pharmaceutics/acc-guidance-explores-antiplatelet-therapies-management-ascvd
Context: The 2026 ACC Scientific Statement reviews antiplatelet therapy for primary and secondary prevention and ASCVD management.
Key point: ACC highlighted shorter DAPT after PCI in selected ACS patients, followed by ticagrelor or prasugrel monotherapy.
Implication: Could inform practice and payer discussions; interpretation depends on study design and patient risk.

🤖 AI becomes embedded across cardiac imaging workflows [8] [US • 26 Jun 2026]

https://cardiovascularbusiness.com/topics/artificial-intelligence/ai-transforming-cardiac-imaging-often-ways-clinicians-do-not-recognize
Context: Cedars-Sinai imaging expert Damini Dey described AI use in acquisition, reconstruction, segmentation and plaque analysis.
Key point: AI is increasingly embedded in cardiac imaging systems, often without clinicians recognizing where it is operating.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

Why it matters

Structural heart pipelines remain active across tricuspid, aortic and mitral disease, with pivotal trials and registries shaping future evidence.
Long-term TAVI durability data remain central as younger and lower-risk patients are considered for transcatheter treatment.
Coronary imaging and cardiac AI tools are moving deeper into routine workflows, with clinician oversight still emphasized.
Safety and access decisions remain dynamic, from device recalls to revised antiplatelet evidence reviews.

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🧰 See our full range of services. Discover how we can help you.

🎯 Catch up on the Top Cardiovascular news from the past two weeks, curated by the LucidQuest team.

🎬 Watch on YouTube.

FAQ

What is TRIUMPH for Laplace TTVR?

TRIUMPH is a pivotal Laplace Interventional trial for severe tricuspid regurgitation. It is designed to assess safety and effectiveness, with randomised and registry cohorts. [1]

What makes Terumo Opuswave different?

Terumo Opuswave combines OFDI and IVUS in one DualView catheter. The company says this provides simultaneous depth and high-resolution surface imaging. [2]

What is being tested in the Thubrikar Optimum TAVI CE mark trial?

The trial is evaluating the investigational Optimum TAVI system. The supplied source says Mac’s Medical Group will help finance up to 50 implants as the trial expands in Europe. [3]

What did PARTNER 3 report about Sapien 3 at seven years?

PARTNER 3 reported similar rates of structural valve deterioration, bioprosthetic valve failure and valve-related reintervention for Sapien 3 TAVI and SAVR. [4]

What did the ENCIRCLE MAC registry show for Sapien M3?

The registry reported lower 30-day mortality than predicted by surgical risk and sustained MR reduction in selected MAC patients. It was single-arm registry evidence. [5]

Why was Stryker’s InZone Detachment System recalled?

The recall was linked to potential premature battery drain. FDA classified the issue as a Class II recall, according to the supplied source. [6]

Entities / Keywords

Laplace Interventional, Laplace TTVR system, TRIUMPH, severe tricuspid regurgitation, TTVR, TEER, FDA IDE
Terumo Interventional Systems, Opuswave, DualView catheter, OFDI, IVUS, coronary imaging
Thubrikar Aortic Valve, Optimum TAVI, Mac’s Medical Group, CE mark trial, TAVI
Edwards Lifesciences, Sapien 3, PARTNER 3, TAVI, SAVR, severe aortic stenosis, SVD, BVF
Edwards Lifesciences, Sapien M3, ENCIRCLE, TMVR, mitral annular calcification, MAC, mitral regurgitation
Stryker, InZone Detachment System, neurovascular embolization, Class II recall, premature battery drain
American College of Cardiology, ACC, ASCVD, DAPT, ticagrelor, prasugrel, aspirin, clopidogrel
Damini Dey, Cedars-Sinai, cardiac imaging AI, CCTA, AutoPlaque, CT-FFR, plaque analysis