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BSCI Quits TAVR, Major PE CV Acquisition, and Mayo + Corify
May 29, 2025
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Together with
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“This is reality; it’s not science fiction. We’re actually doing it. I’ve had patients of mine in the trial receive this one-and-done treatment, and it’s going to change the face of cholesterol management going forward.”
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Professor Riyaz Patel on the effectiveness of VERVE-102.
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Marking its departure from the TAVR market, Boston Scientific officially discontinued sales of its Acurate neo2 and Acurate Prime TAVR systems and will no longer seek approval from the FDA or other regulatory agencies.
- The Acurate valves were distinguished by a self-expanding stent frame with supra-annular leaflets and an Active PVseal skirt to minimize paravalvular leak.
- However, Boston Scientific’s TAVR systems faced steep competition from device incumbents like Medtronic and Edwards Lifesciences.
- The Acurate Prime TAVR valve gained CE mark approval in 2024, but FDA approval never came, effectively widening the gap between Boston Scientific and its competitors.
While there’s no one reason to blame for Boston’s decision, it’s likely the recent three way clinical comparison trial presented at TCT 2024 was part of it, as the Aucrate neo2 failed to meet the noninferiority margin compared to Medtronic’s Evolut and Edward’s Sapien platforms.
- During the study, patients treated with the Boston Scientific valves ultimately faced worse outcomes than patients treated with the Medtronic and Edwards valves.
- Researchers also noted that approximately 20% of the Acurate neo2 valves were not fully expanded, which may have been due to a lack of training rather than design error.
Whatever the reason behind the decision, Boston’s departure from the TAVR race underscores the complexity and difficulty around breaking into this market.
- For example, Medtronic’s valves are more widely used in Europe, while Edwards’ valves dominate in the U.S., with both cases a byproduct of which valve hit the market first.
The Takeaway
For Boston’s Acurate valves, getting to the party so much later than Sapien (which has established infrastructure and reputation among interventionalists), meant the devices needed to be significantly better or significantly cheaper to earn their place. Unfortunately the data didn’t seem to support this, leading Boston Scientific to bow out.
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GE HealthCare Unlocks Real-Time Cardiac Insights, Anywhere, Anytime
Your workstation isn’t the only place to view cardiac images. Tune in to this online webinar on how GE HealthCare’s Zero Footprint Viewer is being used in real clinical settings to access images anywhere, anytime.
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Monebo’s Approach to Cardiac Health Monitoring
The heart works day and night, so your cardiac monitoring software should too. Learn about how Monebo’s latest innovation superimposes long-term monitoring results onto a 24-hour circadian cycle scale, creating a comprehensive map of circadian variations.
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Relieving The Burden of Post-Processing
With the advent of advanced imaging technologies like CCTA come added burdens to technologists and diagnostic imaging centers. See how PIA can relieve the burden of post-processing, saving you time while helping your bottom line.
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- Corify Partners with Mayo: Corify Care entered into a know-how agreement with Mayo Clinic to help accelerate the development of its AI-driven technology for treating arrhythmias. Corify’s proprietary technology detects, maps, and manages arrhythmias by creating three-dimensional images of the heart’s electrical activity, supporting targeted ablation. As part of the partnership, Mayo Clinic physicians will help Corify refine its current AI model and make recommendations on improvements relating to useability and clinical flow.
- A Second Look at SEQUOIA-HCM: A new analysis of Cytokinetics’ SEQUOIA-HCM trial suggests that aficamten’s secondary effects vary slightly based on obstructive HCM symptom severity.
- While patients in the mild or moderate-to-severe HCM symptom groups had similar pVO2 and KCCQ-CSS improvements, the moderate-to-severe symptom group experienced greater improvements due to a lower baseline score. By the end of treatment, 54% of patients with mild symptoms and 36% of patients with moderate-to-severe symptoms were asymptomatic.
- CVL Acquires CCP: PE-backed Cardiovascular Logistics acquired Cardiology Consultants of Philadelphia to gain access to its network of 90 cardiologists across more than 30 locations throughout Southeastern Pennsylvania. The acquisition will allow CVL to leverage its management platform to help CCP scale its operations and support its continued growth. The acquisition gives CVL its first presence in Pennsylvania, and joins its other owned practices in the Southern U.S. and Upstate New York.
- Philips Launches Intracardiac Echo Catheter: Philips launched its VeriSight Pro 3D intracardiac echocardiography catheter in Europe, used to guide procedures like TAVR and LAAC. The company’s ICE catheter is 3mm in diameter and provides 3D echo imaging inside the heart, helping physicians make better clinical decisions during structural heart and EP interventions. The catheter works with Philips’ EPIQ ultrasound scanners and offers an alternative to transesophageal echocardiography, which often requires general anesthesia and extended room time.
- Infarctions on a Plane! Cardiology made mainstream news last week when a cardiologist used an AliveCor KardiaMobile portable 12-lead ECG to determine whether a man was having a heart attack aboard a flight to Amsterdam. The episode occurred after the passenger said his chest pain was 10/10, prompting the cardiologist to monitor him with the KardiaMobile and ultimately give him five different heart attack medications. Upon landing, the passenger was examined at a hospital and was not diagnosed with MI, stroke, or PE.
- CAC-Based Calculator Predicts Heart Risk: Adding coronary artery calcium scores to the AHA’s PREVENT clinical risk score better predicted future heart attack risk. In a study of 7k patients, researchers found that CCTA-derived CAC scores correlated well with PREVENT scores over an average follow-up period of 1.2 years. Patients who scored highly on either scale had greater heart attack risk, but adding CAC to PREVENT improved their predictive power even further.
- J&J’s SOUNDSTAR CRYSTAL: Johnson & Johnson MedTech launched its SOUNDSTAR CRYSTAL Ultrasound Catheter in the U.S. for intracardiac echocardiography imaging during ablation. The device provides enhanced anatomical image quality using an 88-element phased linear array and integrates with J&J’s CARTO 3 Mapping System for AI-powered ablation workflows. This allows providers to use a zero fluoroscopy workflow, which enhances ablation effectiveness and safety.
- AFib AI in BP Monitors: Bringing AFib detection to home BP monitoring, OMRON Healthcare announced that several of its consumer blood pressure monitors will integrate the company’s FDA-authorized, AI-powered AFib detection software known as IntelliSense. The IntelliSense AFib algorithm automatically checks for AFib during every blood pressure measurement and can provide early detection for high stroke and heart failure risk by incorporating over 300 mathematical indices to analyze the Pressure Pulse Wave generated as the blood pressure monitor cuff inflates.
- IVL Before PCI: Reinforcing the benefits of intravascular lithotripsy, Shockwave Medical unveiled the primary endpoint results of its EMPOWER CAD study examining PCI in women with calcified coronary artery disease. Researchers followed 399 female patients who received Shockwave IVL before their PCI and found that 86.9% were free from in-hospital target lesion failure after 30 days. Cardiac death and ischemia-driven target lesion revascularization rates were each 1.3% while procedural complications were rare (0.2%).
- Abbott’s TMVR System: The FDA approved Abbott’s Tendyne transcatheter mitral valve replacement system for treating mitral valve disease. The Tendyne system replaces mitral valves that are malfunctioning from calcium buildup in the base of the valves and offers a new treatment option for patients who are not candidates for open-heart surgery or mitral repair. The self-expanding valve is delivered through a small incision in the chest and is fully repositionable and retrievable during implantation.
- Rocket’s Clinical Hold: Rocket Pharmaceuticals is officially stuck on the launchpad following a clinical hold from the FDA for its RP-A501 gene therapy that treats Danon disease, a condition that weakens heart muscle. The clinical hold follows an unexpected serious adverse event during the Phase 2 clinical trial for RP-A501 that caused one patient to experience capillary leak syndrome and ultimately die. Rocket is conducting a comprehensive root cause analysis and is actively discussing its options with the FDA.
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Circle CVI’s Cardiac CT Expansion
Watch this Cardiac Wire interview with Circle Cardiovascular Imaging’s Chief Product Officer, Scott Galbari as he sheds light on Circle CVI’s history with cardiac MRI and how the company is tackling the coming demand for cardiac CT.
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Vista AI Grows CMR Volume
Are your patients waiting weeks or months for cardiac MRIs? See Brigham and Women’s Hospital’s real-world results showing how Vista AI’s software for automated MRI scanning led to 50% more scan slots, without adding more scanners or staff.
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A Better Way to Coordinate Post-Stroke Care
Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.
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- The CardioMEMS HF System is Now Covered by Medicare Advantage: Download reimbursement resources and view more information about the expanded coverage for your heart failure patients if coverage criteria is met.
- Making Cardiovascular Data Work for You: Today, cloud-native analytics can automate data acquisition and synthesize complex data. Discover what Optum’s technology can do to facilitate future advancements in cardiovascular data and analytics.
- Redefining Percutaneous Coronary Intervention: Learn about the AGENT™ Drug-Coated Balloon from Boston Scientific and how this technology is expanding the treatment options for patients with in-stent restenosis in the U.S. Rx only. (Sponsored by Boston Scientific)
- Streamline Your Cardiology Imaging Workflows: See how cardiologists and their teams can streamline imaging workflows to make their cardiovascular service line more efficient, cost-effective, and patient-centered, using Merge’s cardiology solutions.
- Experience the future of learning: Medtronic Academy 2.0 is here! Unlock your ultimate destination for structural heart medical education with the newly redesigned Medtronic Academy 2.0. Gain access to expert-led courses, webinars, and a wealth of resources to stay ahead in cardiovascular care. Visit now!
- Us2.ai and Fujifilm Automate CVUS: Fujifilm Healthcare Americas and Us2.ai have partnered to equip the LISENDO 880 cardiovascular ultrasound system with an AI-driven clinical workflow solution. Read more about how Us2.ai fully automates the LISENDO 880’s echocardiogram analysis and reporting.
- Heartflow Plaque Analysis: Accurate CAD Assessment Now Covered Across the US: Heartflow’s Plaque Analysis is now reimbursable thanks to Medicare’s new coverage for AI-enabled plaque analysis of eligible patients with coronary artery disease.
- Explore Vitrea Advanced Visualization: Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow
- Identify and Treat Cardiovascular Disease: Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.
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