Mounir Basalus, MD, PhD

Surgeries & Interventions

Abbott Enters Burgeoning IVL Segment

Intravascular lithotripsy (IVL) may have once been synonymous with Shockwave Medical, but it’s now rapidly becoming one of the hottest segments in interventional cardiology, spurred on by Abbott’s new IVL Investigational Device Exemption (IDE) from the FDA.

• IVL is a minimally invasive medical catheter-based procedure that treats calcified plaque in blood vessels. 
• IVL works by inflating a balloon inside the calcified blood vessel and generating shock waves to fracture the calcium, which is then removed for improved blood flow.
• Shockwave Medical was the first company to develop and commercialize IVL, applying it to PAD in 2016 and gaining calcified coronary artery approval in 2021. 

Abbott’s new IVL IDE was two years in the making following its $890M acquisition of Cardiovascular Systems in 2023 that gave the medtech giant an entry into the IVL arena. 

• With the FDA nod, Abbott can now evaluate the IVL system in treating severe calcification in coronary arteries prior to stenting. 
• For its first CAD trial – TECTONIC – Abbott plans to enroll up to 335 patients at 47 U.S. sites.

But the incumbent competition is already serious, as Shockwave was recently acquired by Johnson & Johnson for $13B and now has the medtech titan’s financial backing to accelerate marketing and commercialization.

• Following the trend, Boston Scientific acquired IVL developer Bolt Medical for $443M upfront this past January in an attempt to bolster its trajectory to market.

That’s a huge amount of money being thrown at IVL, which speaks volumes to the industry’s faith in its potential for removing calcified plaque – but it’s not just a technology for the big leagues…

• Smaller competitors like FastWave Medical ($31M in total funding), Vantis Vascular ($49M), and Amplitude Vascular ($67.3M) are still trying to make waves in the IVL segment too.
• Notably, FastWave’s FIH trial was successful last year, while Amplitude’s Pulse IVL system secured its IDE approval in June of 2024.

The Takeaway

Shockwave might have a decade head start, but it appears that the cardio-medtech industry has woken up to the potential of IVL, and this much competition is likely to breed innovation that benefits patients.

Plaque Analysis Now Covered by Medicare

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.

Cloud-Based Enterprise Imaging Empowerment

Do your cardiology imaging workflows follow cloud best practices? Read Optum and Frost & Sullivan’s enterprise imaging whitepaper to help you ensure your team is optimally housing, accessing, analyzing, and leveraging imaging data as the industry shifts to value-based care.

Offer Hope Not Just Inotrope to Your Patients with Advanced Heart Failure

Left ventricular assist devices (LVADs) have received Level 1A Recommendation from the AHA/ACC/HFSA guidelines.

The Wire

• Kerendia’s HFmrEF/HFpEF sNDA: Bayer announced that the FDA accepted its supplemental new drug application and granted Priority Review designation to KERENDIA (finerenone) for the treatment of adult patients with HFmrEF and HFpEF. The regulatory decision stems from the positive results of the Phase 3 FINEARTS-HF trial, in which finerenone significantly reduced a composite of CV death and total HF events by 16% in patients with HFmrEF/HFpEF. 

• Vasorum’s FDA Approval: Adding a new contender to the vascular catheter segment, the FDA approved Vasorum USA’s Celt ACD PLUS System for rapid arterial puncture closure. The new Celt ACD PLUS uses Vasorum’s Blood Signal technology to provide physicians with a visual indicator for precise placement and closure when ultrasound imaging isn’t an option. These features help reduce vascular closure complications like bleeding, hematomas, and pseudoaneurysms, leading to improved efficiency and cost savings.

• Heartflow’s Fresh Funds: Heartflow announced the closure of an additional investment round through $98M worth of convertible notes bringing the company to $890M in total funding. The fresh financing will support Heartflow’s research and development efforts for its coronary computed tomography angiography (CCTA)+Heartflow pathway for non-invasive CAD diagnosis and management.

• Viz HCM Shines in Four Studies: Viz.ai announced clinical data from four different studies demonstrating how its Viz HCM module enables better detection of hypertrophic cardiomyopathy. All four studies will be presented at ACC.25 and include how: (1) Viz HCM achieved a high degree of accuracy in detecting HCM, (2) identified HCM patients from an ECG up to five years early, (3) successfully integrated into clinical workflows, and (4) established a sensitivity of 56%, specificity of 100%, and PPV of 100%.

• Abiomed and Getinge Back At It: Nearly a decade since final judgment, the U.S. Court of Appeals for the Federal Circuit revived the patent infringement case between Getinge’s Maquet and Johnson & Johnson’s Abiomed. Back in 2016, Abiomed sued Getinge’s Maquet for a judgment of non-infringement on several of its patents. The appeals court originally decided that the district court erred in its interpretation of one of the patents, rejecting the infringement, however that could change with this new look.

• Low SBP for the Elderly: Is lower systolic BP always better for hypertensive patients aged 80 and over? When it comes to CVD mortality, the answer seems to be yes. Researchers examined NHANES data from 1988-2014 and found that patients with treated SBP <130 mmHg had a 26% lower risk of CVD mortality compared to patients with SBP of 130 to 160 mmHg. While the results support current BP management guidelines, the study’s authors believe future RCTs are needed to confirm the benefits.

• Ionis & Sobi’s Licensing: Ionis Pharmaceuticals entered into a license agreement under which Sobi receives exclusive rights in countries outside the U.S., Canada, and China to commercialize olezarsen as a potential treatment for familial chylomicronemia syndrome (FCS) and severely elevated triglycerides. Olezarsen is currently under review by the European Medicines Agency with a potential approval anticipated for the treatment of FCS this year. Ionis will continue to independently commercialize olezarsen in the U.S.

• Earlier is Better With Vutrisiran: Following vutrisiran’s (Alynlam’s Amvuttra) FDA approval for treating ATTR-CM, a new HELIOS-B sub-study suggests the drug’s benefits are greatest earlier in the disease’s progression. Researchers divided the sub-study’s 659 patients by NYHA class and found that the lower the disease severity, the better vitrusiran was at preventing recurrent CV events leading to respective hazard ratios of 0.54, 0.77, and 0.68 in classes I, II, and III. Although unsurprising, the results underscore the importance of early detection. 

• Plozasiran For Lowering TRL-P: Arrowhead Pharmaceuticals’ plozasiran could help lower cardiovascular risk by lowering TRL-P without raising small LDL-P, which is a common problem for intensive triglyceride-lowering therapies. As part of a JACC study, 403 patients from the SHASTA-2 (severe hypertriglyceridemia) and MUIR (mixed hyperlipidemia) trials were given either plozasiran or placebo, with those on the drug showing a ~50% reduction in TRL-P with no increase in apoB and potentially beneficial changes in large (+53%), medium (+56%), and small LDL-P (-13%).

• Kardigan Acquires Prolaio: CV drug developer Kardigan acquired cardiology data company Prolaio in an effort to expand its CV data collection and analytics abilities. The acquisition allows Kardigan to integrate Prolaio’s software and high-density patient data to optimize and accelerate its CVD R&D pipeline. Kardigan’s decision to acquire Prolaio comes after its platform was validated with five FDA-cleared algorithms, more than four million hours of patient data, and 20+ issued patents.

• DurAVR One-Year Results: Anteris Technologies announced promising one-year results for patients treated with its balloon-expandable DurAVR Transcatheter Heart Valve System. So far, 65 patients have received the DurAVR with no valve or cardiovascular related mortality and no prosthesis-patient mismatch. The one-year data will be included in the planned IDE submission to the FDA for conducting the DurAVR THV RCT.

Cardiology AI: From Research to Clinical Practice

Explore how AI algorithms are reshaping cardiology with insights from Tempus’ recent webinar, featuring Dr. David Ouyang of UCLA and Cedars-Sinai, alongside Tempus’ Dr. John Pfeifer and Dr. Brandon Fornwalt. This expert panel dives into how AI can bridge diagnostic gaps, enhance patient outcomes, and streamline workflows for conditions like AFib and pulmonary hypertension. Read the full recap to glimpse the future of AI-driven cardiology.

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

Connecting the ECG Monitoring Ecosystem

There’s so much that goes into building the solutions that providers use each week, and that’s definitely true for ECG monitoring. In this Cardiac Wire Show interview with Flipside Media’s president Brad Ummer, we get an insider’s view of what it takes to develop an ECG monitoring solution, including Flipside’s partnership with Monebo Technologies.

The Resource Wire

• AI-Echo for Cardiac Amyloidosis: Despite advancements in cardiac imaging, cardiac amyloidosis remains significantly underrecognized and underdiagnosed. Discover how Us2.ai’s deep learning diagnostic algorithm uses echocardiography and apical 4-chamber DICOM images to detect CA.

• Uncover Cleerly’s Clinical Success: Interested in learning more about the science behind Cleerly’s suite of medical technologies that are revolutionizing cardiac imaging? Read here for all of Cleerly’s recently published clinical studies. 

• 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!

• Vista.ai’s Cardiac MRI Case Studies: It’s easy to claim AI improves Cardiac MRI workflows, but it’s a lot harder to back those claims up. Tune in to these discussions with imaging experts to see how Vista Cardiac lives up to its promise of faster, more consistent, and reliable CMR scans.

• Discover Innovation in Intervention: Explore how the AGENT™ Drug-Coated Balloon from Boston Scientific is advancing U.S.-based treatment options for patients with coronary artery disease. Rx Only. (Sponsored by Boston Scientific)

• Configure Your PCI Study: See for yourself how cardiac imagers use GE HealthCare’s Centricity Cardio Enterprise Universal Viewer to do their PCI studies, including configurable viewport setup and side-by-side comparisons.

• 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.

• Assessing CAD with Circle CVI: Did you know that Circle CVI offers a suite of cardiac CT tools for the assessment of coronary artery disease? See how Circle combines heart function segmentation, automated plaque analysis, CAC scoring, reporting, and viewing in a single dedicated Cardiac CT package.

• Merge Still Best in KLAS: Merge Cardio and Merge Hemo continued their KLAS hot streak, ranking Best in KLAS 2025 for Cardiology and Hemodynamics for the 10th and 13th years. Discover the user enhancements and software improvements that led to Merge Cardio and Merge Hemo’s latest wins. 

• 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.

The Industry Wire

1. Kansas reports measles outbreak with 23 cases.
2. Nearly 3M HIV deaths due to foreign aid cuts.
3. Michigander dies from donated kidney tainted with rabies.
4. Penn Medicine to acquire Doylestown Health on April 1.
5. Senators seek to lower Medicaid cuts in GOP tax plan.
6. RFK Jr. plans to cut 10k HHS employees.
7. Medicaid, SNAP cuts could lead to 1M job losses.
8. DOJ backs up providers in suit against Claritev.
9. J&J boosts US manufacturing as big pharma reshores.
10. Drug-resistant Candida auris spreads in hospitals.