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Stryker Enters IVL, A Valve Institute, and AI-CCTA Lawsuit April 16, 2026
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Together with
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“Hospitals are putting hard caps on physician compensation, sometimes as low as the 75th percentile, and calling it fraud and abuse protection. Think about what that means. If earning above the 90th percentile is inherently suspicious, then 10 percent of every physician in every specialty must be breaking the law.”
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Kevin Pho, MD.
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Intravascular lithotripsy is becoming a game of giants after Stryker’s announcement that it will acquire Amplitude Vascular Systems (AVS) for an undisclosed amount to add the company’s IVL system to its peripheral vascular portfolio.
- AVS was founded in 2017 and developed the Pulse IVL platform, which delivers high-frequency pressure waves at a rate of approximately 15 per second.
- This allows the device to break through peripheral plaques without the use of an emitter since the pulses travel across the entire balloon, though it still needs FDA approval.
This acquisition may be unique in its PAD scope, since other IVL acquisitions tend to revolve around CAD or CAD+PAD, but it’s still the fourth IVL acquisition in the last three years…
- First, Abbott acquired Cardiovascular Systems in 2023 for $890M.
- Then Johnson & Johnson acquired industry incumbent Shockwave Medical for $13.1B.
- After which Boston Scientific acquired BOLT for $664M (It previously held a 26% stake).
That’s a lot of money being thrown at the still incredibly young peripheral and coronary artery IVL market. For reference, Shockwave made around $1.75B across its entire IVL portfolio last year.
- We don’t know how much Stryker paid for AVS, but can guess it’s probably closer to what BSCI and Abbott paid rather than J&J’s immense investment.
- Stryker also already shelled out $4.9B for Inari Medical in 2025 to bolster its vascular intervention offerings in pulmonary embolism and venous thrombectomy.
These IVL acquisitions also signal a bigger trend in interventional cardiology, one which reminds us that the medtech titans like to invest in technologies that fit within a workflow they already own.
- This means Stryker could market this new IVL platform alongside its existing peripheral offerings which would keep clinical workflows within the same product ecosystem.
- And a cath-lab reputation of quality and consistency could help Stryker market its IVL platform more easily among those already accustomed to its other interventional tech.
The Takeaway
There’s no doubt the medtech world thinks IVL is a frontier-style gold rush, and Stryker’s latest acquisition is an example of that. It’s also another sign that each medtech player wants to offer its own version of a product as part of a broader ecosystem.
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Book a Time with AccurKardia at HRS 26
The AccurKardia team is heading to Chicago from April 23-26, and will be exhibiting their FDA-cleared AccurECG 2.0 platform. Book a time here to find out about AccurECG’s device-agnostic, vendor neutral, and enterprise-volume ready design.
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Heart Failure Hospitalization Doubles Risk of Cardiovascular Death
21% of patients with symptomatic heart failure escalate to hospitalization for heart failure or cardiovascular death, and 25% of those who experience hospitalization are readmitted due to heart failure within one year of discharge. Watch Bayer’s Dr. Alanna Morris-Simon discuss heart failure hospitalizations and when to assess care plans.
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The Power of AI in Cardiovascular Imaging
Cardiac labs are under more pressure than ever to deliver more with greater speed and precision. Hear from Tony Gallagher, Director of Noninvasive Cardiology at Baptist Health Lexington about how Siemens Healthineers’ ACUSON Origin is reshaping daily practice and transforming the future of echocardiography.
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- Etiometry’s Cardiogenic Shock Tool: Etiometry gained FDA clearance for the world’s first automated solution that classifies and tracks cardiogenic shock using real-time physiologic data. The tool was designed in alignment with SCAI staging guidelines and integrates EHR data to provide continuous surveillance across ICUs and step-down units. Etiometry claims this will help address the current 50% gap in undocumented shock cases while potentially reducing ICU readmissions and length of stay through improved situational awareness.
- Reflow Medical Spur Stent’s Long-Term Success: One year data from the DEEPER REVEAL trial found that Reflow Medical’s Spur Peripheral Retrievable Stent System achieved 78% primary patency in patients with chronic limb-threatening ischemia (CLTI). The retrievable scaffold uses expandable spikes to modify complex below-the-knee vessels before being fully removed, yielding an 83.1% freedom from target lesion revascularization. These outcomes highlight a significant improvement in wound healing and Rutherford classification compared to historical balloon angioplasty results.
- FDA Expands Alert on Medline Syringes: The FDA issued a safety update regarding Medline’s Class I-recalled NAMIC angiographic syringes, which are currently distributed within AVID Medical’s surgical convenience kits. Linked to four serious injuries, the devices pose a risk of disconnection during contrast administration. Regulators now mandate prominent warning labels for Cardiac Cath and Neuro IR packs, instructing providers to discard the syringes or exercise extreme caution if no other clinical alternatives are available.
- FDA Flags Cook Medical: The FDA also issued an early alert warning against the use of certain Cook Medical Centimeter, Aurous, and Beacon Tip sizing catheters due to risks of cracking and breakage. While no injuries have been linked to the issue, the agency cautioned that device fragmentation during vascular interventions could cause vessel injury or life-threatening complications. Cook Medical has halted sales and requested the return of all affected lots while the investigation continues.
- Mount Sinai Launches Adams Valve Institute: Mount Sinai Health System debuted the Adams Valve Institute, a global hub dedicated to advancing reconstructive surgical techniques and education for complex heart valve disease. The institute will establish specialized “centers of excellence” for high-risk procedures, including the Ross procedure and complex reoperations. The launch addresses growing “brain drain” concerns in cardiac surgery by gathering intricate cases as transcatheter interventions increasingly dominate valve replacement procedures.
- No Benefit for HFNOT: Results from the NOTACS trial show that high-flow nasal oxygen therapy (HFNOT) after cardiac surgery doesn’t improve clinical outcomes compared to standard oxygen. In a study of 1.2k patients, HFNOT demonstrated no significant impact on days alive and at home intubation, mortality, or reintubation rates. Researchers concluded that routine prophylactic implementation is unsupported, as preoperative comorbidities exert a far greater influence on recovery than the choice of post-extubation respiratory device.
- CTO PCI Superior for Symptom Relief: A combined analysis of the EUROCTO and DECISION-CTO trials demonstrated that PCI for chronic total occlusions significantly improves quality of life and reduces angina compared to medical therapy alone. By isolating 518 patients with single-vessel disease, researchers eliminated confounding factors from prior studies, reporting significantly higher SAQ scores and a 92.2% cumulative success rate. The findings reinforce recent sham-controlled data, supporting a stronger case for revascularization in symptomatic patients managed by high-volume operators.
- IMPACTS-BP Drives Blood Pressure Control in Low-Income Patients: The IMPACTS-BP trial revealed that a systematic, team-based intervention achieved a 6.4 mmHg greater reduction in systolic blood pressure compared to usual care among low-income populations. Utilizing health coaching and home monitoring across 36 health centers, the multifaceted strategy helped nearly 48% of participants reach targets below 130 mmHg. These findings underscore the feasibility of scaling intensive SPRINT-style management within resource-constrained primary care settings.
- AccurKardia + Specialized Medical: AccurKardia announced a multi-year partnership with Specialized Medical to integrate its FDA-cleared AccurECG 2.0 analytics engine into Wellysis’ S-Patch Monitoring System. Currently active in over 20 clinics across four states, the collaboration processes live-streaming data for mobile cardiac telemetry and Holter testing. By combining hardware connectivity with automated interpretation, the platform streamlines clinical workflows and expands access to enterprise-grade cardiac intelligence in underserved and rural communities.
- Etripamil’s Safety Results: A Phase 3 analysis of etripamil (CARDAMYST), the first self-administered treatment for PSVT, confirmed that the drug is safe following its December 2025 FDA approval. Researchers found that drug-induced mean SBP changes remained below 2 mmHg after dosing, with hypotension and syncope occurring very rarely (0.4% and 0.2% respectively). This news came shortly before CARDAMYST became available via Express Scripts, one of the nation’s largest pharmacy benefit managers. Milestone is now working on the RESET-PSVT Registry to generate evidence on the treatment’s long-term efficacy.
- Heartflow Sues Cleerly for Patent Infringement: Heartflow filed a lawsuit against rival Cleerly, alleging that the company infringed on six patents related to AI-powered CCTA software. The filing alleges that Cleerly’s CEO and a former president both had prior access to Heartflow’s proprietary technology through earlier partnerships. Heartflow is seeking a jury trial and damages for lost profits. Cleerly responded to the lawsuit with a statement that asserts: “ We are confident in our extensive and well-established intellectual property portfolio and the originality of our technology.”
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CA Diagnosis Using Echo AI
Diagnosing cardiac amyloidosis using echo can be challenging due to the imaging overlap between CA and more prevalent causes of cardiomyopathy. Read more about how Us2.ai’s echocardiographic score and fully automated deep-learning model overcome this challenge to enable better diagnosis.
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cvi42’s Real World Results
Consistency of measurements over time is of utmost importance for clinical interpretation and follow-up. Read about how cardiac imagers are using Circle Cardiovascular Imaging’s cvi42 platform to dramatically reduce manual segmentation by up to 60%.
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The Benefits of Outsourced Post-Processing
Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.
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- 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.
- Merge & Us2.ai for Accessible Cardiac AI: AI isn’t the future anymore, it’s an irreplaceable feature for cardiac imaging. Dive deeper into how Merge & Us2.ai are integrating FDA-cleared algorithms with advanced imaging systems to help clinicians focus on what matters most – their patients.
- The Nature of Raw ECG Signals: Raw ECG recordings are inherently affected by noise, motion artifacts, and variability in signal acquisition. Read more about how Monebo has focused on transforming raw cardiac signals into reliable, clinically meaningful insight for over two decades.
- A Cardiovascular Ultrasound Platform You Can Trust: Being able to provide premium diagnostic information for your pediatric patients every day, all day, is vital. Find out why cardiac imagers trust Fujifilm’s Lisendo 880, and how its premium imaging quality, efficiency tools, and reliability you can trust, have helped change workflows for clinicians and technologists alike.
- 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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