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Edwards Acquisition Spree | Wegovy’s EU Expansion
July 29, 2024
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Together with
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“These things take decades.”
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W. Ben Utly on why cardiology’s gender pay gap won’t be narrowing in the coming years.
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Edwards Lifesciences is going all-in on structural heart and heart failure, acquiring aortic valve-maker JenaValve Technology and implantable heart failure monitor company Endotronix for $1.2B and up to $445M in milestone payments.
These two acquisitions could impact Edwards’ structural heart and heart failure portfolios in unique and meaningful ways…
JenaValve’s Trilogy TAVR system doesn’t yet have FDA approval, but is CE Marked for both aortic regurgitation and aortic stenosis, which is notable given that all other TAVR systems only address aortic stenosis.
- The JenaValve Trilogy could gain FDA approval for aortic regurgitation by late 2025, complementing Edwards’ already strong aortic stenosis capabilities.
Endotronix recently landed FDA approval for its Cordella heart failure sensor, which combines an implanted PA sensor to measure congestion, a handheld PA pressure reader, and a digital health platform to enable comprehensive home-based HF management.
- The Cordella system could have a major impact, given the success of its PROACTIVE-HF trial, and its anticipated nationwide coverage by CMS in early 2025.
These acquisitions also confirm that Edwards is in the middle of an M&A spree, as they come just a few weeks after it acquired early-stage TMVR company Innovalve Bio Medical for $300M and invested $16M in surgical mitral valve startup Affluent Medical.
In fact, Edwards likely has more M&A coming up, noting that it just sold its Critical Care business to BD for $4.2B, pledging to use the influx of capital to “to fund strategic growth investments” targeting structural heart, pulmonology, and interventional heart failure technologies.
Although these recent acquisitions aren’t expected to have a major impact on Edwards’ finances until at least 2026, their success is crucial in the long term, noting that Edwards just reported a slowdown in its flagship TAVR business that sent the stock plummeting 31%.
The Takeaway
Edwards made it clear that it was going to use its Critical Care cash to drive strategic growth, and it hasn’t taken long to put that plan into action, acquiring its way into key growth areas for the company and the overall cardiac device segment.
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HeartFlow Uncensored
Dr. Drew’s Health Uncensored did a deep dive on the challenges with traditional heart disease testing and the importance of early diagnoses, while highlighting how HeartFlow’s breakthrough non-invasive tech provides patients clarity and confidence in understanding their heart health.
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- Wegovy’s EU CVD Approval: Four months after Novo Nordisk’s semaglutide (Wegovy) gained FDA approval for cardiovascular event risk reduction and just two days after landing CVD approval in the UK, the blockbuster GLP-1 has now gained a similar CVD approval by EU regulators. The approvals were driven by Wegovy’s SELECT trial, which slashed patients’ major cardiac event risks by 20% over five years. Given the UK and EU’s millions of citizens living with CVD, these approvals could significantly expand Wegovy’s already massive demand.
- SGLT-2is’ Independent Benefits: A meta-analysis of 12 trials reveals that SGLT2 inhibitors improve type 2 diabetes patients’ cardiovascular and kidney outcomes, regardless of the patients’ GLP-1 receptor agonist use. Among 73k patients, SGLT2 inhibitors reduced MACE by 10-19% and chronic kidney disease progression by 33-35%, suggesting that both SGLT-2is and GLP-1s are needed for better heart and kidney health.
- Kestra’s WCD Disruption Funding: Wearable cardioverter defibrillator startup Kestra Medical landed a massive $196M round to fast-track its commercial expansion and “disrupt the existing $1 billion WCD market.” Kestra’s ECG-based ASSURE cardiac recovery system supports cardiac monitoring and defibrillation for ventricular arrhythmias, and uniquely records other clinically significant arrhythmias, with a design that better supports female patients. It’s already been prescribed to over 10k patients, although Kestra and its investors see plenty of room for growth.
- Ultrasound Score Predicts HF Outcomes: A small European study found that the Venous Excess Ultrasound Score protocol (VExUS), which depicts venous congestion in multiple organs, could help predict poor outcomes in emergency heart failure cases. In the prospective study of 50 ER patients with acute decompensated HF, 94% of patients who were readmitted to the ER (n=18) and 100% of the patients who died (n=6) had a VExUS score of 3 at the time of admission.
- Predicting Preeclampsia: UCLA researchers developed a panel of circulating extracellular vesicular microRNA signatures intended to detect preeclampsia early in pregnancy, before clinical symptoms. In a prospective study of 26 patients, the microRNA panel had an AUC of 0.96 for predicting development of preeclampsia early in gestation.
- Incentivizing Cardiac Rehab: Poorer patients are more likely to complete cardiac rehabilitation if they’re paid for it. Researchers randomized 192 lower socioeconomic status patients to four rehab adherence programs: usual care, support from an in-hospital case manager, financial incentives, or both a case manager and incentives. After one year, patients who had both a case manager and financial incentives, or patients who only received financial incentives were most likely to complete cardiac rehab (62% & 42%), far above patients who had a case manager or usual care (25% & 11%).
- FibriCheck Heads Stateside: Belgian AFib detection startup FibriCheck announced its U.S. expansion, following the FDA clearance of its patient-facing smartphone application, AI algorithm, and healthcare provider portal. FibriCheck takes a unique and potentially more accessible approach to AFib detection, applying a smartphone light to the skin to measure heart rhythm, and then using AI to measure changes in blood volume. They’ve also shown “ECG equivalence,” with previous studies revealing 98.3% sensitivity and 99.9% specificity for AFib detection.
- Evolut TAVR Outcomes Reassure: JACC published reassuring longer-term Medtronic TAVR outcomes data from the Evolut Low Risk TAVR Bicuspid Study. Among 150 low-risk bicuspid aortic stenosis patients treated with Medtronic’s Evolut valves, rates of all-cause mortality or disabling stroke were 1.3% at one year, 3.4% at two years, and 4.1% at three years, with no reported moderate/severe paravalvular aortic regurgitation. That said, the corresponding editorial maintained that more long-term data are needed and encouraged making TAVR eligibility decisions on a case-by-case basis.
- Cardiologists’ Imbalanced Wealth: A new Medscape report shows that 70% of cardiologists enjoy family net worths above $1M, with 20% at or above $5M (the 4th highest of any specialty). However, male cardiologists are far more likely to have higher family net worths than their female colleagues, especially at the $2-$5M (25% vs. 10%) and over-$5M ranges (16% vs. 6%), suggesting that structural wage gaps won’t see significant improvements in the coming years.
- AI Cuts Chest Pain Triage: Researchers in JAMA showed that ED chest pain patients receive faster care and quicker discharge when triaged with an AI algorithm. The researchers analyzed 12k ED visits before and after three hospital sites adopted Beckman Coulter’s TriageGO algorithm. After AI implementation, far more patients were assigned low acuity levels (23.1% vs. 6.4%), while length of stay was significantly reduced for hospitalized patients (657.5 to 502 min median), and time to emergency cardiovascular procedures was slashed by a significant 205 minutes.
- Unmasking Masked HTN: In a trial of 320 patients, antihypertensive treatment improved target organ damage in patients with masked hypertension. Patients who received antihypertensive therapy had a significant reduction in 24-hour blood pressure compared to those on placebo (−10.1/−6.4 mmHg vs. −1.3/−1.0 mmHg). The treatment group also had a higher rate of organ damage improvement, which included LV hypertrophy, albumin-creatinine ratio, and brachial-ankle pulse wave velocity (51.6% vs. 29.3%).
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The Post-Acute Stroke Game Changer
See how Viz Connect solution can optimize your post-acute stroke pathway. The Viz.ai solution allows the cardiology team to promptly receive Neurology referrals to evaluate patients with suspected AFib for cardiac monitoring and reduce their risk of secondary stroke.
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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!
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- The Post-Acute Stroke Game Changer: See how Viz.ai’s Viz Connect solution can optimize your post-acute stroke pathways, allowing the cardiology team to evaluate cryptogenic stroke patients right at their bedside, while leveraging AI detection and automated communications to increase disease awareness and facilitate referrals.
- 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.
- Join the Cardiovascular Revolution: See how Optum enterprise imaging can prepare you for the future of imaging with industry-leading structured reporting, single-database architecture, AI and cloud-native design.
- Precision QRS Detection: QRS detection is essential for any ECG algorithm, and Monebo’s Kinetic QRS ECG Algorithm sets the standard for accuracy. Kinetic QRS accurately detects the QRS complex, no matter the amplitude, waveform, or noise levels.
- Track Your Post-Treatment Plaque: Tune-in to this upcoming Cleerly webinar where preventative cardiologist John Osborne, MD, PhD, FACC, FNLA will explore how to use CTA to track plaque progression and identify residual risk post-treatment.
- Cardiology’s Path to Enterprise Imaging: By connecting healthcare teams through every image, every scan and every report, we can reveal the full picture of a patient’s story. Check out this GE HealthCare Cardiology Coffee Break and see how enterprise imaging seamlessly integrates with existing technology infrastructures, ensuring compatibility across systems and platforms, enhances workflow efficiency, and more.
- Incidental CAC Predicts Long-Term Risks: What if you could identify which of your asymptomatic patients have high risks of future cardiac events? Stanford-led researchers used Bunkerhill Health’s Incidental CAC algorithm to do just that, finding that patients with ≥100 incidental CAC scores had a 24% 10-year risk of developing ASCVD and far higher risks of major adverse events.
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