|
Magenta’s MCS Disruption | REVIVED CAD Evidence
July 25, 2024
|
|
|
|
|
Together with
|
|
|
|
“Imagine that.”
|
|
Keck-USC’s David Brown, MD after yet another study showed that complete revascularization does not improve chronic CAD outcomes.
|
|
|
Surgeries & Interventions
|
|
|
|
|
|
Israeli heart pump startup Magenta Medical wrapped up a $105M financing round to advance clinical programs supporting its Elevate left ventricular assist device, a percutaneous heart pump that Magenta believes could disrupt the mechanical circulatory support (MCS) segment.
The miniature Elevate device is folded and delivered percutaneously through the femoral artery (8 Fr inner diameter, 10 Fr sheath), passing through the aorta and aortic valve, before self-expanding in patients’ hearts where it controls blood flow (surpassing 5 L/min of mean flow, 8L/min peak).
- Elevate would become the world’s smallest heart pump, and the most powerful transcatheter pump, even smaller/stronger than Abiomed’s Impella (9 Fr, 4-6 L/min flow).
- More importantly, it could make the Elevate pump applicable to all MCS conditions, eliminating the need for device escalations and unnecessary/invasive surgical replacements.
That potential has helped Magenta raise over $200M across five rounds so far, including a $55M round in May 2023, which have funded the Elevate pump’s mounting clinical evidence:
The new funding will now support Magenta’s U.S. clinical programs across a range of MCS indications, and its efforts to seek FDA approval for patients undergoing high-risk PCIs (with other indications likely coming after).
You can see why Magenta and its VC investors are bullish, considering the device’s smallest/strongest credentials, the heart pump market’s projected growth, Magenta’s co-founders’ track record (their previous heart valve startup sold to Medtronic for $350M), and Abiomed’s massive $16.6B acquisition by J&J.
- Even Abiomed, who most view as Magenta’s primary heart pump competitor, was an early investor in Magenta Medical back in 2017.
The Takeaway
Although Magenta Medical still has a lot to prove, and its path towards commercial adoption is unlikely to be straightforward, the Elevate pump’s potential to disrupt the MCS market makes this small and mighty device worth keeping an eye on.
|
|
|
Monebo’s AF ECG Algorithm
Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.
|
|
How to Identify and Treat More CVD Patients
Do you know how many patients with high CVD risks are in your chest CT archive? See how the Stanford Health Care System used Bunkerhill Health’s Incidental CAC algorithm to screen its previous non-gated chest CTs, identify patients with coronary calcium, and get them on statins.
|
|
- REVIVED Evidence Against Complete CAD Revascularization: The REVIVED-BCIS2 trial added even more evidence that complete revascularization does not improve outcomes in chronic CAD patients, even though the practice remains widespread. Among 670 randomized patients with severe LV dysfunction and multivessel CAD, patients who received complete anatomical or viability-guided revascularization had no different likelihood of either death or HF hospitalization (HRs: 0.90 & 0.95).
- Wegovy’s UK CVD Approval: Less than four months after Novo Nordisk’s semaglutide (Wegovy) gained FDA approval for cardiovascular event risk reduction, the blockbuster GLP-1 has landed a similar approval in the UK. The UK approval was driven by Wegovy’s SELECT trial, which slashed patients’ major cardiac event risks by 20% over five years. With the UK’s 7.6M citizens living with CVD, this approval could significantly expand Wegovy’s already massive demand.
- Aficamten’s nHCM Effectiveness: A study from the FOREST-HCM trial found that aficamten is safe and effective for non-obstructive hypertrophic cardiomyopathy (nHCM) over 36 weeks. Among 34 patients, 82.3% reached a 15-20 mg dose, with a modest LVEF reduction of 4.3% (p < 0.0001). At 36 weeks, 79.4% saw an NYHA class improvement, and quality of life scores improved by 13.8 points, while no patients discontinued aficamten due to adverse events.
- Volta & GE’s EP AI Alliance: Volta Medical’s interoperability strategy took a big step this week, following the electrophysiology AI startup’s joint development agreement with GE HealthCare. Volta will integrate its Volta AF-Xplorer solution for AI-based dispersed electrogram assessments with GE’s Prucka 3 and CardioLab EP Recording system, with the goal of streamlining AFib ablation guidance workflows.
- Worse TR with TV-ICDs: Compared to subcutaneous implantable cardioverter-defibrillators (S-ICDs), transvenous ICDs (TV-ICDs) appear to significantly increase tricuspid regurgitation risks. A JACC study found far higher rates of TR in TV-ICD patients after six months (42% vs. 19%), while moderate or severe TR was present in far more TV-ICD patients (7% vs. 2%), and the odds of worsening TR were 7.2 times higher with TV-ICDs. However, there were no differences in right ventricular size or function.
- AFib Smart Ring: AFib detection has become a primary health feature in smart watches, and it’s apparently making its way to smart rings. Wearable maker Ultrahuman announced that its Ring Air device has added AFib detection through a monthly subscription. The new AFib detection feature is powered by FibriCheck’s PPG technology (FDA and CE approved), which measures heart rhythm by applying a light source to the skin and then uses AI to measure changes in blood volume and detect arrhythmias.
- Us2.ai’s LV Evidence: A new Frontiers study further supported echo AI’s potential, finding that Us2.ai’s AI solution measured LV volume and function as well as human readers, and outperformed the 3D Heart Model. Among 109 patients, Us2.ai’s LV volume measurements were strongly correlated with the human operators (r = 0.89 for LVEDV, r = 0.92 for LVESV), producing higher correlations than between the two human readers themselves (r = 0.74 and r = 0.84) and the 3D Heart Model
- Restore Medical’s HFrEF Breakthrough: Restore Medical’s ContraBand transcatheter Pulmonary Artery Banding (PAB) system landed FDA Breakthrough Device Designation, potentially streamlining the HFrEF treatment’s path towards approval. The ContraBand device is specifically intended for HFrEF patients who remain symptomatic despite maximally tolerated GDMT, and has shown in initial studies to improve LV volume, hemodynamic function, and physical capacity.
- OCT’s Mixed PCI Advantage: A new substudy from the ILUMIEN IV trial comparing OCT with angiography for PCI guidance mirrors overall results released in August 2023, finding that OCT’s list of advantages doesn’t include target vessel failure. In a subset of 1,973 patients with complex lesions, the final minimal stent area was larger with OCT (5.56 mm vs. 5.26 mm), and OCT’s MACE risk was lower (3.1% vs. 4.9%), but target vessel failure rates were similar (7.3% vs. 8.8%).
- Prior Auth Damages: According to the American Medical Association’s annual prior authorization survey, 78% of doctors think issues with prior authorization result in patients forgoing care. The survey of 1,000 physicians showed that 94% believe prior auths “always, often, or sometimes” delayed a patient’s access to necessary care, and 19% reported that those delays have resulted in patients being hospitalized. Prior auths have been in the hot seat over the last few weeks, with multiple other studies turning up the heat.
|
|
Enterprise Imaging and the Evolution of Connected Care
Enterprise imaging is the foundation of connected and ultimately human care, in cardiology and beyond. Check out this GE HealthCare report to uncover the next steps in your enterprise imaging journey, and what that means for your patients and physicians.
|
|
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!
|
|
Planning Your Move to The Cloud
There’s a long list of advantages to transitioning your enterprise imaging to the cloud, but you have to plan that move first. This Optum e-book details what health IT and imaging leaders need to know before moving their enterprise medical imaging to the cloud.
|
|
- A Solution for Your Entire Cardiology Service Line: The pace of change in healthcare can be dizzying, creating new and more complex challenges for cardiology departments to overcome. See how Merge Cardio and Merge Hemo can turn those challenges into opportunities for greater workflow efficiency and improved care.
- Explore the Potential of Cardio AI: Explore the potential of AI-powered cardiology solutions in this on-demand TeraRecon webinar, detailing how its Cardio Suite solutions help expedite disease diagnosis, care coordination, and provide the data to support cardiac treatment decisions.
- 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.
- 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.
- HeartFlow Evidence: With 500+ peer-reviewed publications, HeartFlow has shown its commitment to clinical research, and validated its potential to transform the diagnosis and management of coronary artery disease worldwide.
- 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.
- AI-Driven Novice Heart Failure Screening: We hear a lot about AI’s potential to expand echocardiography to far more users and clinical settings, and a study using Us2.ai’s AI-automated echo analysis and reporting solution showed that echo AI might make novice-led heart failure screening possible.
|
|
|
|
|
