Cardiovascular Today—December 10, 2025

This week’s cardiovascular update brings together new clinical evidence, device innovations, and regulatory milestones shaping the future of cardiac care. From emerging therapies and non-invasive technologies to advances in interventional tools and surgical systems, here are the key updates to watch.

In Today’s Newsletter

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❤️ Tirzepatide Heart Effects Do Not Vary by Heart Failure Status [1] [New Orleans • 2 Dec 2025]

https://x.com/CardiologyToday/status/1996520612076941704

Key point: Tirzepatide offers similar cardiovascular benefits as dulaglutide regardless of heart failure status, with superior outcomes for death/hospitalization in heart failure patients.

Context: SURPASS-CVOT trial, analyzing tirzepatide vs dulaglutide in 13,165 patients with type 2 diabetes and atherosclerotic cardiovascular disease.

Implication: Results may influence treatment choices in patients with both diabetes and heart failure, with potential for broader use of GLP-1s.

🧘 US FDA Clearance for Hotwire Transseptal Access System [2] [USA • 4 Dec 2025]

https://cardiovascularnews.com/us-fda-clearance-for-hotwire-transseptal-access-system/

Key point: Atraverse Medical receives FDA clearance for its Hotwire RF guidewire, designed to improve procedural control in left atrium access.

Context: The Hotwire system has been successfully used in nearly 2,000 procedures and is designed to mitigate risks of uncontrolled energy delivery.

Implication: Could significantly improve safety and efficiency in electrophysiology and structural heart interventions.

🫀 AltaValve Early Feasibility Study: Positive One-Year Results [3] [Greece • 4 Dec 2025]

https://cardiovascularnews.com/altavalve-early-feasibility-study-positive-one-year-results/

Key point: AltaValve shows positive one-year outcomes, including high technical success and elimination of mitral regurgitation in high-risk patients.

Context: Early feasibility study with a focus on transcatheter mitral valve replacement (TMVR) for patients with severe MR and challenging anatomy.

Implication: Promising results may influence future treatment options and patient selection for TMVR procedures.

💉 Non-Invasive Ultrasound Therapy for Aortic Stenosis Gains CE Mark [4] [France • 5 Dec 2025]

https://cardiovascularnews.com/non-invasive-ultrasound-therapy-for-aortic-stenosis-gains-ce-mark/

Key point: Cardiawave’s Valvosoft, a non-invasive ultrasound therapy for aortic stenosis, receives CE certification.

Context: The therapy uses high-intensity focused ultrasound to restore leaflet mobility in the aortic valve, improving symptoms in patients not suited for immediate valve replacement.

Implication: This innovative treatment offers an alternative for high-risk patients, potentially changing the management of aortic stenosis.

🧪 Game-Changing Stroke Trial Recruits 200th Patient [5] [UK • 6 Dec 2025]

https://www.sth.nhs.uk/news/2025/12/06/game-changing-stroke-trial-recruits-200th-patient/

Key point: The Triceps trial has recruited its 200th patient to test transcutaneous vagus nerve stimulation in improving arm and hand weakness in stroke survivors.

Context: Trial involves 19 NHS centers and could pave the way for a non-invasive rehabilitation treatment at scale.

Implication: If successful, this treatment could significantly impact stroke rehabilitation, especially for patients not eligible for surgery.

❄️ Tenecteplase Non-Inferior to Alteplase in Thrombolytic Success for Valve Thrombosis [6] [India • 9 Dec 2025]

https://cardiovascularnews.com/tenecteplase-non-inferior-to-alteplase-in-thrombolytic-success-for-valve-thrombosis/

Key point: Tenecteplase shows non-inferiority to alteplase in patients with mechanical heart valve thrombosis, with better thrombolytic success and shorter hospital stays.

Context: A randomized trial involving 83 patients with obstructive valve thrombosis compared the two thrombolytic agents.

Implication: Could offer a safer, more efficient alternative to alteplase, especially in younger patients with lower bleeding risks.

🤖 National Trial: Ketamine Raises Heart Risk, No Survival Advantage Over Etomidate in Emergency Intubation [7] [USA • 9 Dec 2025]

https://news.cuanschutz.edu/news-stories/national-trial-ketamine-raises-heart-risk-no-survival-advantage-over-etomidate-in-emergency-intubation

Key point: A large trial finds ketamine increases cardiovascular risks without improving survival compared to etomidate in emergency intubation.

Context: A multicenter randomized trial to provide definitive evidence on the safety and efficacy of ketamine vs. etomidate.

Implication: Findings could shift clinical practice toward etomidate for emergency intubation, particularly in patients with cardiovascular instability.

🔧 Premarket Notification Submitted to FDA for SSi Mantra Surgical Robotic System [8] [USA • 9 Dec 2025]

https://cardiovascularnews.com/premarket-notification-submitted-to-fda-for-ssi-mantra-surgical-robotic-system/

Key point: SS Innovations has submitted a 510(k) premarket notification for the SSi Mantra surgical robotic system, aiming to provide cost-effective, advanced surgical robotics.

Context: The system has been installed in 137 hospitals worldwide and has completed over 7,300 procedures.

Implication: If approved, this system could offer a more affordable option for hospitals, particularly in underserved areas, expanding access to robotic-assisted surgery.

Why It Matters

Tirzepatide’s heart benefits may broaden treatment options for patients with diabetes and heart failure, particularly in terms of reducing death and hospitalization rates.
Hotwire’s FDA clearance represents a significant step forward in improving procedural control and safety during complex heart interventions.
AltaValve’s success in a high-risk population may reshape the approach to mitral valve replacement in patients previously considered ineligible.
Valvosoft’s CE mark offers a non-invasive alternative for managing aortic stenosis, potentially eliminating the need for invasive valve replacement surgeries in certain patients.
Triceps stroke trial could lead to a revolutionary rehabilitation option for stroke survivors with hand and arm weakness.
Tenecteplase’s success in valve thrombosis could establish it as a preferred thrombolytic agent, especially in younger, lower-risk patients.
Ketamine vs Etomidate findings may guide future sedation choices in emergency care, especially in critically ill patients with cardiovascular risks.
SSi Mantra’s FDA submission highlights its potential to improve surgical outcomes with more cost-effective robotic systems, especially for underserved hospitals.

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FAQ

What is the key finding of the Triceps stroke trial?

The Triceps trial aims to test transcutaneous vagus nerve stimulation to improve arm and hand weakness in stroke survivors. It has reached a significant milestone by recruiting 200 patients, with the potential to offer a non-invasive treatment for those not eligible for surgery.

How does Tenecteplase compare to Alteplase in treating valve thrombosis?

Tenecteplase has been shown to be non-inferior to alteplase, with better thrombolytic success and a shorter hospital stay, making it a promising alternative for patients with mechanical heart valve thrombosis.

Why is the FDA submission for SSi Mantra significant?

SS Innovations’ SSi Mantra system offers a cost-effective robotic option for surgery, which could make robotic-assisted surgery more accessible, particularly in underserved hospitals.

Entities / Keywords

Tirzepatide, Hotwire, AltaValve, Valvosoft, Triceps, Tenecteplase, Ketamine, Etomidate, SSi Mantra, FDA, TAVI, stroke rehabilitation, heart valve treatment, robotic surgery.