ThinkMedTek

Happy 2024 Everyone!

Due to last week being a holiday week this week’s news post is shortened.

1. CVRx has received FDA approval for revised instructions for use for its Barostim neuromodulation system, incorporating long-term data from its BeAT-HF randomized clinical trial. The Barostim system delivers electrical pulses to baroreceptors in the carotid artery wall, activating the body’s baroreflex to restore balance to the autonomic nervous system and reduce heart failure symptoms.
2. Engineers at MIT have developed a robotic right ventricle replica that combines real heart tissue with synthetic balloon-like artificial muscles, enabling scientists to control the ventricle’s contractions and study natural valves and other structures. The robotic right ventricle could offer a realistic platform to study right ventricle disorders, test devices, and therapies, potentially leading to improved treatment strategies for patients with heart disease.
3. Microbot Medical has successfully completed its GLP pivotal preclinical surgical robot study using the Liberty endovascular surgical robotic system in a porcine model. The study involved 96 robotic navigations and, based on the data, Microbot aims to submit an FDA investigational device exemption (IDE) application to advance to human clinical trials, transitioning into a clinical-stage company.
4. Researchers at University College London (UCL) have developed an electrocardiographic imaging (ECGI) vest that could help predict the risk of sudden cardiac death. The reusable, time-efficient vest, which requires just five minutes per patient, features 256 sensors that can generate 3D digital models of the heart and its electrical activity, providing valuable information for risk stratification and personalized treatment.
5. Boston Scientific has initiated the Avant Guard clinical trial to assess the safety and efficacy of its Farapulse Pulsed Field Ablation (PFA) system as a first-line treatment for persistent atrial fibrillation (AF). The study will compare the outcomes of ablation with Farapulse against anti-arrhythmic drug therapy, involving over 500 patients, and aims to contribute to the competitive landscape in the PFA market in 2024.

Sources

1. https://www.massdevice.com/fda-approves-expanded-label-cvrx-neuromod/ 
2. https://www.medicaldesignandoutsourcing.com/engineers-say-robot-mimics-heartbeats-blood-pumping/ 
3. https://www.massdevice.com/microbot-medical-preclinical-surgical-robot-study/ 
4. https://www.medicaldesignandoutsourcing.com/ecg-imaging-vest-predict-cardiac-risk/
5. https://www.mddionline.com/regulatory-quality/boston-sci-initiate-new-farapulse-trial-move-up-anticipated-fda-approval-date