Cardiac electrophysiology

Abbott and Stereotaxis Technologies Used in First Integrated Procedures in the United States

Retrieved on: 
Tuesday, October 31, 2023

ST. LOUIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the first patients in the United States have been treated successfully utilizing Abbott’s EnSite™ X EP System integrated with Stereotaxis’ Robotic Magnetic Navigation System.

Key Points: 
  • ST. LOUIS, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced the first patients in the United States have been treated successfully utilizing Abbott’s EnSite™ X EP System integrated with Stereotaxis’ Robotic Magnetic Navigation System.
  • The integration of Abbott’s leading cardiac mapping system and Stereotaxis’ advanced robotic technology, first announced at Heart Rhythm 2023, combines highly detailed real-time diagnostic information with the unprecedented precision and stability of robotics during therapy delivery.
  • The first integrated procedures in the US were completed by physicians at Weill Cornell Medical Center, Mount Sinai Morningside, Banner University Medical Center Phoenix, and Overland Park Regional Medical Center.
  • “The combined benefits of advanced mapping and robotic technologies allows us to envision a new era of cardiac care where personalized therapy is designed and delivered to each individual patient.

Positive results from first-in-human completely leadless CRT in the US, published in The Journal of the American College of Cardiology

Retrieved on: 
Wednesday, October 25, 2023

The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.

Key Points: 
  • The positive results published in JACC are based on a 1-year follow-up of the first-in-human implantation in the US of totally leadless CRT pacing utilizing the Micra™ leadless pacing system in the right ventricle in conjunction with EBR's investigational WiSE® CRT Electrode in the left ventricle of the heart.
  • This first use in the US of the WiSE CRT System as a first-line therapy is a future market expansion opportunity for EBR.
  • "It's great to see these positive results being published in a world-leading cardiology journal, such as The Journal of the American College of Cardiology," said John McCutcheon, President & CEO of EBR Systems.
  • "This case study highlights the potential of totally leadless CRT for patients struggling with traditional CRT, but also beyond these patient groups, the 64 million heart failure patients across the globe."

Icahn School of Medicine at Mount Sinai Awarded $10.2 Million NIH Grant to Explore the Early Signs of Arrhythmic Mitral Valve Prolapse

Retrieved on: 
Tuesday, September 26, 2023

NEW YORK, Sept. 26, 2023 /PRNewswire-PRWeb/ -- Researchers at the Icahn School of Medicine at Mount Sinai have been awarded a $10.2 million grant from the National Heart, Lung and Blood Institute of the National Institutes of Health to investigate risk factors for malignant arrhythmias in mitral valve prolapse. This work aims to develop a better understanding of the condition and novel solutions to improve patient outcomes.

Key Points: 
  • The grant is a collaboration between four Icahn Mount Sinai specialties: Cardiac Electrophysiology, Cardiology, Cardiovascular Surgery, and the BioMedical Engineering and Imaging Institute (BMEII).
  • The grant is a collaboration between four Icahn Mount Sinai specialties: Cardiac Electrophysiology, Cardiology, Cardiovascular Surgery, and the BioMedical Engineering and Imaging Institute (BMEII).
  • In the United States, it is estimated that between 7 and 9 million people have mitral valve prolapse, the most common form of valve disease.
  • Mitral valve prolapse occurs when two flaps within the mitral valve don't close smoothly or evenly, but instead bulge (prolapse) upward into the left atrium when the heart contracts.

Study Finds Significant Reduction in Esophageal Injury Rate When Using ensoETM™ During Cardiac Radiofrequency Ablation Procedures

Retrieved on: 
Monday, September 25, 2023

Esophageal injury can occur during ablation procedures for the treatment of atrial fibrillation, and an AEF is the most severe form of injury, resulting in death in most cases.

Key Points: 
  • Esophageal injury can occur during ablation procedures for the treatment of atrial fibrillation, and an AEF is the most severe form of injury, resulting in death in most cases.
  • View the full release here: https://www.businesswire.com/news/home/20230925491005/en/
    A peer-reviewed study in the Journal of the American College of Cardiology: Clinical Electrophysiology (JACC-EP) has found a significant reduction in the rate of atrioesophageal fistulas (AEFs) during cardiac ablation of the left atrium when using Attune Medical’s ensoETM proactive esophageal cooling device compared to luminal esophageal temperature monitoring.
  • The authors concluded that adoption of active esophageal cooling during RF ablation of the left atrium for the treatment of atrial fibrillation was associated with a significant reduction in AEF rate.
  • “This is the first study of the effectiveness of any technique to show a significant benefit in the reduction of AEFs.

HeartSciences Signs Definitive Agreements with the Icahn School of Medicine at Mount Sinai to Commercialize Artificial Intelligence Cardiovascular Algorithms

Retrieved on: 
Thursday, September 21, 2023

HeartSciences has entered into licenses covering rights to a variety of Icahn Mount Sinai’s AI algorithms, technologies and patent filings for the screening and diagnosis of cardiovascular disease.

Key Points: 
  • HeartSciences has entered into licenses covering rights to a variety of Icahn Mount Sinai’s AI algorithms, technologies and patent filings for the screening and diagnosis of cardiovascular disease.
  • HeartSciences and Icahn Mount Sinai have also entered into a memorandum of understanding for ongoing cooperation encompassing de-identified data access, on-going research, and the evaluation of HeartSciences’ MyoVista® wavECGTM.
  • Mount Sinai and Mount Sinai faculty, including Dr. Nadkarni; Dr. Vaid; Joshua Lampert, MD, Medical Director of Machine Learning for Mount Sinai Heart; Vivek Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and Mount Sinai Health System, and The Leona M. and Harry B. Helmsley Charitable Trust Professor of Medicine in Cardiac Electrophysiology at Icahn Mount Sinai; and Son Duong, MD, Assistant Professor of Pediatrics (Pediatric Cardiology) at Icahn Mount Sinai, have a financial interest in this technology and in HeartSciences.
  • The financial interest of Mount Sinai faculty is pursuant to the Mount Sinai Intellectual Property Policy.

Orchestra BioMed Granted FDA Approval of IDE to Initiate BACKBEAT Pivotal Study of BackBeat CNT™ for the Treatment of Hypertension in Pacemaker Patients

Retrieved on: 
Tuesday, September 19, 2023

Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.

Key Points: 
  • Orchestra BioMed and Medtronic plc (NYSE: MDT) formed a strategic collaboration for the development and commercialization of AVIM therapy for hypertensive pacemaker patients in July 2022.
  • Under the collaboration, Medtronic is providing Orchestra BioMed with development, clinical, and regulatory support for the BACKBEAT global pivotal study, which Orchestra BioMed is sponsoring.
  • Orchestra BioMed will share in the revenues generated from Medtronic sales of the AVIM-enabled pacing systems.
  • “We are thrilled to receive IDE approval from the FDA and move forward with plans to initiate the BACKBEAT global pivotal study, which is designed to support potential future regulatory review and potential approval of AVIM therapy for hypertensive patients indicated for a pacemaker.

Cardiovascular Organizations Pursue New, Independent Medical Board

Retrieved on: 
Thursday, September 21, 2023

WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine. The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists. Collectively, the American College of Cardiology (ACC), Heart Failure Society of America (HFSA), Heart Rhythm Society (HRS) and Society for Cardiovascular Angiography & Interventions (SCAI) are working together to submit a new Board application, with potential for additional consortium members to join.

Key Points: 
  • WASHINGTON, Sept. 21, 2023 /PRNewswire/ -- Many of the nation's most prominent cardiovascular organizations, representing tens of thousands of physicians, unite today to pursue the creation of a new Board for cardiovascular medicine.
  • The proposed new Board would be independent of the American Board of Internal Medicine, where the cardiology certification process currently exists.
  • "We know that the cardiovascular community is ready for an independent, self-governed entity, and we are proud to develop this new Board with cardiologists and cardiology organizations at the helm."
  • Together, the consortium will submit an application to the American Board of Medical Specialties (ABMS), requesting an independent medical Board for cardiovascular medicine to pursue a new competency-based approach to continuous certification—one that harnesses the knowledge, skills and attitudes required to sustain professional excellence and care for cardiovascular patients effectively.

Attune Medical’s ensoETM™ Granted FDA De Novo Marketing Authorization to Reduce the Likelihood of Ablation-related Esophageal Injury Resulting from Radiofrequency Cardiac Ablation Procedures

Retrieved on: 
Thursday, September 14, 2023

Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.

Key Points: 
  • Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
  • View the full release here: https://www.businesswire.com/news/home/20230914650329/en/
    Attune Medical has been granted De Novo marketing authorization from the US Food and Drug Administration (FDA) for its ensoETM device to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures.
  • It is the most common type of cardiac ablation procedure, with over 300,000 per year performed in the US alone.
  • This De Novo marketing authorization expands the ensoETM’s indications for use to reduce the likelihood of esophageal injury resulting from radiofrequency cardiac ablation procedures.

RhythmScience Announces Formation of Medical Advisory Board

Retrieved on: 
Thursday, August 31, 2023

SAN FRANCISCO, Aug. 31, 2023 /PRNewswire/ -- RhythmScience, a leader in cardiac data management and services, today announced the formation of its Medical Advisory Board (MAB).

Key Points: 
  • SAN FRANCISCO, Aug. 31, 2023 /PRNewswire/ -- RhythmScience, a leader in cardiac data management and services, today announced the formation of its Medical Advisory Board (MAB).
  • "We selected MAB members across a range of cardiology expertise, and we are excited to work with this esteemed group."
  • said Shawn Kumar, CEO of RhythmScience.
  • With their collective knowledge and expertise, we are confident in our ability to positively impact the future of cardiac care."

MEDICARDIA HEALTH INC. INCORPORATES WEARABLE ECG INTO ADVANCED REMOTE PATIENT MONITORING PLATFORM FOR ATRIAL FIBRILLATION SCREENING

Retrieved on: 
Wednesday, August 23, 2023

MILWAUKEE, Aug. 23, 2023 /PRNewswire/ -- MediCardia Health announced the integration of wearable ECG from FDA registered consumer devices for use in remote monitoring of patients with and at risk for developing atrial fibrillation (AF).

Key Points: 
  • MILWAUKEE, Aug. 23, 2023 /PRNewswire/ -- MediCardia Health announced the integration of wearable ECG from FDA registered consumer devices for use in remote monitoring of patients with and at risk for developing atrial fibrillation (AF).
  • The advance marks an important milestone for the company in streamlining care of people with atrial fibrillation through remote monitoring and virtual care.
  • "Atrial fibrillation is the most common heart rhythm disorder, affecting more than 40 million people around the world.
  • Atrial fibrillation increases the risk of stroke five-fold and these strokes are often fatal or disabling, particularly because 25-40% of patients are not even aware they are in AF.