Heart Rhythm

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

Retrieved on: 
Tuesday, October 31, 2023
Associate, NYSE, Cardiac electrophysiology, Overland Park Regional Medical Center, Robotics, Physician, Icahn School of Medicine at Mount Sinai, Electrophysiology, Arrhythmia, Banner - University Medical Center Phoenix, Weill Cornell Medical Center, Heart Rhythm, Workflow, Patient, Diagnosis, Medical device, Stereotaxis, Medicine

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.

Implicity CEO Selected to Participate in HRX 2023 Panel Discussion on AI & Remote Cardiac Monitoring

Retrieved on: 
Monday, September 18, 2023
Cleveland Clinic, HRS, HRX, PDT, Research, Medicine, Doctor of Philosophy, Ren Ci Hospital, Heart Rhythm, Digital health, MD, Patient, Machine learning, Mortality, AI, RPM, Cleveland, Medical device, Implications of U.S. gene patent invalidation on Australia

CAMBRIDGE, Mass, Sept. 18, 2023 /PRNewswire/ -- Implicity, a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced today that co-founder and CEO Arnaud Rosier, MD, PhD, has been selected to participate in a panel discussion at the upcoming HRX 2023 Digital Health Event in Seattle, WA. The discussion, AI-aided Remote Interventions - Will this Transform Healthcare Delivery & Outcomes, takes place September 22, 2023, at 2:30 pm (PDT).

Key Points: 
  • CAMBRIDGE, Mass, Sept. 18, 2023 /PRNewswire/ -- Implicity , a leader in remote patient monitoring (RPM) and cardiac data management solutions, announced today that co-founder and CEO Arnaud Rosier, MD, PhD, has been selected to participate in a panel discussion at the upcoming HRX 2023 Digital Health Event in Seattle, WA.
  • The discussion, AI-aided Remote Interventions - Will this Transform Healthcare Delivery & Outcomes , takes place September 22, 2023, at 2:30 pm (PDT).
  • As part of the discussion, Dr. Rosier intends to share insights on new international recommendations for remote monitoring of cardiovascular implantable devices (CIED) released at Heart Rhythm 2023 (HRS) .
  • "We recently published groundbreaking data that demonstrated our AI-powered cardiac remote monitoring technology saves lives and significantly improves health outcomes," said Dr. Rosier, electrophysiologist, CEO, and co-founder of Implicity.

Aziyo Biologics Announces Publication of a CanGaroo® Case Study Demonstrating Bioenvelope Benefits for Reoperative Procedures

Retrieved on: 
Wednesday, August 30, 2023
Fibrosis, ICD, Rehabilitation, CIS, HEAL, Physician, Heart Rhythm, Patient, Calcification, Biopsy, Medical device

SILVER SPRING, Md., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Aziyo Biologics, Inc. (Nasdaq: AZYO) (“Aziyo”), a company that develops and commercializes biologic products to improve compatibility between medical devices and the patients who need them, today announced the publication of a case report highlighting results that demonstrate the potential benefits of using a biological device envelope during reoperative procedures for CIEDs.

Key Points: 
  • The report, titled “ Rehabilitation of an Existing Device Implant Pocket Using a Biologic Extracellular Matrix Envelope ,” was published in the peer-reviewed journal Heart Rhythm Case Reports.
  • This case study builds upon interim results from the HEAL Study indicating that CanGaroo can significantly reduce fibrous lead entrapment and decrease procedural difficulty when used during initial device implantation.
  • “This case study builds upon the interim HEAL Study data presented earlier this year at Heart Rhythm 2023,” said Dr. Michelle LeRoux Williams, Chief Scientific Officer of Aziyo.
  • The findings in this case study are consistent with previously reported data published in Circulation demonstrating that CanGaroo prevents foreign body reactions within the host, reducing hypovascular fibrous capsule development.

Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System

Retrieved on: 
Tuesday, August 8, 2023
Heart, Freedom, Pulmonary vein stenosis, Boston Scientific, BSX, Anatomy, CE marking, Medicines and Healthcare products Regulatory Agency, Food and Drug Administration, FACC, Clinical trial, Cryoablation, Cryotherapy, Banner University Medical Center Tucson, Heart Rhythm, Patient, Freezing, Physician, PMDA, AF, FDA, NYSE, Food, Safety, Medical imaging, Medical device, FHRS, MD, Electrophysiology

MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.

Key Points: 
  • First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems
    MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System.
  • "The U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific.
  • The POLARx Cryoablation System received CE Mark in February of 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October of 2021.
  • The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.

Stereotaxis and Abbott Combine Technologies in First Integrated Procedures to Treat Arrhythmia Patients

Retrieved on: 
Tuesday, July 18, 2023
Workflow, Erasmus MC, Heart Rhythm, Patient, Physician, Electrophysiology, Arrhythmia, Robotics, NYSE, Safety, Medical imaging, Medical device, Stereotaxis

The combination of Abbott’s leading cardiac mapping system with Stereotaxis’ advanced robotic technology brings together highly detailed real-time diagnostic information with the unprecedented precision and stability of robotics during therapy delivery.

Key Points: 
  • The combination of Abbott’s leading cardiac mapping system with Stereotaxis’ advanced robotic technology brings together highly detailed real-time diagnostic information with the unprecedented precision and stability of robotics during therapy delivery.
  • The integration of these technologies was announced at Heart Rhythm 2023.
  • “The integration of both systems enables me to address the most complex arrhythmia patients.
  • I am very pleased with this technological advance and the growing recognition that robotics plays an important role for the electrophysiology field.”

BIOTRONIK Demonstrates Ongoing Commitment to Advancing Scientific Knowledge at HRS

Retrieved on: 
Friday, June 23, 2023
Insurance, Database, Arrhythmia, Mayo Clinic, Di Biase, Heart failure, Vaccination, Effect, Wildfire, COVID-19, ATP, ICD, Stanford University, Research, History, VF, Physical, Medicare, US, Heart Rhythm, Ventricular tachycardia, Patient, Physician, DX, Stanford University School of Medicine, Albert Einstein College of Medicine, Air pollution, Pharmaceutical industry, S81

LAKE OSWEGO, Ore., June 23, 2023 /PRNewswire/ -- Continuing a history of commitment to furthering research in its field, four studies supported by BIOTRONIK's real-world evidence generating research initiative, CERTITUDE, were presented at Heart Rhythm 2023 on May 20th and 21st.

Key Points: 
  • The CERTITUDE registry, established in 2020, is a comprehensive source of real-world data gathered from BIOTRONIK Home Monitoring®, device tracking, and insurance claims data from qualifying US BIOTRONIK patients.
  • This data is made available for physicians to leverage through submission and approval of a research proposal.
  • Results from two other CERTITUDE analyses highlighted BIOTRONIK products, features and their corresponding benefits for patients and clinicians.
  • Leveraging a natural experiment to determine the effect of air pollution on ventricular arrhythmias and physical activity: The 2020 U.S. wildfires.

Element Science Announces Completion of Enrollment in the Jewel IDE Study Evaluating the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)

Retrieved on: 
Tuesday, May 23, 2023
Research, Wearables, Mobile Technology, Mobile, Wireless, Technology, Medical Devices, Clinical Trials, Health Technology, Cardiology, Health, Science, Exercise, Arrest, Overalls, Fear, Dick's Picks Volume 20, Sale, SCA, MHS, Heart Rhythm, Patient, Physician, Risk, Principal, Caregiver, Safety, Jewel, Nursing, Medical device, MD

Element Science , an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients transitioning from hospital to home, announced the completion of enrollment in its Jewel IDE Study (NCT05201495).

Key Points: 
  • Element Science , an innovative health technology company pioneering a digital wearable platform for high-risk cardiovascular patients transitioning from hospital to home, announced the completion of enrollment in its Jewel IDE Study (NCT05201495).
  • Data from the study will be submitted for U.S. regulatory approval of the Jewel P-WCD to protect patients at temporary elevated risk of sudden cardiac arrest (SCA).
  • “We are grateful to the study participants and clinical research professionals for their commitment and contributions to the Jewel IDE Study.
  • A patient case from the Jewel IDE Study presented at Heart Rhythm 2023 demonstrated the benefits of the Jewel P-WCD and Mobile App.

egnite, Inc. Announces Research from Its Real-World Database at Heart Rhythm 2023

Retrieved on: 
Sunday, May 21, 2023
Technology, Research, Medical Devices, Cardiology, Software, Practice Management, Health, Data Management, Science, Heart failure, Survival, Heart, GDMT, Heart Rhythm, MD, Patient, Pharmaceutical industry, Medical device

“Over the last five years, new therapies to treat heart failure emerged with promising improvements in survival benefit. This study represents the first time we’ve seen an assessment of ‘5-class’ guideline-directed therapy -- up to 4 foundational medication classes plus ICD/CRT-D therapy -- for these patients,” said John Mignone, MD, Ph.D., Robert M. and Patricia Arnold Endowed Medical Director for Heart Failure and Co-Executive Medical Director, Swedish Heart and Vascular Institute. “The next big challenge to overcome is implementing care at a time of growing disease burden and fewer clinical resources. Artificial intelligence-powered insights, like those provided by egnite, will enable us to ensure appropriate care is provided to our entire patient population.”

Key Points: 
  • egnite, Inc. , a leading digital health company for cardiovascular care, announces today the release of novel research presented at Heart Rhythm 2023.
  • Led by heart failure cardiologist John Mignone, the study utilized real-world data from egnite’s de-identified database of over 5.2 million cardiovascular patients from 20 leading heart programs across the United States.
  • “Over the last five years, new therapies to treat heart failure emerged with promising improvements in survival benefit.
  • “The next big challenge to overcome is implementing care at a time of growing disease burden and fewer clinical resources.

Medtronic Extravascular ICD global clinical trial results reinforce device safety and effectiveness

Retrieved on: 
Saturday, May 20, 2023
Heart, Mayo Clinic, Cardiac arrest, University, EV, Freedom, Vein, Heart failure, Arrest, Sternum, Blood vessel, Molina Healthcare, Medtronic, Department of Medicine – University of Pamplona, ATP, Shock, Lead, ICD, Buffalo, University at Buffalo, Biomedical sciences, Sale, Incidence, Kaplan–Meier estimator, Heart Rhythm, Ventricular tachycardia, Patient, Physician, Risk, Cardiology, Conductance quantum, Ventricular fibrillation, Longevity, NYSE, Medical device, Pharmaceutical industry, Medicine

DUBLIN and NEW ORLEANS, May 20, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced longer-term follow-up results of its investigational EV ICD™ System, designed to treat dangerously fast heart rhythms that can lead to sudden cardiac arrest. Findings from the Extravascular Implantable Cardioverter Defibrillator (EV ICD) Pivotal Study, including patients followed through an average of 17.1 months, were presented as late-breaking science at Heart Rhythm 2023 in New Orleans. The EV ICD system is investigational and not yet approved for sale or distribution in the United States.

Key Points: 
  • The system offers anti-tachycardia pacing (ATP), pause prevention pacing, and a device similar in size, shape, and battery longevity to transvenous ICDs.
  • Using a minimally invasive approach, the device is implanted below the left armpit (in the left mid-axillary region).
  • "The EV ICD system is the first to include all of this functionality in a single extravascular device."
  • First-time ICD recipients (225,444 patients, of which 179,638 were primary prevention) implanted with a Medtronic Evera™ or Visia™ single- or dual-chamber ICD were included.

Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies

Retrieved on: 
Saturday, May 20, 2023
Tricuspid valve, Heart Rhythm Society, EU, Freedom, Chosen-ciphertext attack, Heart failure, Pulmonary vein stenosis, Boston Scientific, BSX, Atrial fibrillation, Learning curve, FLX, ICD, NCDR, Catheter ablation, Arrhythmia, DOAC, Atrial tachycardia, Kaplan–Meier estimator, Heart Rhythm, Patient, Molina Healthcare, Physician, Electrophysiology, Data, Risk, LAAC, Diagnosis, Growth, AF, IDE, Ventricular fibrillation, Recurrence, Cardiology, NYSE, Disease, Safety, Journal of the American College of Cardiology, ATLAS, Medical imaging, Pharmaceutical industry, Nursing, Birth control, Medical device

MARLBOROUGH, Mass., May 20, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced data supporting use of the company's key electrophysiology and cardiac rhythm management therapies, and the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21.

Key Points: 
  • All data were presented at Heart Rhythm 2023, the annual meeting of the Heart Rhythm Society, held in New Orleans from May 19-21.
  • The registry data included favorable single procedure success rates, along with efficient procedure times in a broad patient population.
  • Data demonstrated a predictable workflow with a median of 58 minutes within an interquartile range of 40 to 87 minutes.
  • "The data shared at this year's Heart Rhythm meeting showcases the breadth and depth of our cardiology therapies, which spans from diagnosis to treatment of cardiac disease, and highlights the continued growth of our portfolio," said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific.