Journal of Cardiovascular Electrophysiology

The Future of Single Chamber ICDs: BIOTRONIK Takes Unprecedented Market Stance with Proprietary DX Technology

Retrieved on: 
Monday, February 12, 2024
DX, Page, Journal of Cardiovascular Electrophysiology, ESC, Risk, Atrial fibrillation, ICD, PMID, American College, REACT, Patient, EACTS, Task force, Molina Healthcare, Guideline, Diagnosis, Update, MATRIX, Medical device

"We are very proud that our DX technology provides the only lead available on the market offering both ventricular pacing/defibrillation and atrial monitoring," said Ryan Walters, BIOTRONIK US President.

Key Points: 
  • "We are very proud that our DX technology provides the only lead available on the market offering both ventricular pacing/defibrillation and atrial monitoring," said Ryan Walters, BIOTRONIK US President.
  • "Due to DX´s ability to provide additional patient and clinical benefits, it became clear to us that we should be using DX technology with every BIOTRONIK single-chamber ICD."
  • Subclinical atrial fibrillation detection with a floating atrial sensing dipole in single lead implantable cardioverter-defibrillator systems: Results of the SENSE trial.
  • REACT DX registry: Real world REACTion to atrial high rate episodes detected in implantable cardioverter-defibrillator recipients with a DX lead.

BIOTRONIK's DX Technology Reaches Significant Milestone: 100,000 DX Devices Implanted

Retrieved on: 
Monday, January 29, 2024
Atrial fibrillation, Incidence, Meta-analysis, Health, Journal of Cardiovascular Electrophysiology, Systematic review, Feedback, MATRIX, Safety, BioMed Research International, DX, Page, ICD, Diagnosis, Physician, Medical device

BERLIN, Jan. 29, 2024 /PRNewswire/ -- BIOTRONIK announced the milestone achievement of 100,000 implanted single lead implantable cardioverter-defibrillators (ICDs) equipped with DX Technology enabling direct atrial sensing for atrial fibrillation (AF) detection and monitoring. Since the introduction of this unique technology in 2009, DX ICDs are used today by clinicians in more than 80 countries around the world.

Key Points: 
  • Since the introduction of this unique technology in 2009, DX ICDs are used today by clinicians in more than 80 countries around the world.
  • "Reaching this significant milestone, BIOTRONIK stands as a proud pioneer and partner in cardiac rhythm management.
  • Over the past decades, more than 20 clinical studies that enrolled over 4,000 patients have confirmed the safety and efficacy of DX Technology.
  • This strong foundation of clinical evidence has recently been enriched by the MATRIX study results , the largest clinical evaluation of DX Technology to date.

New Biosense Webster QDOT MICRO™ Catheter Data Demonstrate Very High-Power, Short-Duration Ablations Improved Quality of Life and Reduced Healthcare Utilization for AFib Patients

Retrieved on: 
Thursday, November 2, 2023
Catheter ablation, Incidence, Johnson & Johnson, Arrhythmia, Heart, RF, Physician, Atrial fibrillation, Elijah Cummings Lower Drug Costs Now Act, Catheter, Journal, Clinical electrophysiology, Quality of life, Caregiver, Recurrence, Electrophysiology, Freedom, Journal of Cardiovascular Electrophysiology, Safety, Cleveland Clinic, Patient, Pharmaceutical industry, Medical device, Nursing, Temperature, MD, Ventricular fibrillation

IRVINE, Calif., Nov. 2, 2023 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced new findings from the Q-FFICIENCY study were published in the Journal of Cardiovascular Electrophysiology demonstrating treatment with the QDOT MICRO™ Catheter significantly improved control of atrial fibrillation (AFib), relief of symptoms and overall quality of life.1

Key Points: 
  • The QDOT MICRO™ Catheter is a next-generation RF ablation catheter that incorporates advanced, high-energy ablation, improved temperature monitoring, optimized irrigation, and higher signal resolution.
  • In QMODE+™ setting, the catheter allows the delivery of very high-power, short-duration ablation – 90 watts for up to four seconds, significantly improving ablation efficiency.2 The QDOT MICRO™ Catheter is fully integrated with the CARTO® 3 System, enabling efficient and consistent lesion creation with a simplified workflow and lower total procedure time.2 Earlier this year, Biosense Webster announced the publication of the Q-FFICIENCY safety and 12-month efficacy data in JACC: Clinical Electrophysiology, which showed that the QDOT MICRO™ Catheter delivered high clinical success with 86% of patients experiencing freedom from symptomatic recurrence while catheter-related primary adverse events remained low at 1.8%.2
    "AFib places a substantial burden on patients' daily lives and healthcare resources, including physician visits, drug costs and side effects, and hospitalizations.
  • At Biosense Webster, we are focused on improving patient outcomes, while offering innovative solutions for physicians treating the growing number of AFib patients today," said Jasmina Brooks, President, Biosense Webster, Inc. "As the Q-FFICIENCY study findings demonstrate, use of the temperature-controlled QDOT MICRO™ Catheter allows physicians to customize treatment for each patient, reduce procedural times and offer significant benefits to patients through improving their quality of life."
  • AFib is the most common type of cardiac arrhythmia affecting an estimated 37.5 million people globally.3 Responsible for more than 450,000 hospitalizations and nearly 5 million physician visits in the U.S. annually, AFib places a heavy burden on patients, their caregivers and healthcare systems.4 Despite these projections, many people are unfamiliar with AFib symptoms, available treatment options and the importance of early treatment to avoid disease progression.5 Catheter ablation is a safe and effective procedure to restore the heart's incorrect electrical signals, which causes an abnormal heart rhythm.6

Update: BioSig’s PURE EP™ System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore

Retrieved on: 
Wednesday, December 14, 2022
Cleveland Clinic, Nautilus, Inc. v. Biosig Instruments, Inc., AF, Physician, Electrophysiology, Cardiac electrophysiology, Motion, Mayo Clinic, Security (finance), Associated, FDA, Journal, Trial of the century, Journal of Cardiovascular Electrophysiology, Risk, EGM, EST, Clinical study design, ECG, ST, EP, PURE, COVID-19, Patient, Medical imaging, Medical device, Pharmaceutical industry

Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations.

Key Points: 
  • Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations.
  • The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP™’s electrocardiogram (EGM) visualization to the conventional ECG recording system.
  • Study results demonstrated that the PURE EP™ System led to a mean procedure time reduction of 11.3 minutes.
  • Given that the mean cost of operating room time is approximately $37 per minute1, the procedural time savings demonstrated by the PURE EP™ System suggest potential cost savings of approximately $418.10 per procedure.

BioSig’s PURE EP™ System Demonstrates Potential Time and Cost Savings at the 15th APHRS Scientific Session in Singapore

Retrieved on: 
Wednesday, December 14, 2022
Cleveland Clinic, Nautilus, Inc. v. Biosig Instruments, Inc., AF, Physician, Electrophysiology, Cardiac electrophysiology, Motion, Mayo Clinic, Security (finance), Associated, FDA, Journal, Trial of the century, Journal of Cardiovascular Electrophysiology, Risk, EGM, EST, Clinical study design, ECG, ST, EP, PURE, COVID-19, Patient, Medical imaging, Medical device, Pharmaceutical industry

Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations.

Key Points: 
  • Results from the randomized study reveal the PURE EP™ System’s potential to promote shorter procedural times and higher cost savings during catheter ablations.
  • The primary objective was to determine the difference in procedural times when comparing ablations guided by PURE EP™’s electrocardiogram (EGM) visualization to the conventional ECG recording system.
  • Study results demonstrated that the PURE EP™ System led to a mean procedure time reduction of 11.3 minutes.
  • Given that the mean cost of operating room time is approximately $37 per minute1, the procedural time savings demonstrated by the PURE EP™ System suggest potential cost savings of approximately $418.10 per procedure.

BioSig’s PURE EP™ System Highlighted in the Journal of Atrial Fibrillation & Electrophysiology

Retrieved on: 
Tuesday, December 6, 2022
Atrial fibrillation, Cleveland Clinic, Nautilus, Inc. v. Biosig Instruments, Inc., Dick's Picks Volume 15, Arrhythmia, Physician, Mayo Clinic, Security (finance), FDA, Cleveland, 3D, CCDS, Journal, Trial of the century, Journal of Cardiovascular Electrophysiology, Risk, PVI, CEPS, HFA, MD, Confirmation, Research, PURE, COVID-19, Mobile phone, Pharmaceutical industry, Electrophysiology

PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logo tation produced by a 3D mapping system.

Key Points: 
  • PURE EP™’s HFA signal analysis was observed alongside the simultaneous signal anno New Primary Logo New Primary Logo tation produced by a 3D mapping system.
  • PURE EP™’s real-time HFA identified early local activation, providing a clear and precise location that served as the primary target for ablation therapy during the procedure.
  • By removing unnecessary distractions, the PURE EP™ System with HFA preserves the value of cardiac signals and delivers clear, actionable insights to today’s electrophysiologist.
  • 1 Koch W. Zachary; Chung, Roy (2022), Confirmation of Acute Pulmonary Vein Reconnection with Case Report: The Utilization of PURE EP’s High-Frequency Algorithm (HFA), Journal of Atrial Fibrillation & Electrophysiology, Volume 15, Issue 6, Nov 2022. https://jafib-ep.com/journal/volume-15-issue-6-nov-2022/confirmation-of-...
    2 Global Market Insights Inc. March 08, 2022.

BioSig Signs Master Research Agreement with Cleveland Clinic to Explore Expanded Applications for its Digital Signal Processing Technology

Retrieved on: 
Monday, October 24, 2022
Physician, U.S. Securities and Exchange Commission, Cardiovascular disease, Mayo Clinic, SEC, Main, Efficiency, PURE, Diagnosis, Education, NASDAQ, U.S. News & World Report, Arrhythmia, Patient, Hospital, Research, Security (finance), Cardiac electrophysiology, Electrophysiology, Cleveland Clinic, Risk, Journal of Cardiovascular Electrophysiology, Trial of the century, Company, Nautilus, Inc. v. Biosig Instruments, Inc., Journal, News, FDA, COVID-19, CCF, Pharmaceutical industry, Medical device

Under the terms of the research agreement, Cleveland Clinic will conduct physician initiated scientific research investigating PURE EPs potential to address common limitations of signal processing and signal use expansion during but not limited to electrophysiology ablation procedures.

Key Points: 
  • Under the terms of the research agreement, Cleveland Clinic will conduct physician initiated scientific research investigating PURE EPs potential to address common limitations of signal processing and signal use expansion during but not limited to electrophysiology ablation procedures.
  • The Company has selected Cleveland Clinic, a leading medical center of excellence, based on their world-class physician faculty, research competency, and mutual interest in leveraging digital signal processing technology to further advance the field of cardiac electrophysiology.
  • Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education.
  • BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias.

BioSig Invited to Attend and Sponsor Venice Arrhythmias 2022

Retrieved on: 
Wednesday, October 12, 2022
Physician, U.S. Securities and Exchange Commission, Mayo Clinic, SEC, PURE, Module, Science, NASDAQ, Cardiology, VeniceArrhythmias, Research, Security (finance), Atrial fibrillation, Saint David, ALFA, Cardiac electrophysiology, Electrophysiology, Risk, Journal of Cardiovascular Electrophysiology, Trial of the century, Company, Doctor of Philosophy, Industry, CEO, Cleveland Clinic, Congress, Nautilus, Inc. v. Biosig Instruments, Inc., Medical Center, GLOBE, St Davids, Journal, European, FHRS, FDA, COVID-19, Â, Leadership, Pharmaceutical industry, MD

Westport, CT, Oct. 12, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (BioSig or the Company) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP System, today announced that it has been invited to attend the 17th Edition Venice Arrhythmias 2022 Congressa Heart Rhythm Society sponsored program taking place from October 13-15, 2022 in Venice, Italy.

Key Points: 
  • Westport, CT, Oct. 12, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (BioSig or the Company) an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP System, today announced that it has been invited to attend the 17th Edition Venice Arrhythmias 2022 Congressa Heart Rhythm Society sponsored program taking place from October 13-15, 2022 in Venice, Italy.
  • Their research is impacting technological advancement in the industry, commented Kenneth L. Londoner, Chairman, and CEO of BioSig Technologies, Inc.
  • Venice Arrhythmias 2022 is a world-renown congress that convenes global experts and innovators in the field of heart rhythm disorders to discuss the latest scientific advances and cutting-edge technologies in cardiac electrophysiology, pacing, and clinical arrhythmology.
  • BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias.

BioSig Executes Purchase Agreement with Methodist Hospital, San Antonio and Expands Customer Base

Retrieved on: 
Friday, October 7, 2022
Physician, U.S. Securities and Exchange Commission, Mayo Clinic, SEC, Hospital, Growth, PURE, NASDAQ, EP, Transplant, Security (finance), Health, Electrophysiology, Risk, Journal of Cardiovascular Electrophysiology, Technology, Trial of the century, Company, Acquisition, Cleveland Clinic, Nautilus, Inc. v. Biosig Instruments, Inc., Journal, GLOBE, Methodist Hospital, FDA, COVID-19, Satellite navigation device, Pharmaceutical industry, MD

The acquisition, one of many in the pipeline, reaffirms the continued expansion of BioSigs U.S. footprint and customer base.

Key Points: 
  • The acquisition, one of many in the pipeline, reaffirms the continued expansion of BioSigs U.S. footprint and customer base.
  • Methodist Healthcare is recognized as a leading healthcare provider in South Texas, offering an outstanding selection of doctors, healthcare professionals, equipment and health services.
  • The hospital belongs to a network of hospitals in the greater San Antonio area, including nine acute care facilities: Methodist Hospital, Methodist Children's Hospital, Methodist Hospital Metropolitan, Methodist Hospital Northeast, Methodist Hospital Atascosa, Methodist Hospital Specialty and Transplant, Methodist Hospital Stone Oak and Methodist Hospital Texsan.
  • BioSig Technologies is an advanced digital signal processing technology company bringing never-before-seen insights to the treatment of cardiovascular arrhythmias.

BioSig Launches PURE EP™ Software Version 6 with ACCUVIZ™ Module

Retrieved on: 
Thursday, September 22, 2022
PAS, Global, Journal of Cardiovascular Electrophysiology, Trial of the century, Journal, Efficiency, COVID-19, Nursing, FDA, Company, Automatic tachycardia, Heart Rhythm Society, EP, Arrhythmia, U.S. Securities and Exchange Commission, Version 6 Unix, Program, Patient, Cleveland Clinic, Risk, Physician, Technology, Cleveland, Keystone Bop Vol. 2: Friday & Saturday, Nautilus, Inc. v. Biosig Instruments, Inc., NASDAQ, Module, Cardiology, Research, PURE, Mayo Clinic, GLOBE, Security (finance), SEC, Electrophysiology, HFA, ATC, Satellite navigation device, Pharmaceutical industry

Westport, CT, Sept. 22, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (BioSig or the Company), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP System, today announced the release of PURE EP Software Version 6 with ACCUVIZ Module.

Key Points: 
  • Westport, CT, Sept. 22, 2022 (GLOBE NEWSWIRE) -- BioSig Technologies, Inc. (NASDAQ: BSGM) (BioSig or the Company), an advanced digital signal processing technology company delivering unprecedented accuracy and precision to intracardiac signal visualization with its proprietary PURE EP System, today announced the release of PURE EP Software Version 6 with ACCUVIZ Module.
  • Built around three highly differentiating features, PURE EP Software Version 6 with ACCUVIZ Module introduces the proprietary High Frequency Algorithm (HFA), a novel feature that identifies the key frequency components of cardiac data that can be difficult to identify within the traditional waveform presentation.
  • PURE EP Software Version 6 with ACCUVIZ Module is the first to be designed and launched by the Companys new commercial and operations team and represents the most advanced iteration of the Companys digital signal processing technology.
  • PURE EP Software Version 6 with ACCUVIZ Module acquires raw intracardiac signals in their digital form to provide a new level of efficiency and automaticity.