Atrial tachycardia

Volta Medical Receives CE Mark for AF-Xplorer™ Decision support solution to Simplify Complex Atrial Fibrillation Procedures

Retrieved on: 
Wednesday, February 28, 2024
CE, Artificial intelligence, Randomized controlled trial, MDR, FDA, Atrial tachycardia, Food, Growth, Database, E-GMS, European, Atrial fibrillation, Food and Drug Administration, Patient, Deep learning, Tailor, Medical device

This major step will enable sales and distribution of the new product in the European Union (EU).

Key Points: 
  • This major step will enable sales and distribution of the new product in the European Union (EU).
  • “We are pleased that Volta’s AF-Xplorer™ is now available in the EU to assist electrophysiologists in the treatment of patients with atrial fibrillation,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder.
  • This methodology facilitates a standardized approach to pinpointing what is known as spatiotemporal dispersed EGMs, a suspected source of AF.
  • Volta’s AF-Xplorer™ also received U.S. Food and Drug Administration (FDA) clearance in January 2023 for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures.

Biosense Webster Presents Late-Breaking Data from inspIRE and admIRE Clinical Trials at AF Symposium

Retrieved on: 
Saturday, February 3, 2024
Fluoroscopy, Arrhythmia, Catheter ablation, Workflow, Hospital, Atrial tachycardia, Success, Platform, 3D, Kansas Day, Patient, Safety, PFA, Johnson & Johnson, Recurrence, Freedom, Cardiac electrophysiology, Atrium (heart), Atrial flutter, Risk, Atrial fibrillation, Pharmaceutical industry

IRVINE, Calif., Feb. 2, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTechi, announced 12-month results from the company-sponsored inspIRE study, "Predictors of Success for Pulmonary Vein Isolation with Pulsed Field Ablation (PFA) Using a Variable Loop Catheter with 3D Mapping Integration: Complete 12-month outcomes from inspIRE," presented as a late-breaking presentation at the 29th Annual International AF Symposium.1 Interim results from the company-sponsored admIRE study, titled "PFA Using a Variable Loop Circular Catheter with 3D Mapping Integration: Early Outcomes of the admIRE Study," were also shared in a late-breaking presentation.2

Key Points: 
  • The CARTO™ System enables an intuitive and reproducible workflow with real-time visualization and feedback mechanisms.
  • "Biosense Webster is committed to bringing forward a versatile, differentiated portfolio of PFA solutions designed to help electrophysiologists deliver safe, effective, and efficient cardiac ablation procedures," said Jasmina Brooks, President, Biosense Webster, Inc. "The encouraging outcomes from clinical trials with VARIPULSE™ fuel our excitement as we continue to deliver innovations to meet the diverse needs and ablation strategies required to successfully treat atrial fibrillation."
  • The inspIRE study evaluated the safety and effectiveness of the VARIPULSE™ Platform for the treatment of drug-refractory paroxysmal AFib in Europe and Canada.1 In the study, the primary effectiveness endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence (AFib, Atrial Tachycardia, or Atrial Flutter) was 75.6%.
  • Among participants receiving optimal PFA applications, 80% achieved the primary effectiveness endpoint.1 The study reported a low fluoroscopy time of 7.8 minutes, partly attributed to the integration of the VARIPULSE™ Platform to the CARTO™ 3 System.

BIOTRONIK, INC. Announces First US Implant of Next-Generation Amvia Edge Pacemaker

Retrieved on: 
Tuesday, August 29, 2023
Atrial fibrillation, Atrial tachycardia, MRI, Mount Sinai Medical Center, Patient, Medical device, Medical imaging, Liquor

LAKE OSWEGO, Ore., Aug. 29, 2023 /PRNewswire/ -- BIOTRONIK , a leader in implantable medical device technology, today announced its first US implantation of the new Amvia Edge pacemaker.

Key Points: 
  • LAKE OSWEGO, Ore., Aug. 29, 2023 /PRNewswire/ -- BIOTRONIK , a leader in implantable medical device technology, today announced its first US implantation of the new Amvia Edge pacemaker.
  • Amvia Edge is BIOTRONIK's next-generation pacemaker family, featuring MRI Guard 24/7, the market's only dedicated, always-on MRI sensor.
  • Amvia Edge is the first pacemaker family from BIOTRONIK to offer EarlyCheck, another tool designed to simplify clinic workflow by automating pre-discharge checks.
  • "I was very pleased to have been a part of the first implant of Amvia Edge.

Biosense Webster Launches the OPTRELL™ Mapping Catheter with TRUEref™ Technology for Mapping of Complex Cardiac Arrhythmias

Retrieved on: 
Monday, July 24, 2023
Doctor of Philosophy, Arrhythmia, Atrial fibrillation, Food and Drug Administration, Atrial tachycardia, Electrode, Ventricular tachycardia, Patient, Physician, Map, Cardiology, FDA, Food, Medical imaging, Medical device, Johnson & Johnson, Ventricular fibrillation

IRVINE, Calif., July 24, 2023 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i today announced the U.S. launch of the OPTRELL™ Mapping Catheter with TRUEref™ Technology powered by the CARTO® 3 System. The OPTRELL™ Mapping Catheter is a high-density diagnostic catheter, with small electrodes arranged in a fixed array formation to provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases like persistent atrial fibrillation (AFib), redo AFib ablation, atrial tachycardia, and ventricular tachycardia.

Key Points: 
  • The OPTRELL™ Mapping Catheter is a high-density diagnostic catheter, with small electrodes arranged in a fixed array formation to provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases like persistent atrial fibrillation (AFib), redo AFib ablation, atrial tachycardia, and ventricular tachycardia.
  • Cardiac arrhythmias are a growing epidemic.
  • The OPTRELL™ Mapping Catheter with TRUEref™ Technology received U.S. Food and Drug Administration (FDA) 510(k) clearance in 2022 and is now available in the U.S.
  • The OPTRELL™ Mapping Catheter with TRUEref™ Technology will be commercially available in Japan later this year.

BIOTRONIK Receives FDA Approval For Next-Generation Family of Pacemakers

Retrieved on: 
Thursday, July 6, 2023
Atrial fibrillation, Stroke, Food and Drug Administration, Framingham Heart Study, Circulation (journal), Quality, Atrial tachycardia, MRI, Patient, Physician, Risk, Quality of life, FDA, Caregiver, Food, Safety, Medical imaging, Medical device, Self storage, Liquor

LAKE OSWEGO, Ore., July 6, 2023 /PRNewswire/ -- BIOTRONIK today announced U.S. Food and Drug Administration (FDA) approval of its portfolio of Amvia Edge pacemakers and cardiac resynchronization therapy pacemaker (CRT-P), its latest innovation in cardiac rhythm management. Amvia Edge, the market's smallest single-chamber MR conditional pacemaker1, introduces a unique set of patient-centric clinical solutions coupled with automated workflow efficiency.

Key Points: 
  • Amvia Edge, the market's smallest single-chamber MR conditional pacemaker1, introduces a unique set of patient-centric clinical solutions coupled with automated workflow efficiency.
  • The device returns to its permanent programming following the completion of the scan, eliminating any pre- or post-scan programming needs2,3.
  • Alongside its MRI and atrial arrhythmia solutions, Amvia Edge offers new tools that automate key tasks, such as pre-discharge checks.
  • BIOTRONIK Amvia Edge technical manual, Medtronic Azure XT DR MRI SureScan™ manual; Boston Scientific Accolade MRI™ technical manual; Abbott Assurity MRI™ user's manual.

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.

Volta Medical Announces FDA Clearance of Volta AF-Xplorer™ Software to Simplify Complex Atrial Fibrillation Procedures

Retrieved on: 
Thursday, May 18, 2023
Heart Rhythm Society, Database, CT, Ohio State University, Freedom, HRS, Workflow, Atrial fibrillation, Missing Link, Atrial tachycardia, Patient, Physician, Penn Presbyterian Medical Center, Artificial intelligence, Poster, E-GMS, AI, AF, Arrhythmia, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Software, Medical device, Medical imaging, DRS

MARSEILLE, France, May 18, 2023 (GLOBE NEWSWIRE) -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced that the U.S. Food and Drug Administration (FDA) has cleared Volta AF-Xplorer™, an AI companion designed for the assessment of complex AF and atrial tachycardia (AT) procedures. The company will showcase the latest solution at the 44th annual Heart Rhythm 2023, in New Orleans, LA, and virtually, from May 19-21.

Key Points: 
  • “There is a critical need for new ways to quickly and accurately identify abnormal electrograms (EGMs) for cardiac electrophysiologists to optimize their ablation strategy.
  • Volta AF-Xplorer offers a tailored and intuitive workflow while allowing physicians to use their preferred mapping system and catheter,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder.
  • The software upgrade features an enhanced integration with Abbott Laboratories’ EnSite X mapping system, providing improved workflow due to automated Volta “regions of interest” tagging capabilities.
  • The Volta Medical booth (#1340) will feature a demonstration of the Volta AF-Xplorer software.

Vektor Medical Releases Compelling Results for vMap Utility

Retrieved on: 
Thursday, May 18, 2023
Other Health, Research, General Health, Radiology, Pharmaceutical, Hospitals, Health Technology, Clinical Trials, Science, Cardiology, Biotechnology, Health, VT, Medicine, Probability, Atrial tachycardia, AT, Workflow, HRS, Vector, UC San Diego Health, ECG, Arrhythmia, Ventricular tachycardia, UC, Patient, AF, FDA, Automated ECG interpretation, Conference, Medical imaging

Vektor Medical , pioneers of the world’s first technology to accurately map arrhythmias using only 12-lead ECG data, today unveiled two studies further demonstrating clinical utility.

Key Points: 
  • Vektor Medical , pioneers of the world’s first technology to accurately map arrhythmias using only 12-lead ECG data, today unveiled two studies further demonstrating clinical utility.
  • The first study showcases vMap’s utility in unstable ventricular tachycardia (VT) ablation, sometimes called ‘unmappable VT’.
  • Results will be presented at the Heart Rhythm Society’s Annual Conference 2023 in New Orleans.
  • View the full release here: https://www.businesswire.com/news/home/20230518005342/en/
    The first of Vektor Medical's new studies, being presented at HRS 2023, showcases vMap’s utility in unstable ventricular tachycardia (VT) ablation.

Volta Medical Announces Completion of Patient Enrollment in TAILORED-AF Clinical Trial for Treatment of Atrial Fibrillation

Retrieved on: 
Thursday, February 2, 2023
Safety, MD, International, Arrhythmia, Freedom, Heart, Aad van den Hoek, Atrial tachycardia, Physician, Patient, Artificial intelligence, AT, EGM, Atrial fibrillation, AF, Pharmaceutical industry, Medical imaging

MARSEILLE, France, Feb. 02, 2023 (GLOBE NEWSWIRE) -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologist physicians in treating complex cardiac arrhythmias such as atrial fibrillation (AF), today announced the completion of patient enrollment in the randomized controlled clinical trial, TAILORED-AF, evaluating VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach.

Key Points: 
  • This technology ultimately may lead to optimized catheter-ablation procedures for complex arrhythmias, including persistent AF.
  • “Atrial fibrillation is the most common heart rhythm disturbance in adults and the need for more precise therapies is significant,” said Professor Isabel Deisenhofer, MD, of German Heart Center in Munich, Germany and primary investigator for the trial.
  • Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety.
  • “We are committed to helping physicians use EGM-assessment software to guide ablation and providing another clinical tool to support the best possible outcomes for patients,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder.

DGAP-News: Volta Medical's AI based solution for patients in atrial fibrillation achieves robust validation in first peer-reviewed publication

Retrieved on: 
Wednesday, August 31, 2022
Volta, Machine learning, EGM, CEO, Technology, JCE, Obesity, Arrhythmia, Artificial intelligence, Brain, Ageing, Entrepreneurship, AF, Catheter ablation, Heart, Business intelligence software, Heart failure, Atrial tachycardia, Electrophysiology, Physician, Stroke, Moyamoya disease, Common, Hospital, Journal, Deep learning, MD, Paola Lattus, E-GMS, Prevalence, Hypertension, FDA, Population, EV, Algorithm, Diabetes, Atrial fibrillation, Intuition, Journal of Cardiovascular Electrophysiology, Patient, Palpitations, Medical device, Medical imaging, Pharmaceutical industry, EU

The article titled Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation is available at https://onlinelibrary.wiley.com/doi/abs/10.1111/jce.15657 .

Key Points: 
  • The article titled Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation is available at https://onlinelibrary.wiley.com/doi/abs/10.1111/jce.15657 .
  • Results demonstrated that VX1 allowed for the building of standardized Volta VX1 maps, used as a reference for operators to conduct EGM-guided ablation.
  • The standardization of the detection of abnormal EGMs facilitated a robust patient-to-patient and center-to-center uniformity in EGM-based ablation.
  • Furthermore, after a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively.