Catheter ablation

Field Medical Announces First-in-Human Trials for Groundbreaking FieldForce™ Ventricular Pulsed Field Ablation Technology

Retrieved on: 
Thursday, May 9, 2024
PFA, Physics, Safety, Arrhythmia, Catheter ablation, HRS, PVC, MD, Cardiac electrophysiology, Workflow, Mount Sinai Health System, Ventricular tachycardia, Cardiac cycle, Patient, Atrial fibrillation, Boston Scientific, Medical device

CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic. The Ventricular Catheter Ablation Study, VCAS, will enroll up to 60 patients at up to 5 sites world-wide. The VCAS investigational study is a critical step towards demonstrating safety and performance of the FieldForce™ Ablation System, developed specifically to address the limitations of existing pulsed field ablation (PFA) and radiofrequency (RF) ablation systems, including a more time efficient treatment protocol for the treatment of ventricular arrhythmias. Preliminary results will be presented on May 16, 2024, at the Heart Rhythm Scientific Sessions in Boston, Mass.

Key Points: 
  • First and only contact force pulsed field ablation (PFA) system designed to transform treatment for millions with life-threatening ventricular arrhythmias.
  • CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic.
  • The Ventricular Catheter Ablation Study, VCAS , will enroll up to 60 patients at up to 5 sites world-wide.
  • Current ventricular catheter ablation methods involve lengthy procedures and significant risks associated with thermal ablation, like conventional RF ablation.

Field Medical Announces First-in-Human Trials for Groundbreaking FieldForce™ Ventricular Pulsed Field Ablation Technology

Retrieved on: 
Thursday, May 9, 2024
PFA, Physics, Safety, Arrhythmia, Catheter ablation, HRS, PVC, MD, Cardiac electrophysiology, Workflow, Mount Sinai Health System, Ventricular tachycardia, Cardiac cycle, Patient, Atrial fibrillation, Boston Scientific, Medical device

CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic. The Ventricular Catheter Ablation Study, VCAS, will enroll up to 60 patients at up to 5 sites world-wide. The VCAS investigational study is a critical step towards demonstrating safety and performance of the FieldForce™ Ablation System, developed specifically to address the limitations of existing pulsed field ablation (PFA) and radiofrequency (RF) ablation systems, including a more time efficient treatment protocol for the treatment of ventricular arrhythmias. Preliminary results will be presented on May 16, 2024, at the Heart Rhythm Scientific Sessions in Boston, Mass.

Key Points: 
  • First and only contact force pulsed field ablation (PFA) system designed to transform treatment for millions with life-threatening ventricular arrhythmias.
  • CARDIFF-BY-THE-SEA, Calif., May 9, 2024 /PRNewswire/ -- Field Medical,™ Inc., a pioneer in pulsed field cardiac catheter ablation technology, today announced the initiation of its first-in-human study for the FieldForce™ Ablation System at Na Homolce Hospital in Prague, Czech Republic.
  • The Ventricular Catheter Ablation Study, VCAS , will enroll up to 60 patients at up to 5 sites world-wide.
  • Current ventricular catheter ablation methods involve lengthy procedures and significant risks associated with thermal ablation, like conventional RF ablation.

Biosense Webster Launches New Version of CARTO™ 3 Electro-Anatomical Mapping System

Retrieved on: 
Wednesday, May 8, 2024
FDA, Module, Arrhythmia, Catheter ablation, Ventricular fibrillation, Map, Heart, Software, Doctor of Philosophy, FACC, Cardiology, Anatomy, Electrophysiology, Science, Patient, Acquisition, FESC, Multipolar, FHRS, FAM, Atrial fibrillation, Johnson & Johnson, Catheter, Medical imaging

IRVINE, Calif., May 8, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announces the launch of CARTO™ 3 System Version 8, the latest version of the company's leading three-dimension (3D) heart mapping system used in cardiac ablation procedures. The software features new modules including the CARTO ELEVATE™ Module and CARTOSOUND™ FAM Module, designed for efficiency, reproducibility, and accuracy for electrophysiologists performing catheter ablation procedures to treat patients with atrial fibrillation (AFib) and other arrhythmias.

Key Points: 
  • IRVINE, Calif., May 8, 2024 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, announces the launch of CARTO™ 3 System Version 8, the latest version of the company's leading three-dimension (3D) heart mapping system used in cardiac ablation procedures.
  • This new version advances the CARTO™ 3 mapping and ablation experience through enhanced signal analysis, improved substrate characterization, and utilization of ultrasound technology."
  • New optional CARTO™ 3 System Version 8 modules include:
    CARTOSOUND™ FAM: the first use of an artificial intelligence algorithm, cleared by the FDA in intracardiac ultrasound for Biosense Webster.
  • "Accuracy and precision in mapping the heart when treating cardiac arrhythmias are critical for electrophysiologists, and therefore, our patients," continued Dr. Di Biase.

Adagio Medical Announces CE Mark approval of VT Cryoablation System, Plans for Immediate Commercialization in Select European Centers

Retrieved on: 
Monday, March 25, 2024
CE marking, Temperature, Electrophysiology, Atrial fibrillation, Patient, Journal, Ventricular tachycardia, Science, McGill University Health Centre, MD, CCB, Tachycardia, Catheter ablation, Division, Arrhythmia, Catheter, Adagio, Medical device

The system consists of the upgraded cryoablation console, also capable of supporting atrial ablation procedures using commercially available iCLAS™ catheters, and the vCLAS™ ventricular cryoablation catheter ("vCLAS").

Key Points: 
  • The system consists of the upgraded cryoablation console, also capable of supporting atrial ablation procedures using commercially available iCLAS™ catheters, and the vCLAS™ ventricular cryoablation catheter ("vCLAS").
  • The system will be featured at the upcoming conference of the European Heart Rhythm Association ("EHRA") in Berlin on April 7-9, 2024 and will become immediately available for clinical use in select European centers.
  • Unlike conventional radiofrequency ("RF") catheters commonly used for both ventricular and atrial procedures, the 9Fr, bi-directional deflectable vCLAS catheter was designed specifically to address the challenges of VT ablations.
  • CE Mark approval for the vCLAS catheter has been granted based on the results of the Cryocure-VT trial, which enrolled patients with monomorphic VT of both ischemic and non-ischemic origin at nine European and Canadian centers.

Global Pediatric Interventional Cardiology Market Forecast 2024-2030: PIC Market Forecast for 6.36% CAGR Between 2024 to 2030 - ResearchAndMarkets.com

Retrieved on: 
Thursday, February 29, 2024
General Health, Health, Cardiology, Heart, Incidence, Procedure, Catheter, Birth defect, Investment, Physician, Moyamoya disease, Congenital heart defect, Projection, VSD, Angioplasty, Prevalence, CHD, Coronary thrombosis, Atherectomy, Patient, Stent, Ventricular septal defect, CDC, Catheter ablation, Research, Medical imaging

The Pediatric Interventional Cardiology Market is forecasted to reach US$ 3.91 Billion through 2030.

Key Points: 
  • The Pediatric Interventional Cardiology Market is forecasted to reach US$ 3.91 Billion through 2030.
  • The pediatric interventional cardiology market proportion is expanding swiftly, driven by the rising prevalence of cardiac disorders in children and technological advancements.
  • The Stents segment is anticipated to dominate the global pediatric interventional cardiology market throughout the forecast period.
  • The comprehensive infrastructure of hospitals, coupled with their ability to provide diverse pediatric cardiology services, positions them as key contributors to the growth and development of the Pediatric Interventional Cardiology market.

Adagio Medical To List on Nasdaq Through Business Combination with ARYA Sciences Acquisition Corp IV, Enabling Further Commercial and Clinical Development of Innovative Cardiac Ablation Technologies

Retrieved on: 
Wednesday, February 14, 2024
Acquisition, Jefferies Group, Stifel, Form, Arrhythmia, Reed Smith, Kirkland & Ellis, Atrial fibrillation, Patient, Tachycardia, LLP, White & Case, Catheter ablation, Investment, PFCA, Security (finance)

LAGUNA HILLS, Calif., Feb. 14, 2024 /PRNewswire/ -- Adagio Medical, Inc. ("Adagio Medical"), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, and ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD) ("ARYA"), a special purpose acquisition company that is sponsored by an affiliate of Perceptive Advisors, LLC ("Perceptive Advisors"), today announced they have entered a definitive agreement (the "business combination agreement") for a business combination (the "transaction"). Upon closing of the transaction, Adagio Medical will become a subsidiary of Aja Holdco, Inc. (the "Combined Company"), which will operate with the existing Adagio Medical management team under the name "Adagio Medical, Inc." The Combined Company's common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol "ADGM".

Key Points: 
  • Investors in the financing include affiliates of Perceptive Advisors, RA Capital Management ("RA Capital"), RTW Investments and ATW Partners.
  • "In Adagio Medical, we've come to believe that the company's innovative cardiac ablation technology, thoughtful commercialization strategy, and experienced leadership team make it an exceptional fit to meet our objectives."
  • The respective boards of directors of both ARYA and Adagio Medical have approved the proposed transaction.
  • Jefferies LLC ("Jefferies") is acting as financial and capital markets advisor to ARYA, as well as sole private placement agent.

Adagio Medical To List on Nasdaq Through Business Combination with ARYA Sciences Acquisition Corp IV, Enabling Further Commercial and Clinical Development of Innovative Cardiac Ablation Technologies

Retrieved on: 
Wednesday, February 14, 2024
Acquisition, Jefferies Group, Stifel, Form, Arrhythmia, Reed Smith, Kirkland & Ellis, Atrial fibrillation, Patient, Tachycardia, LLP, White & Case, Catheter ablation, Investment, PFCA, Security (finance)

LAGUNA HILLS, Calif., Feb. 14, 2024 /PRNewswire/ -- Adagio Medical, Inc. ("Adagio Medical"), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, and ARYA Sciences Acquisition Corp IV (Nasdaq: ARYD) ("ARYA"), a special purpose acquisition company that is sponsored by an affiliate of Perceptive Advisors, LLC ("Perceptive Advisors"), today announced they have entered a definitive agreement (the "business combination agreement") for a business combination (the "transaction"). Upon closing of the transaction, Adagio Medical will become a subsidiary of Aja Holdco, Inc. (the "Combined Company"), which will operate with the existing Adagio Medical management team under the name "Adagio Medical, Inc." The Combined Company's common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol "ADGM".

Key Points: 
  • Investors in the financing include affiliates of Perceptive Advisors, RA Capital Management ("RA Capital"), RTW Investments and ATW Partners.
  • "In Adagio Medical, we've come to believe that the company's innovative cardiac ablation technology, thoughtful commercialization strategy, and experienced leadership team make it an exceptional fit to meet our objectives."
  • The respective boards of directors of both ARYA and Adagio Medical have approved the proposed transaction.
  • Jefferies LLC ("Jefferies") is acting as financial and capital markets advisor to ARYA, as well as sole private placement agent.

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.

MARKETVUE® REPORT: Arrhythmogenic Cardiomyopathy Gene Therapy Research Gains Momentum

Retrieved on: 
Tuesday, November 7, 2023
Catheter ablation, ICD, PKP2, Penetrance, Physician, Arrhythmogenic cardiomyopathy, REACH, Quality of life, Disease, Risk, Arrhythmia, Subcutaneous Implantable Defibrillator (S-ICD), ACM, Patient, Heart, Mutation, Medical device, Vaccine

NEWTON, Mass., Nov. 7, 2023 /PRNewswire/ -- Arrhythmogenic Cardiomyopathy (ACM) is a rare hereditary cardiac disorder characterized by progressive replacement of myocardial tissue with fibrofatty deposits, leading to life-threatening arrhythmias and cardiac dysfunction.

Key Points: 
  • ~70% of physicians surveyed by REACH Market Research report there is an extremely high unmet medical need for novel treatments for ACM.
  • NEWTON, Mass., Nov. 7, 2023 /PRNewswire/ -- Arrhythmogenic Cardiomyopathy (ACM) is a rare hereditary cardiac disorder characterized by progressive replacement of myocardial tissue with fibrofatty deposits, leading to life-threatening arrhythmias and cardiac dysfunction.
  • ACM patients typically receive treatment with beta blockers and anti-arrhythmic drugs to manage symptoms and arrhythmias.
  • To access REACH's MarketVue® Report on ACM, visit https://reachmr.com or contact us at [email protected] .

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