Ventricular tachycardia

Philips presents study results at Heart Rhythm Annual Meeting demonstrating benefits of its AI-powered cardiac monitoring solutions

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Venerdì, Maggio 17, 2024

Syncope may be caused by a serious heart condition and cardiac monitoring solutions are often used to detect adverse heart rate and/or rhythm events to improve how syncope patients are diagnosed and managed.

Key Points: 
  • Syncope may be caused by a serious heart condition and cardiac monitoring solutions are often used to detect adverse heart rate and/or rhythm events to improve how syncope patients are diagnosed and managed.
  • Philips’ study reveals that AI-powered ECG biomarker technology may help to identify patients with significant intermittent bradyarrhythmia, potentially improving timely diagnosis and management.
  • While ambulatory cardiac monitors are frequently used to diagnose arrhythmias, their impact on clinical decision-making has not been extensively studied.
  • For more information on Philips’ presence at HRS, join in person at booth #1135 in the Boston Convention and Exhibition Center or visit Heart Rhythm 2024 .

Adagio Medical Announces First European Commercial Procedures and Commencement of U.S. FDA Pivotal IDE for Ventricular Tachycardia Cryoablation System

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Giovedì, Maggio 16, 2024

Adagio Medical, Inc. (“Adagio Medical”, “Adagio” or the “Company”), a leading innovator in catheter ablation technologies for ventricular tachycardia (“VT”) and atrial fibrillation (“AF”), today announced the completion of the first commercial procedures using its recently CE-Marked VT Cryoablation System and the U.S. Food and Drug Administration (“FDA”) approval of the FULCRUM-VT Pivotal IDE study of the VT Cryoablation System.

Key Points: 
  • Adagio Medical, Inc. (“Adagio Medical”, “Adagio” or the “Company”), a leading innovator in catheter ablation technologies for ventricular tachycardia (“VT”) and atrial fibrillation (“AF”), today announced the completion of the first commercial procedures using its recently CE-Marked VT Cryoablation System and the U.S. Food and Drug Administration (“FDA”) approval of the FULCRUM-VT Pivotal IDE study of the VT Cryoablation System.
  • That data, in combination with the Cryocure-VT dataset support FDA approval for the conversion of the FULCRUM-VT study to pivotal phase.
  • The vCLAS™ Cryoablation Catheter, a component of the Adagio Medical, Inc. VT Cryoablation System is intended to create transmural linear and focal lesions to cardiac structures within the endocardium of the ventricles with cryoablation.
  • Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies.

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

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Giovedì, Maggio 9, 2024

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: 
Giovedì, Maggio 9, 2024

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.

Thermedical Successfully Completes Feasibility Study for Treating Cardiac Arrhythmias Using Pulsed Field Ablation in Combination with SERF Ablation

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Martedì, Aprile 23, 2024

Thermedical ®, a developer of advanced thermal-ablation systems to treat ventricular arrhythmias, announced today that it has completed a feasibility study utilizing Pulsed Field Ablation (PFA) therapy in combination with its SERF Ablation System and Durablate® Catheter for treating ventricular tachycardia (VT).

Key Points: 
  • Thermedical ®, a developer of advanced thermal-ablation systems to treat ventricular arrhythmias, announced today that it has completed a feasibility study utilizing Pulsed Field Ablation (PFA) therapy in combination with its SERF Ablation System and Durablate® Catheter for treating ventricular tachycardia (VT).
  • PFA is an emerging technique that harnesses pulsed electrical field energy to deliver swift and precise tissue ablation in thin layers of the heart.
  • “We are encouraged by the results from our pre-clinical feasibility study evaluating PFA technology integrated into our SERF Ablation System with the Durablate Catheter.
  • The addition of PFA therapy to SERF ablation may offer a more complete approach to VT ablation and a practice-changing technology.

FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose

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Lunedì, Aprile 8, 2024

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.

Key Points: 
  • Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
  • "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
  • Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

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Mercoledì, Marzo 27, 2024

“We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”

Key Points: 
  • “We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”
    The prospective, randomized study, “Evaluation of Nalmefene HCl Injection for Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in an Emergency Department,” will compare the efficacy and safety of nalmefene HCl injection to naloxone injection in the treatment of recurrent respiratory depression due to opioid overdose.
  • Nalmefene HCl injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected opioid overdose.
  • Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.1 The Company distributes nalmefene HCl injection for no profit.
  • The study will be independently developed and carried out by UNM’s research team with Purdue Pharma providing only funding and nalmefene HCI injection.

Texas Cardiac Arrhythmia Institute at St. David's Medical Center to host international conference on complex cardiac arrhythmias

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Martedì, Marzo 26, 2024

AUSTIN, Texas, March 26, 2024 /PRNewswire/ -- On April 18 and 19, 2024, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center will host its seventh international symposium on complex arrhythmias, EPLive 2024.

Key Points: 
  • AUSTIN, Texas, March 26, 2024 /PRNewswire/ -- On April 18 and 19, 2024, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center will host its seventh international symposium on complex arrhythmias, EPLive 2024.
  • Live cases, which are broadcast with expert commentary from the state-of-the-art Electrophysiology Center at St. David's Medical Center, will serve as the primary teaching tool.
  • The Texas Cardiac Arrhythmia Institute features the leading robotic electrophysiology center in North America.
  • The 72,000-square-foot center, which opened in 2019, includes six electrophysiology labs equipped with advanced technology for treatment of complex arrhythmias.

Texas Cardiac Arrhythmia Institute at St. David's Medical Center to host international conference on complex cardiac arrhythmias

Retrieved on: 
Martedì, Marzo 26, 2024

AUSTIN, Texas, March 26, 2024 /PRNewswire/ -- On April 18 and 19, 2024, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center will host its seventh international symposium on complex arrhythmias, EPLive 2024.

Key Points: 
  • AUSTIN, Texas, March 26, 2024 /PRNewswire/ -- On April 18 and 19, 2024, the Texas Cardiac Arrhythmia Institute (TCAI) at St. David's Medical Center will host its seventh international symposium on complex arrhythmias, EPLive 2024.
  • Live cases, which are broadcast with expert commentary from the state-of-the-art Electrophysiology Center at St. David's Medical Center, will serve as the primary teaching tool.
  • The Texas Cardiac Arrhythmia Institute features the leading robotic electrophysiology center in North America.
  • The 72,000-square-foot center, which opened in 2019, includes six electrophysiology labs equipped with advanced technology for treatment of complex arrhythmias.

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

Retrieved on: 
Lunedì, Marzo 25, 2024

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.