Cardiac electrophysiology

Ra Medical Systems Announces the Presentation of Clinical Data at the European Heart Rhythm Association Congress

Retrieved on: 
Monday, January 23, 2023
Medical Devices, Health, Surgery, Clinical Trials, Cardiology, Biotechnology, Physician, Arrhythmia, Abstract, Electrophysiology, EP, NYSE, Congress, VIVO, Cardiac electrophysiology, Medical device

Ra Medical Systems, Inc. (NYSE American: RMED) (Ra Medical), a medical device and technology company focused on cardiac electrophysiology, announces that four abstracts with clinical data supporting its VIVO technology have been accepted for presentation at the European Heart Rhythm Association Congress (EHRA 2023) being held April 16-18, 2023 in Barcelona.

Key Points: 
  • Ra Medical Systems, Inc. (NYSE American: RMED) (Ra Medical), a medical device and technology company focused on cardiac electrophysiology, announces that four abstracts with clinical data supporting its VIVO technology have been accepted for presentation at the European Heart Rhythm Association Congress (EHRA 2023) being held April 16-18, 2023 in Barcelona.
  • VIVO, developed by Ra Medical’s wholly owned subsidiary Catheter Precision, is a proprietary AI system used to non-invasively identify the origin of ventricular arrhythmias prior to an ablation procedure.
  • “It is highly gratifying to present clinical data to the many electrophysiology thought leaders at the largest European meeting solely focused on arrhythmia management and treatment,” said David Jenkins, Ra Medical Executive Chairman.
  • “All four abstracts with VIVO clinical data submitted by leading physicians to the Congress were accepted for presentation following an extensive peer-review process.

First Look at Data on Biosense Webster's Investigational Pulsed Field Ablation Platform Presented at AF Symposium 2023

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Saturday, February 4, 2023
PFA, Data monitoring committee, Paroxysmal attack, PVI, President of the European Union, Trial of the century, Atrial fibrillation, Pulmonary vein stenosis, Vein, PF, Safety, Leona, Johnson & Johnson, Patient, Icahn School of Medicine at Mount Sinai, Mount, Clinical trial, Recurrence, Kansas Day, Reflex, Risk, Medical Affairs Bureau, Cardiac electrophysiology, Arrhythmia, IRE, Catheter, I-40, Mount Sinai Health System, Mount Sinai Hospital (Manhattan), MD, Medical imaging, Medical device, Pharmaceutical industry, Ventricular fibrillation, Medicine, Electrophysiology

IRVINE, Calif., Feb. 3, 2023 /PRNewswire/ -- Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced that positive results from the inspIRE company-sponsored clinical trial were presented as a late breaker, titled "Paroxysmal AF Ablation Using a Variable-Loop Pulsed Field Ablation Catheter Integrated with a 3D Mapping System: One-Year Outcomes from inspIRE," at the 28th Annual International AF Symposium.

Key Points: 
  • In addition to being presented as an AF Symposium late breaker, the data will be simultaneously published in Circulation: Arrhythmia and Electrophysiology.
  • Pulsed Field Ablation (PFA) represents a new approach to treating atrial fibrillation (AFib), utilizing a controlled electric field to ablate cardiac tissue through a process called irreversible electroporation (IRE).
  • In wave II, an independent Data Monitoring Committee declared early success after 186-patient enrollment and 60 patients completing 12-month follow-up.
  • VARIPULSE™ is a steerable, multielectrode, catheter enabling cardiac electrophysiological mapping and ablation functionalities through the investigational TRUPULSE™ Generator.

Mark Y. Lee, M.D., Named Medical Director of Electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center

Retrieved on: 
Thursday, January 19, 2023
Long Beach Medical Center, University, Cardiac electrophysiology, Education, FACC, Dartmouth–Hitchcock Medical Center, Cardiovascular disease, Internal medicine, Dysrhythmia, Ventricular tachycardia, Supraventricular tachycardia, Atrial fibrillation, Flecainide, Patient, Clinical trial, EP, Electrophysiology, Research, Hospital, Medical device

LONG BEACH, Calif., Jan. 19, 2023 /PRNewswire/ -- Mark Y. Lee, M.D ., FACC, has been named medical director of electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center .

Key Points: 
  • LONG BEACH, Calif., Jan. 19, 2023 /PRNewswire/ -- Mark Y. Lee, M.D ., FACC, has been named medical director of electrophysiology at MemorialCare Heart & Vascular Institute at Long Beach Medical Center .
  • As the new medical director of electrophysiology, Dr. Lee will work to further Long Beach Medical Center's efforts for electrophysiology clinical research and education.
  • "Dr. Lee has done amazing work to date at MemorialCare Heart & Vascular Institute at Long Beach Medical Center, and we are excited to have him take on this new role as medical director of electrophysiology," says Joe Kim, M.D., chief medical officer, MemorialCare Long Beach Medical Center.
  • "I was born at Long Beach Medical Center, so serving my local community these past seven years as an electrophysiologist has been a blessing," says Dr. Lee.

Varian Receives Investigational Device Exemption for Cardiac Radioablation Clinical Trial, RADIATE-VT

Retrieved on: 
Thursday, January 19, 2023
Associate, Muscle tissue, Radiation, Catheter ablation, PALO, CRA, Literature, Standard of care, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Siemens Healthineers, Cardiac electrophysiology, Safety, IDE, Hospital, FDA, Randomized controlled trial, Senior, Cone Health Women's Hospital, Therapy, Patient, Food, Investigational device exemption, Clinical trial, Sale, Brigham and Women's Hospital, Arrhythmia, Harvard Medical School, Workflow, Pharmaceutical industry, Medical device, Medicine, Varian

PALO ALTO, Calif., Jan. 19, 2023 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal RADIATE-VTTM clinical trial. The RADIATE-VT trial will be the first international, multi-center, randomized controlled trial to evaluate the safety and efficacy of cardiac radioablation (CRA) compared to repeat catheter ablation for patients with high-risk refractory ventricular tachycardia (VT).

Key Points: 
  • PALO ALTO, Calif., Jan. 19, 2023 /PRNewswire/ -- Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal RADIATE-VTTM clinical trial.
  • Subjects will be randomly assigned to undergo cardiac radioablation with Varian's CRA system or catheter ablation.
  • The system is designed to support the entire cardiac radioablation workflow, including targeting, planning, and treatment delivery.
  • Because of this, some institutions have offered patients cardiac radioablation, and these single institution experiences have been reported in the literature.

Ra Medical Systems Completes Merger with Catheter Precision

Retrieved on: 
Tuesday, January 10, 2023
Surgery, Medical Devices, Health, Health Technology, Cardiology, Medtronic, Medtech, CE, Arrhythmia, NYSE, Cardiac electrophysiology, Exercise, MDT, FDA, Catheter, Catheter ablation, St. Jude Medical, VIVO, Environment, Medical imaging

Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”) announces the completion of its previously announced stock-for-stock merger transaction with Catheter Precision, Inc., a company focused on the cardiac electrophysiology market.

Key Points: 
  • Ra Medical Systems, Inc. (NYSE American: RMED) (“Ra Medical” or the “Company”) announces the completion of its previously announced stock-for-stock merger transaction with Catheter Precision, Inc., a company focused on the cardiac electrophysiology market.
  • Medtech veteran and Catheter Precision CEO and founder David Jenkins has joined Ra Medical’s Board of Directors as Executive Chairman.
  • Catheter Precision’s product portfolio also includes the Amigo®, a robotic arm that serves as a catheter control device.
  • About the transaction, Mr. Jenkins stated, “We are excited to bring Catheter Precision into a public company environment via the merger with RMED, which allows us access to an additional pool of capital.

Acutus Medical Announces Full Market Release of next generation software platform AcQMap 8.5

Retrieved on: 
Monday, December 19, 2022
Software, Algorithm, AFIB, MD, Anatomy, Cardiac electrophysiology, Arrhythmia, Patient, Physician, Mitral valve, Femoral vein, Workflow, Senior, Medical imaging

CARLSBAD, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the full commercial release of AcQMap 8.5.

Key Points: 
  • CARLSBAD, Calif., Dec. 19, 2022 (GLOBE NEWSWIRE) -- Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced the full commercial release of AcQMap 8.5.
  • This next generation software platform introduces new algorithms and features to further improve the accuracy and workflow of non-contact ultrasound-based anatomical reconstruction.
  • “AcQMap 8.5 represents an important step forward in our technology roadmap with a specific focus on improving procedure workflow and physician experience,” said Derrick Chou, Senior Vice President & Chief Technology Officer of Acutus Medical.
  • Ultimately, AcQMap 8.5 provides a higher fidelity of anatomical accuracy and workflow efficiencies which allow for broader utilization of the AcQMap technology.

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.

Catheter Precision’s VIVO™ System Used in More Than 800 Procedures in Leading U.S. and European Hospitals

Retrieved on: 
Thursday, December 1, 2022
Cardiology, Surgery, Public Relations, Investor Relations, General Health, Health, Medical Devices, Communications, Health Technology, Special, Disease, Tripura Merger Agreement, AS, Common stock, Definitive, Security (finance), Cardiac electrophysiology, VIVO, Financial statement, Communication, NYSE American, Catheter, Patient, Workflow, Arrhythmia, Sumathi Best Television Current Reporting Award, WILL, Common, CE, FDA, COVID-19, ALL, COMMUNICATION, Private, RA, Anatomy, Hospital, Physician, NYSE, Amigo, Acquisition, AND, Exhibit, FORM, Public Sector Net Cash Requirement, Public–Private Investment Program for Legacy Assets, Sale, 8-K, Business, OR, Form 10-K, Plan, Medical device, Medical imaging, Holding company, Mergers and acquisitions, Shareholder

Catheter Precisions lead product, VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time.

Key Points: 
  • Catheter Precisions lead product, VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time.
  • Additionally, Catheter Precision is working toward a commercial launch of a vessel closure device, currently planned for the first half of 2023.
  • Catheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias.
  • It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products.

Catheter Precision’s VIVO™ Systems Used in More Than 20 Procedures at NYU Langone Hospital

Retrieved on: 
Tuesday, November 29, 2022
Medical Devices, Health, Surgery, General Health, Cardiology, Biotechnology, Special, Disease, Tripura Merger Agreement, AS, Common stock, Definitive, Arrhythmia, Security (finance), Cardiac electrophysiology, VIVO, Financial statement, Communication, NYSE American, Catheter, Workflow, Sumathi Best Television Current Reporting Award, WILL, Common, CE, FDA, COVID-19, Growth, ALL, COMMUNICATION, Private, RA, Anatomy, Physician, NYSE, Electrophysiology, Amigo, AND, Exhibit, NYU Langone Health, FORM, Public Sector Net Cash Requirement, Public–Private Investment Program for Legacy Assets, NYU Langone Hospital — Long Island, Sale, 8-K, Business, OR, Form 10-K, Plan, Medical device, Medical imaging, Holding company, Mergers and acquisitions, Shareholder

Catheter Precision, Inc. , a medical device and technology company focused on cardiac electrophysiology, announces the completion of more than 20 procedures at NYU Langone Hospital utilizing the VIVO System that enables physicians to identify the origin of arrhythmias pre-procedure.

Key Points: 
  • Catheter Precision, Inc. , a medical device and technology company focused on cardiac electrophysiology, announces the completion of more than 20 procedures at NYU Langone Hospital utilizing the VIVO System that enables physicians to identify the origin of arrhythmias pre-procedure.
  • Completing the first 20 cases with VIVO at NYU Langone hospital is another milestone demonstrating clinical acceptance of our VIVO system, said David Jenkins, Catheter Precision CEO.
  • Additionally, Catheter Precision is working toward a commercial launch of a vessel closure device, currently planned for the first half of 2023.
  • Under the terms of the definitive merger agreement with Ra Medical Systems, Catheter Precision will become a wholly owned subsidiary of Ra Medical Systems in a stock-for-stock reverse merger transaction.