Phrenic nerve

Pulsed Field Ablation Innovator Argá Medtech Announces €54 Million Oversubscribed Series B Capital Raise

Retrieved on: 
Tuesday, February 27, 2024
SAN, PFA, Physician, Phrenic nerve, IDE, Arrhythmia, Risk, Medtech, Atrial fibrillation, Patient, Heart, Tissue, Esophagus

LAUSANNE, Switzerland and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Argá Medtech, a private company developing Coherent Sine-Burst Electroporation™ (CSE™), a next-generation cardiac ablation system for treating cardiac arrhythmias, including atrial fibrillation (AF), today announced the closure of a €54M oversubscribed Series B funding. The round was led by the existing investors, Advent Life Sciences (UK) and Earlybird Health (Germany), as well as new investor Gilde Healthcare (the Netherlands) and an undisclosed strategic investor. The financing enables Argá Medtech to advance the development of its innovative CSE™ Pulsed Field Ablation (PFA) system for treating AF through the execution of an IDE study in the US and a CE Mark study in the EU. With the funding, the company will also expand its US offices in San Diego, CA, in anticipation of its US clinical activities.  

Key Points: 
  • The financing enables Argá Medtech to advance the development of its innovative CSE™ Pulsed Field Ablation (PFA) system for treating AF through the execution of an IDE study in the US and a CE Mark study in the EU.
  • With the funding, the company will also expand its US offices in San Diego, CA, in anticipation of its US clinical activities.
  • “We are pleased to secure the support of such marquee investors who believe that Argá Medtech will revolutionize the atrial fibrillation ablation field,” said David Neale, CEO of Argá Medtech.
  • Argá Medtech’s CSE™ system uses a sinusoidal/sine wave, while other PFA platforms are typically powered by square wave energy sources.

Medtronic creates history with FDA approval of its novel PulseSelect™ Pulsed Field Ablation System to treat atrial fibrillation

Retrieved on: 
Wednesday, December 13, 2023
St Davids, Research, Safety, NYSE, Cryoablation, Medical Center, Chosen-ciphertext attack, Medtronic, Patient, PVI, European, FDA, CE, Atrial fibrillation, PFA, Cryo, MD, Diagnosis, Phrenic nerve, Learning curve, Catheter, Electrode, EP, SVP, Cosmetics, Medical device

DUBLIN, Dec. 13, 2023 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the PulseSelect Pulsed Field Ablation (PFA) System for the treatment of both paroxysmal and persistent atrial fibrillation (AF). This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.

Key Points: 
  • This is the first PFA technology to receive FDA approval and follows the recent European CE (Conformité Européenne) Mark of the PulseSelect PFA system in November.
  • "Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency1.
  • The learning curve in using the catheter and system is short, and the catheter enables the operator to deliver fast and controlled pulsed field energy for AF ablation."
  • The PulseSelect PFA system also includes the following:
    Designed as a plug-and-play system, PulseSelect can be used with any mapping system or with just fluoroscopy2.

ZOLL remedē System, a Breakthrough Therapy for Treating Central Sleep Apnea, Receives Approval for MRI Conditional Use

Retrieved on: 
Wednesday, May 24, 2023
Other Health, Radiology, Hardware, Medical Devices, Technology, Health Technology, Cardiology, Biotechnology, Neurology, Other Technology, FDA, Health, Life, Central sleep apnea, CSA, Respiration, Diaphragm, Spine, Asahi Kasei, Brain, MRI, Magnetic resonance imaging, Patient, Hamad Medical Corporation, Phrenic nerve, Longevity, Medical imaging, Medical device

ZOLL’s remedē System is an implantable transvenous phrenic nerve stimulation therapy for the treatment of adults with moderate to severe Central Sleep Apnea (CSA).

Key Points: 
  • ZOLL’s remedē System is an implantable transvenous phrenic nerve stimulation therapy for the treatment of adults with moderate to severe Central Sleep Apnea (CSA).
  • Full-body MRI approval applies to all models of remedē System, covering new remedē patients as well as those who already have a remedē device.
  • Approval of the remedē System for conditional use with MRI will allow those patients to now have access to this important therapy,” said Dr. Asim Roy, medical director of the Ohio Sleep Medicine Institute.
  • FDA approval to use full-body MRI on remedē patients is a significant milestone for ZOLL and the remedē therapy.”
    The remedē System was approved by the FDA in 2017.

ZOLL Announces Five-Year Study Confirming Safety, Efficacy and Beneficial Effects of Long-Term Transvenous Phrenic Nerve Stimulation (the remedē System)

Retrieved on: 
Monday, May 17, 2021
General Health, FDA, Medical devices, Health, Clinical trials, Branches of biology, Clinical medicine, Medicine, Sleep disorders, Central sleep apnea, Sleep apnea, Apnea, Phrenic nerve, Neuromodulation, Transoral robotic surgery, Neural dust, ZOLL Medical Corporation, Asahi Kasei, ZOLL MEDICAL CORPORATION, ASAHI KASEI

The data show sustained safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA).

Key Points: 
  • The data show sustained safety and efficacy of transvenous phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea (CSA).
  • We congratulate all of the coauthors, study investigators, and patients who have contributed to the data collection and publication of this five-year study.
  • ZOLL is a registered trademark of ZOLL Medical Corporation in the United States and/or other countries.
  • Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes.

Respicardia Announces Highmark Coverage for the remedē® System in Patients with Central Sleep Apnea

Retrieved on: 
Thursday, January 7, 2021
Branches of biology, Sleep disorders, Central sleep apnea, Sleep apnea, Apnea, Sleep, Phrenic nerve, Obstructive sleep apnea, Avery Biomedical Devices

Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health.

Key Points: 
  • Central Sleep Apnea (CSA) is a serious breathing disorder that disrupts the normal breathing pattern during sleep and negatively affects quality of life and overall cardiovascular health.
  • The remed System is indicated for moderate to severe Central Sleep Apnea in adult patients.
  • remed System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea Outcomes of Phrenic Nerve Stimulation for Central Sleep Apnea, Sleep.
  • Effects Of Transvenous Phrenic Nerve Stimulation On Central Sleep Apnea And Sleep Architecture: The 5 Year Analysis [abstract].

Treatment Benefits of the remedē® System Sustained Through 36 Months in Patients with Central Sleep Apnea

Retrieved on: 
Wednesday, July 10, 2019
Branches of biology, Sleep disorders, Organ systems, Neuroscience, Central sleep apnea, Sleep apnea, Neuromodulation, Apnea, Sleep study, Polysomnography, Phrenic nerve, Sleep

Patients from the remed System Pivotal Trial were assessed at 24 months (full overnight, in-lab, attended polysomnogram) and 36 months (home sleep study of cardiorespiratory polygraphy) to evaluate sleep metrics and safety.

Key Points: 
  • Patients from the remed System Pivotal Trial were assessed at 24 months (full overnight, in-lab, attended polysomnogram) and 36 months (home sleep study of cardiorespiratory polygraphy) to evaluate sleep metrics and safety.
  • Phrenic Nerve Stimulation has enormous potential to treat central sleep apnea patients who currently have few therapeutic options.
  • The remed System is indicated for moderate to severe Central Sleep Apnea in adult patients.
  • remed System Pivotal Trial Study Group, Long-term Efficacy and Safety of Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea Outcomes of Phrenic Nerve Stimulation for Central Sleep Apnea, Sleep.