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About 225 results

ALLMedicine™ Diaphragm Pacing Center

Research & Reviews  66 results

Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
https://clinicaltrials.gov/ct2/show/NCT01938495

Mar 9th, 2023 - The study is a randomized controlled study to compare standard of care (control) to DPS (diaphragm stimulator named The NeuRx® Diaphragm Pacing System™). Although it remains uncertain if DPS is efficacious for the ALS subject, given the preliminar...

A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
https://clinicaltrials.gov/ct2/show/NCT03783884

Feb 13th, 2023 - The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). Th...

Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
https://clinicaltrials.gov/ct2/show/NCT04844892

Feb 6th, 2023 - The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to th...

Diaphragm Pacing: A Safety, Appropriateness, Financial Neutrality, and Efficacy Analysi...
https://doi.org/10.1016/j.neurom.2022.10.059
Neuromodulation : Journal of the International Neuromodul... Giberson CE, Cheshier SH et. al.

Jan 8th, 2023 - This study aimed to evaluate the safety and applicability of treating chronic respiratory insufficiency with diaphragm pacing relative to mechanical ventilation. A literature review and analysis were conducted using the safety, appropriateness, fi...

State-of-the-Art Opinion Article on Ventilator-Induced Diaphragm Dysfunction: Update on...
https://doi.org/10.1159/000527466
Respiration; International Review of Thoracic Diseases; Spiesshoefer J, Kersten A et. al.

Dec 2nd, 2022 - Evidence from both animal and human studies now supports the development of ventilator-induced diaphragm dysfunction (VIDD) starting as early as 24 h after initiation of mechanical ventilation in the intensive care unit (ICU). However, although th...

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Clinicaltrials.gov  17 results

Diaphragm Pacing System (DPS) In Participants With Amyotrophic Lateral Sclerosis (ALS)
https://clinicaltrials.gov/ct2/show/NCT01938495

Mar 9th, 2023 - The study is a randomized controlled study to compare standard of care (control) to DPS (diaphragm stimulator named The NeuRx® Diaphragm Pacing System™). Although it remains uncertain if DPS is efficacious for the ALS subject, given the preliminar...

A Protocol Comparing Temporary Transvenous Diaphragm Pacing to Standard of Care for Weaning From Mechanical Ventilation
https://clinicaltrials.gov/ct2/show/NCT03783884

Feb 13th, 2023 - The intended patient population is applicable for Lungpacer DPT because there are no noninvasive alternative treatments for patients who are difficult to wean from MV (i.e., ≥96 hours (4 days) on MV) or who have required prolonged MV (>7 days). Th...

Phrenic Nerve Stimulation-Induced Lung ReAeration Trial
https://clinicaltrials.gov/ct2/show/NCT04844892

Feb 6th, 2023 - The PIRAT clinical study is intended to assess the feasibility, safety and effectiveness of transvenous phrenic-nerve-stimulating diaphragm pacing on clinical outcomes in mechanically ventilated patients. By delivering electrical stimulation to th...

Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing
https://clinicaltrials.gov/ct2/show/NCT03096639

Nov 16th, 2022 - Mechanical ventilation (MV) is a life saving technology but can also cause damage to the lungs and diaphragm such as ventricular induced diaphragmatic dysfunction (VIDD). Research has shown that after being on mandatory MV and sedated the diaphrag...

Diaphragm Pacing in Individuals With Spinal Cord Injuries
https://clinicaltrials.gov/ct2/show/NCT04179799

Oct 27th, 2022 - Respiratory dysfunction is a leading cause of death in individuals with spinal cord injuries (SCIs). Nearly one-quarter of all SCI cases involve injury to the upper spinal cord segments which impairs neural activation of the diaphragm muscle and c...

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News  5 results

New Method Helps Restore Respiratory Muscle Function in Patients with Spinal Cord Injury
https://www.mdedge.com/fedprac/article/206827/orthopedics/new-method-helps-restore-respiratory-muscle-function-patients?channel=94
Jan Dyer

Aug 21st, 2019 - Many patients with spinal cord injury (SCI) need mechanical ventilatory support. One type of support is diaphragm pacing, which stimulates the diaphragm, helping the person breathe.

New Method Helps Restore Respiratory Muscle Function in Patients with Spinal Cord Injury
https://www.mdedge.com/fedprac/article/206827/orthopedics/new-method-helps-restore-respiratory-muscle-function-patients
Jan Dyer

Aug 21st, 2019 - Many patients with spinal cord injury (SCI) need mechanical ventilatory support. One type of support is diaphragm pacing, which stimulates the diaphragm, helping the person breathe.

Emergency Use Authorization
http://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Image On this page: About Emergency Use Authorizations (EUAs) EUA Guidance  COVID-19 EUAs In Vitro Diagnostic Products High Complexity Molecular-Based Laboratory Developed Tests SARS-CoV-2 Antibody Tests Personal Protective Equipment and Related M...

Diaphragm Pacing System Gets FDA Nod for ALS
https://www.medscape.com/viewarticle/750718

Sep 30th, 2011 - September 30, 2011 — The US Food and Drug Administration (FDA) has granted approval for the use of the NeuRx Diaphragm Pacing System to aid breathing in patients with amyotrophic lateral sclerosis (ALS). The system is approved for use in patients ...

FDA Grants Humanitarian Use Device Designation for Diaphragm Pacing System in ALS
https://www.medscape.com/viewarticle/730572

Oct 14th, 2010 - October 14, 2010 — The US Food and Drug Administration (FDA) has granted humanitarian use device designation for a diaphragm pacing system (NeuRx; Synapse Biomedical, Inc) in patients with amyotrophic lateral sclerosis (ALS) who have a stimulatabl...

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Patient Education  2 results see all →