Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients Constanze Steinke Pressearbeit Universität Greifswald 07/10/2020 08:54 Department B for Internal Medicine of the University Medical Center Greifswald successfully used, within an international multi-center trial, a special diaphragmatic stimulation therapy to treat a COVID-19 patient as the first clinical site in Europe. “The first patient treated in this trial happened to be a woman who survived COVID-19 but was not able to be weaned from mechanical ventilation,” said Prof. Dr. Ralf Ewert, the head of the Pneumology, Infection Disease and Weaning Centre at the University Medical School of Greifswald. “With the new procedure, we were able to treat this patient, who is over 65 years old and has already spent 38 days on ventilator and enabled her return to independent breathing. In total we have now included four patients into the study and are pleased to contribute to this promising technology with our results,” says the Greifswald pneumologist and mechanical ventilation specialist. The Lungpacer® System by Lungpacer Medical Inc., a Canadian medical device company, is a novel technology that stimulates the phrenic nerves during mechanical ventilation and thus strengthens the weakened diaphragm muscle to assist in..
Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients
Constanze Steinke Pressearbeit Universität Greifswald
07/10/2020 08:54
Department B for Internal Medicine of the University Medical Center Greifswald successfully used, within an international multi-center trial, a special diaphragmatic stimulation therapy to treat a COVID-19 patient as the first clinical site in Europe.
“The first patient treated in this trial happened to be a woman who survived COVID-19 but was not able to be weaned from mechanical ventilation,” said Prof. Dr. Ralf Ewert, the head of the Pneumology, Infection Disease and Weaning Centre at the University Medical School of Greifswald. “With the new procedure, we were able to treat this patient, who is over 65 years old and has already spent 38 days on ventilator and enabled her return to independent breathing. In total we have now included four patients into the study and are pleased to contribute to this promising technology with our results,” says the Greifswald pneumologist and mechanical ventilation specialist.
The Lungpacer® System by Lungpacer Medical Inc., a Canadian medical device company, is a novel technology that stimulates the phrenic nerves during mechanical ventilation and thus strengthens the weakened diaphragm muscle to assist in weaning from the ventilator. The University Medicine Greifswald is the first hospital in Germany to participate in the so-called RESCUE-3 study, to provide safety and effectiveness data for the new procedure. In Germany, the system is currently only available as part of clinical studies.
Greifswald University Hospital tests new method (Lungpacer® System) for weaning of respiratory patients. Photo: Manuela Janke/UMG
Via Strengthening the Diaphragm Back to Life During the COVID 19 pandemic, there are more patients in hospitals requiring invasive mechanical ventilation over long periods of time. While mechanical ventilation is live-saving in the case of respiratory failure, it can also be harmful, especially if it is required over a longer period of time. Ventilators use positive pressure to push air into the lungs so that the main respiratory muscle, the diaphragm, is not used. The diaphragm is a plate consisting of muscles and tendons that separates the chest from the abdomen. As a result, mechanical ventilation and artificial immobilization of the patient quickly leads to loss of diaphragmatic strength. This is what doctors refer to as Ventilator-Induced Diaphragmatic Dysfunction.
The Lungpacer® System is designed to be easily integrated into the routine care of patients with invasive mechanical ventilation. The system uses the LIVE Catheter®, which is similar to central venous catheters used in most ventilated patients. The catheter can be used to inject fluids and medications and to stimulate the diaphragm and phrenic nerves to train the diaphragm muscle to assist in weaning. The Lungpacer® Control Unit is a mobile, portable unit used with the catheter and intermediate cable to provide temporary diaphragmatic neurostimulation.
Background RESCUE-3 Study The RESCUE-3 study, which started in 2019, is a randomized, controlled, open, multi-center adaptive clinical trial to investigate the safety and effectiveness of the Lungpacer® Diaphragm Pacing Therapy system for patients who have failed to wean from mechanical ventilation. Patients enrolled into the trial have failed two or more weaning attempts and stayed more than 96 hours (4 days) on mechanical ventilation. The study will enroll up to 376 subjects and will be conducted at up to 80 sites in the US, EU. Further information are available at http://www.lungpacer.com.
Universitätsmedizin Greifswald
Klinik und Poliklinik für Innere Medizin B
Direktor: Prof. Dr. med. Stephan Felix
Ferdinand-Sauerbruch-Straße, 17475 Greifswald
T +49 3834 86-80 500
E InnereB@med.uni-greifswald.de
Studienleiter: Prof. Dr. Ralf Ewert
E ewert@uni-greifswald.de
T +49 3834 86-80 595
Pressesprecher Christian Arns
T +49 3834 86-52 28
E christian.arns@med.uni-greifswald.de
http://www.medizin.uni-greifswald.de
http://www.facebook.com/UnimedizinGreifswald
Instagram/Twitter @UMGreifswald
Contact for scientific information: Studienleiter: Prof. Dr. Ralf Ewert
E ewert@uni-greifswald.de
T +49 3834 86-80 595
VANCOUVER, British Columbia, April 14, 2020 Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA letter, “patients at high risk of weaning failure include COVID-19 patients requiring ventilation and [other] patients being mechanically ventilated for other high-risk conditions including post-cardiac and post-thoracic surgical procedures and medical ICU patients requiring prolonged ventilation.” The approval states that “FDA has concluded that the Lungpacer DPTS may be effective at treating patients during COVID-19 by helping wean patients off ventilators in healthcare settings, thereby reducing their risks of prolonged mechanical ventilation and increasing the availability of ventilators during the COVID-19 pandemic.” Lungpacer CEO, Doug Evans, stated that “this amazing honor provides a unique opportunity to help improve outcomes for many patients affected by this global health crisis.”
VANCOUVER, British Columbia, April 14, 2020
Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today that the FDA has approved the Emergency Use Authorization for the use of the Lungpacer Diaphragm Pacing Therapy System (DPTS) to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure. According to the FDA letter, “patients at high risk of weaning failure include COVID-19 patients requiring ventilation and [other] patients being mechanically ventilated for other high-risk conditions including post-cardiac and post-thoracic surgical procedures and medical ICU patients requiring prolonged ventilation.” The approval states that “FDA has concluded that the Lungpacer DPTS may be effective at treating patients during COVID-19 by helping wean patients off ventilators in healthcare settings, thereby reducing their risks of prolonged mechanical ventilation and increasing the availability of ventilators during the COVID-19 pandemic.” Lungpacer CEO, Doug Evans, stated that “this amazing honor provides a unique opportunity to help improve outcomes for many patients affected by this global health crisis.”
An average of 14,000 pulmonary, critical care and sleep medicine clinicians and researchers from around the world attend the ATS multidisciplinary conference each year. Unfortunately, due to the COVID-19 global crisis the 2020 meeting has been cancelled. However, Lungpacer Medical, Inc. is pleased to announce that four preclinical abstracts were accepted for poster presentation, and one for podium presentation, all of which will be published. Lungpacer Medical, Inc. also had two abstracts selected for poster presentation on early markers of prolonged MV and economic outcomes at US hospitals. The abstracts are: Increased Hippocampal Apoptotic Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. (selected for podium presentation) Temporary Transvenous Phrenic-Nerve-Stimulated Diaphragm Neurostimulation During Mechanical Ventilation Preserves Homogeneity in Non-Injured Lungs, Rohrs, E., et al. Increased Hippocampal Cytokine-Mediated Neuroinflammation After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Negative Hippocampal Turnover Index After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Increased Presence of Neural Pro-Inflammatory Cells in the Hippocampus After 50 Hours of Gold-Standard Mechanical Ventilation in a Pre-Clinical Pig Model, Bassi, T., et al. Economic Outcomes Among..
An average of 14,000 pulmonary, critical care and sleep medicine clinicians and researchers from around the world attend the ATS multidisciplinary conference each year. Unfortunately, due to the COVID-19 global crisis the 2020 meeting has been cancelled. However, Lungpacer Medical, Inc. is pleased to announce that four preclinical abstracts were accepted for poster presentation, and one for podium presentation, all of which will be published. Lungpacer Medical, Inc. also had two abstracts selected for poster presentation on early markers of prolonged MV and economic outcomes at US hospitals. The abstracts are:
The Society of Critical Care Medicine (SCCM) is the largest non-profit medical organization dedicated to promoting excellence and consistency in the practice of critical care. With members in more than 100 countries, SCCM is the only organization that represents all professional components of the critical care team. Lungpacer Medical is pleased to announce the presentation of preclinical work on respiratory function at SCCM 2020. Better PaO2/FiO2 with Electrophrenic Transvenous Neurostimulation vs. Mechanical Ventilation Alone, Rohrs, E., et al.
The Society of Critical Care Medicine (SCCM) is the largest non-profit medical organization dedicated to promoting excellence and consistency in the practice of critical care. With members in more than 100 countries, SCCM is the only organization that represents all professional components of the critical care team. Lungpacer Medical is pleased to announce the presentation of preclinical work on respiratory function at SCCM 2020.
The inaugural ERS Respiratory Failure and Mechanical Ventilation conference gathered more than 400 delegates from 60 countries, representing a diverse mix of world-leading respiratory scientists, clinicians and allied healthcare professionals. Delegates witnessed more than 40 scientific sessions and there were over 70 abstracts presented, featuring cutting-edge clinical and scientific presentations, including findings from Lungpacer’s preclinical work. Lungpacer Medical is pleased to announce the presentation of preclinical results related to the use of diaphragm stimulation and respiratory function. Temporary Transvenous Diaphragm Neurostimulation Distributes Tidal Volume in a More Physiological Pattern Versus Mechanical Ventilation Alone, E. Rohrs, et al.
The inaugural ERS Respiratory Failure and Mechanical Ventilation conference gathered more than 400 delegates from 60 countries, representing a diverse mix of world-leading respiratory scientists, clinicians and allied healthcare professionals. Delegates witnessed more than 40 scientific sessions and there were over 70 abstracts presented, featuring cutting-edge clinical and scientific presentations, including findings from Lungpacer’s preclinical work. Lungpacer Medical is pleased to announce the presentation of preclinical results related to the use of diaphragm stimulation and respiratory function.
VANCOUVER, British Columbia, January 2020 Lungpacer Medical, Inc., announced the completion of enrollment and follow up in its RESCUE 2 European CE Mark randomized clinical trial. This is a randomized study that enrolled a total of 110 subjects in France and Germany and evaluated the safety and effectiveness of the Lungpacer Therapy System in subjects who were expected to have ventilator-induced diaphragm dysfunction (VIDD) and be difficult to wean from mechanical ventilation. Results from the study are expected to be presented at a major conference at the end of 2020.
VANCOUVER, British Columbia, January 2020
Lungpacer Medical, Inc., announced the completion of enrollment and follow up in its RESCUE 2 European CE Mark randomized clinical trial. This is a randomized study that enrolled a total of 110 subjects in France and Germany and evaluated the safety and effectiveness of the Lungpacer Therapy System in subjects who were expected to have ventilator-induced diaphragm dysfunction (VIDD) and be difficult to wean from mechanical ventilation. Results from the study are expected to be presented at a major conference at the end of 2020.
