Lungpacer Medical, Inc. Announces Start of First-in-Human Early Feasibility Trial
BURNABY, British Columbia, Oct. 21, 2015 /PRNewswire/ -- Lungpacer Medical, Inc., a medical device company developing an intravenous catheter-based phrenic-nerve-pacing system, announced today the enrollment of the first patients in the Phrenic ACtivation for Enhanced Respiration (PACER) early feasibility trial. To date, five patients have been successfully tested in the company's First in Human (FiH) feasibility trial.
The PACER feasibility study was designed to determine initial safety and early feasibility of the Lungpacer IntraVenous Electrode (LIVE) Catheter and the diaphragm pacing method. Initial results are encouraging as the Lungpacer system demonstrated good functionality including the ability to reduce the mechanical ventilator pressure required to deliver breaths to the patients, consistent with the company's pre-clinical data.
"We are excited about the initial results from the PACER early feasibility study, which supports the potential for Lungpacer's novel therapy to help critically ill patients that are susceptible to ventilator induced diaphragm dysfunction and ventilator induced lung injury," said Dr. Steven Reynolds, MD, Regional Medical Director of Critical Care - Fraser Health Authority.
"Our team is thrilled with the initial outcomes from our FiH trial. Mechanical ventilator patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to exploring the potential for the LIVE Catheter to help these individuals regain the ability to breathe independently faster," commented Doug Evans, President and CEO.
About Ventilator-induced Diaphragm Atrophy and Lung Injury
Mechanical ventilation (MV) can be life-saving for many critically ill patients. However, MV can also be harmful to the patient as continued MV and sedation interrupt the normal activation of the diaphragm muscle, which then atrophies rapidly and profoundly (known as Ventilator Induced Diaphragm Dysfunction; VIDD). In addition, positive-pressure invasive ventilation can damage the lungs (Ventilator Induced Lung Injury; VILI) and is associated with Ventilator-Associated Pneumonia (VAP).
VIDD, VILI and VAP are key contributing factors to the frequent difficulty in weaning patients from the ventilator. About 31% of patients on MV are categorized as 'difficult to wean' and approximately 10% require prolonged weaning periods greater than seven days. These patients alone account for 40% of total ICU patient-days and become the most expensive in-patients in North American hospitals. When a critically ill patient becomes ventilator-dependent, the risk of dying in the ICU increases seven-fold.
About Lungpacer Medical, Inc.
Lungpacer Medical is a clinical stage medical device company pioneering the development of neurostimulation systems designed to preserve the integrity and strength of the diaphragm muscle and reduce complications in critically ill patients who require mechanical ventilation. The proprietary Lungpacer system is designed to activate the diaphragm using a temporary, minimally invasive, transvascular nerve stimulation approach that is expected to save many lives, improve patient outcomes and greatly reduce hospital care costs. The Lungpacer Diaphragm Pacing System is at this time an investigational device only and is not for sale in any country.
This press release contains "forward-looking statements" concerning the development of Lungpacer's products, the potential benefits and attributes of such products, and the company's expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Lungpacer undertakes no obligation to update any forward-looking statements for any reason.
For additional information about Lungpacer, please visit www.Lungpacer.com.
SOURCE Lungpacer Medical, Inc.
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