The EAP is a new FDA program aimed to facilitate more rapid patient access to breakthrough technologies. The EAP status was granted for the Lungpacer DPS because the FDA agrees that it is intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition; that it may represent a breakthrough technology that provides a clinically meaningful advantage over existing legally marketed technology; and that the availability of the device may be in the best interest of patients because it addresses an unmet medical need.
“Our team is thrilled that the Lungpacer DPS was granted EAP status. This FDA action will enable our team to communicate more efficiently with the FDA to ensure the most rapid path to commercialization in order to help our patients. Mechanically ventilated patients can struggle with regaining the ability to breathe independently following extended illness, and we look forward to helping these individuals regain the ability to breathe independently faster,” commented Doug Evans, President and CEO.
With EAP designation, the FDA works with device manufacturers to try to reduce the time and cost from the start of product development to marketing approval, without changing the FDA’s approval standards. Components of the program, on the part of the FDA, include priority review, more interactive review, senior management involvement, and assignment of a case manager. Additionally, the program facilitates development of a potentially less burdensome premarket clinical trial, shifting a portion of data collection to the post-market phase, while still meeting the statutory standard of reasonable assurance of safety and effectiveness.
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 exercise and strengthen 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 restore diaphragm strength and endurance in patients who have failed to wean from MV after their diaphragm muscle atrophied as a consequence of VIDD thus saving many lives, improving patient outcomes, and greatly reducing 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