Summary: Mechanical ventilation (MV) has changed very little over the past 20 years. Critically ill ICU patients who require Mechanical Ventilation (MV): 1) experience up to 50% diaphragm muscle atrophy in just 3 days; 2) are at risk of ventilator-induced lung injury; 3) are susceptible to ventilator related infections such as pneumonia; and 4) are at high risk for cognitive dysfunction. The severity of these complications increases with time on MV. When it comes time to breathe on their own, many patients have difficulty “weaning” off the ventilator, extending their ICU stay. Lungpacer has designed a therapy to protect and strengthen the diaphragm in MV dependent patients. The Diaphragm Pacing Therapy (DPT) system is comprised of a neurostimulation catheter, which activates the phrenic nerves causing the diaphragm muscle to replicate natural breathing, and an external control system. Published preclinical data demonstrate that Lungpacer therapy protects the diaphragm from atrophy. Early clinical data demonstrate significant reduction in the pressure required for MV and the ability to re-build diaphragm muscle strength. The DPT is therefore expected to reduce risks of diaphragm atrophy, lung injury and infection related complications, and to reduce the time to wean from MV. The DPT is expected to enable earlier discharge from the ICU and result in health care savings of $10,000 per treated patient.
Need: Mechanically ventilated ICU patients are at risk for rapid diaphragm muscle atrophy, suffer increased levels of lung injury, experience extended times weaning from MV and prolonged ICU/hospital stays, and have high mortality rates (Dres, 2017). The US population of prolonged MV patients is growing rapidly at 5.5% per year, and will exceed 625,000 patients by 2020 representing 10.3 million hospital days costing the US healthcare system $64 billion each year (Zilberberg, 2008, 2012). A majority of ICU patients describe dependence on MV as “worse than death” (Rubin, 2016). “Prolonged dependence on mechanical ventilation is an emerging public health problem” (Damuth 2015) and “efforts are urgently needed to increase liberation rates and improve survival” (Kahn, 2015).
Value: ICU MV patients are the most expensive patients in the global healthcare system. It is projected that in 2020 the over 625,000 US prolonged MV patients will cost $64 billion, or $6K per patient day. DPT use is expected to shorten ICU stays by approximately 2 days, saving at least $10,000 per patient, and expected to improve outcomes thereby providing healthcare practitioners and institutions strong incentive to drive adoption. FDA granted Lungpacer “breakthrough device” designation for its potential to save lives and improve outcome for MV patients who have difficulty weaning from MV. Lungpacer offers the potential to improve each patient’s experience, provide better clinical outcomes and reduce healthcare costs.