Healthcare company Fresenius Medical Care North America (FMCNA) revealed on Monday that its heart and lung support system Novalung, for treating acute respiratory or cardiopulmonary failure, has received approval from the US Food and Drug Administration (FDA) .
According to the company, Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support. Recent research has shown a significant increase in the use of ECMO with evidence of improved survival rates and no increase in hospitalization costs. Patients in acute respiratory or cardiopulmonary failure often struggle to get oxygen into their bloodstream or expel carbon dioxide out of their bodies, resulting in dangerously low levels of oxygen.
The company added that the Novalung ECMO system pumps and oxygenates a patient's blood, reducing the stress on damaged heart and lungs.
Additionally, the company's Novalung offers an alternative to the need for invasive mechanical ventilation, which can cause additional lung injury. It offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings including intensive care units, operating rooms, cardiac catheterization labs and emergency departments.
In conjunction, the company expects Novalung to be available within the US mid-year 2020.
GSK wins European Commission approval for Shingrix prefilled syringe
Tri-City Cardiology adds new members to care team
GENinCode expands Mexico presence with CARDIO inCode-Score distribution agreement
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
InsiteOne agrees strategic partnerships with ASCEND Cardiovascular and Apollo Enterprise Imaging
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
LivaNova secures higher Medicare reimbursement for VNS Therapy procedures