FDA Clears Novalung for Treatment of Acute Respiratory and Cardiopulmonary Failure

FDA Clears Novalung to Treat Acute Cardiopulmonary Failure

Fresenius Medical Care North America Announces First Extracorporeal Membrane Oxygenation (ECMO) System Cleared for Long-Term Use

WALTHAM, Mass. – February 24, 2020 – Fresenius Medical Care North America (FMCNA) today announced that the U.S. Food and Drug Administration (FDA) has cleared Novalung®, a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure. Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support.

“Novalung is a critical leap forward in providing heart and lung support therapy for a longer duration than ever available before,” said Mark Costanzo, President of Renal Therapies Group, the technologies and pharmaceuticals division of FMCNA. “We’ve applied our leadership and technical expertise in renal medical devices to elevate standards for acute respiratory and cardiopulmonary failure treatments and technologies. We’re proud to broaden our care offerings to provide new therapies for patients with acute cardiopulmonary conditions.”

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. This acute low oxygen state can result from a wide range of conditions. Recent research has shown a significant increase in the use of ECMO with evidence of improved survival rates and no increase in hospitalization costs.1

The Novalung ECMO system pumps and oxygenates a patient’s blood, reducing the stress on damaged heart and lungs. Additionally, Novalung offers an alternative to the need for invasive mechanical ventilation, which can cause additional lung injury as a result of the air pressure required. Novalung offers a portable therapy solution designed to improve clinical outcomes and accommodate various clinical care settings such as intensive care units, operating rooms, cardiac catheterization labs, and emergency departments.  

“A long-term, effective ECMO solution gives critically-ill patients the time and support needed to heal,” said Dr. Robert Bartlett, Professor Emeritus, Section of General Surgery, Division of Acute Care Surgery, University of Michigan School of Medicine. “The system’s pressure sensor technology ensures continuous monitoring and accurate flow control of each patient’s blood, allowing the care team the flexibility needed to treat the underlying health issues.”

The use of Novalung as an ECMO device for critical care has several benefits, including minimizing the need for invasive ventilation, the ability to provide support after multi-organ injuries, and better survival outcomes for patients in cardiac arrest. This integrated heart and lung therapy platform provides the lifesaving support needed for patients in critical conditions.

FMCNA expects Novalung to be available within the U.S. mid-year 2020. To learn more, please visit fmcna.com/novalung.

1 Extracorporeal membrane oxygenation use has increased by 433% in adults in the United States from 2006 to 2011. ASAIO J. 2015 Jan-Feb;61(1):31-6. doi: 10.1097/MAT.0000000000000160.

INDICATIONS FOR USE
The Novalung System is indicated for long-term (>6 hours) respiratory/cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. These may include:

• Failure to wean from cardiopulmonary bypass following cardiac surgery in adult patients
• ECMO-assisted cardiopulmonary resuscitation in adults

Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.

Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications, side effects, and precautions, see full package labeling at www.fmcna.com.

About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com.

Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.

Media Contact:
Fresenius Medical Care North America
Brad Puffer
Director of Public Relations
Brad.Puffer@fmc-na.com
(781) 699-3331