Medical Device News Magazine

Novalung ® for Treatment of Acute Respiratory and Cardiopulmonary Failure Receives FDA Clearance

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

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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 provide the lifesaving support needed for patients in critical conditions.

FMCNA expects Novalung to be available within the U.S. mid-year 2020. More on this here.

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.

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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