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On February 21, 2020, the U.S. Food and Drug Administration (FDA) cleared Novalung®, a heart and lung support system for the treatment of acute respiratory or cardiopulmonary failure in adults. Novalung is the first extracorporeal membrane oxygenation (ECMO) system to be cleared for more than six hours of use as extracorporeal life support.
Robert Bartlett, MD, is currently a Professor of Surgery in the Division of Acute Care Surgery at the University of Michigan Medical Center. Now a retired surgeon, Dr. Bartlett proved instrumental in the creation and advancement of ECMO treatment.
In this Q&A, Dr. Bartlett shares his thoughts on the FDA’s clearance of Novalung, and how ECMO devices like this one are helping to save patient lives.
Q: In your own words, how would you describe ECMO treatments? How did you become involved in this field?
RB: About 50 years ago, when I was a practicing surgeon, I had a lot of patients experience heart and lung failure during general and cardiothoracic surgery. For me, it was personal. I wanted to find a way to save my patients, so I worked with colleagues to create an ECMO treatment.
ECMO treatments like Novalung oxygenate a patient’s blood through an artificial lung and circulate oxygen back into the bloodstream, taking over the function of the heart and lungs. Patients in heart and lung failure are supported by an ECMO device until their organs stabilize.
Q: How is Novalung different from existing ECMO treatments?
RB: While there are only a few ECMO machines, the general concept of Novalung is not too different from other ECMO treatments. It functions similarly to oxygenate a patient’s blood.
However, the indication provided for Novalung is for ECMO with cardiopulmonary resuscitation (CPR) for long term use, which would allow physicians to use this device for more than six hours. This would make it the first device in the U.S. that is cleared for long-term use.
Q: What are the biggest challenges with ECMO treatments that the industry is facing?
RB: Taking a step back to the industry level, the biggest challenge with ECMO is that the concept is simple, but its use can be complex. Many top intensive care doctors are still learning how to effectively use ECMO in practice.
Our largest hurdle for the next 10 years is education on and awareness of ECMO treatments. That’s why I started the Extracorporeal Life Support Organization (ELSO), an international organization that works with over 600 major medical centers worldwide to explain the use of ECMOs and provide educational materials to those that need to know more about it.
Q: Where do you think this technology could be used in the future?
RB: On the application side, ECMO technologies are currently being used for heart and lung failure. The future growth areas for ECMO devices are in the use cases. My personal goal, and the reason why I started the ELSO, is to educate physicians about the use of ECMOs and demonstrate ways to use this technology.
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:
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.
© 2020 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, and Novalung are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 104136-01 Rev A 03/2020