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Shaping the Future
of ECMO Therapy

Global ECMO Experience

Fresenius Medical Care is dedicated to advancing healthcare by providing leading-edge and dependable products to critically ill patients in hospitals worldwide. With a legacy spanning decades, our company has been at the forefront of delivering innovative solutions. Since 2016, Fresenius Medical Care has expanded its mission to include extracorporeal membrane support for patients experiencing acute cardiopulmonary and respiratory failure.

The Novalung® System, an extracorporeal membrane oxygenation (ECMO) device, has emerged as a trusted device for healthcare professionals, including cardiothoracic surgeons, interventional cardiologists, intensivists, emergency medicine physicians, perfusionists, and bedside caregivers such as intensive care unit registered nurses (ICU RNs) and respiratory therapists (RCTs). This simple yet sophisticated system facilitates safe delivery of veno-arterial ECMO (VA ECMO), veno-venous ECMO (VV ECMO), and ECMO-assisted cardiopulmonary resuscitation (ECPR) as well as support, including experienced ECMO clinical educators.

This unwavering commitment to advancing heart and lung therapy underscores Fresenius Medical Care's global mission — to support extracorporeal cardiopulmonary treatments such as CO2 removal and oxygenation.

ECMO Therapy

ECMO is used for cardiac or respiratory failure where conventional management, including cardiopulmonary resuscitation, is not successful. ECMO is a circuit comprised of a draining cannula that drains blood from the body for circulation in the machine and returns to the body through a returning cannula. Traditionally, VA and VV ECMO are used. During this circulation of blood, anticoagulation monitoring is essential to maintain the balance between clotting and bleeding.1
 

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The Novalung System

Fresenius Medical Care’s Product offering includes the Novalung System, the first US Food and Drug Administration–cleared ECMO system (VA, VV, and ECPR) for long-term use for more than 6 hours.2

Product features and support:

  • Safety: Designed to minimize emergent circuit changes
  • Simplicity: Intuitive user interface designed to simplify workflow and save time
  • Portability: Easy transport throughout the hospital
  • Robust supply chain and 24/7 clinical support

 

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Continuous Innovation Is at the Heart of Our Committment to Optimizing Care

x.cellence® Coating

Covalently bonded layers of heparin and albumin designed to provide improved hemocompatibility2

Third-Generation DP3 Pump

Designed to minimize blood contact with impellers and reduce areas of stasis in the pump head2

A Simple User-Interface

Includes single-touch access, real-time trending of pressures (p1, p2, p3), Delta P, Speed, Flow and Power, designed to heighten bedside awareness, enabling RNs, RTs, and perfusionists to proactively manage the circuit, compared to reacting in the heat of the moment2

Clinical data supporting the FDA's clearance of the Novalung System comes from a 148-patient registry (Regensburg Registry), including3:

100 VV Patients3

80%

survivability on ECMO
for VV patients

41%

of VV patients were
on ECMO >9 days

65
DAYS

was the maximum ECMO
duration for VV patients

10.7
DAYS

was the average time
on ECMO

48 VA Patients3

69%

survivability on ECMO
for VA patients

17%

of VA patients were
on ECMO >9 days

47
DAYS

was the maximum ECMO
duration for VA patients

6.4
DAYS

was the average time
on ECMO

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References

  1. Vyas A, Bishop MA. Extracorporeal Membrane Oxygenation in Adults. In: StatPearls. Treasure Island (FL): StatPearls Publishing; June 21, 2023.
  2. Data on File.
  3. X-Lung Kit. Instructions for Use. Fresenius Medical Care North America; 2019. Item no: 8200733. Version: US_003_2019_08.


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. The Indications for Use for this device can be found at https://fmcna.com/products/indications-safety-and-warnings.

© 2024 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, Novalung, XLung, and x.ellence are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. 105688-01 Rev A 02/2024