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HEART AND LUNG THERAPY

Novalung® Heart and Lung Therapy System

Novalung is an extracorporeal membrane
oxygenation (ECMO) system that will transform
how we treat acute respiratory and
cardiopulmonary failure.

 

ASK ABOUT NOVALUNG GET SUPPORT INDICATIONS, SAFETY AND WARNINGS

Insist on Safety. Deliver Accuracy. Choose Novalung.

When treating patients with acute respiratory or cardiopulmonary failure, every choice is critical. Novalung provides extracorporeal circulation and physiologic gas exchange via accurate delivery and safety-focused technology that enables long-term support.

Novalung is a time-sensitive and simple lifesaving solution for your most critical patients. 

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Overview

Novalung’s single integrated platform focuses on improving the delivery, duration, and impact of life-saving care. With advanced technology that oxygenates blood, removes CO2, and helps reduce stress on damaged organs, it is ideal for ECMO-assisted cardiopulmonary resuscitation (ECPR), patients who need assistance weaning from cardiopulmonary bypass (CPB), and extracorporeal carbon dioxide removal (ECCO2R).

Our impressive array of safety features includes a pre-connected standard set, active backup pump, and integrated bubble trap. The system can reduce the need for invasive mechanical ventilation, which, due to the air pressure required, could cause additional lung injury.1

Functions designed to enhance control and monitoring of ECMO therapy provide additional support for multi-organ injuries2 and may optimize survival in cardiac arrest3. These include pressure-limiting flow control, low flow precision, auto-set alarm limits, and visual parameter trending.

Until now, extracorporeal life support (ECLS) systems have only been approved for short-term treatments, which may be insufficient in more urgent situations. As the first ECMO system FDA-cleared for long term use over six hours, it gives your most critical patients what they need most–more time to heal.

DISCOVER KEY FEATURES

Features Focused on Improving Patient Care  

Novalung is a life support device for your critical patients, using simple, yet powerful, features and functions.

  • Intuitive Interface
  • Pressure and Alarm Management 
  • Portable Console
  • Hot Swappable Battery Packs
  • Sensor Box Central Control Unit
  • Powerful Oxygenation
  • Diagonal Pump Design for Minimal Prime Volume
  • Integrated Pressure Sensors

Smart Workflow, Simple Operation

Novalung aims to help you work smarter. Our intuitive interface offers a bright and colorful display, data trending with up to four parameters, and optional hard key navigation.

Pressure and alarm-management functions include a negative pressure limiter, zero flow mode, and bubble and flow alarms.

Redundant hard keys supplement touchscreen controls.

Convenient and Responsive

Novalung offers remarkable flexibility, to support your critically ill patients wherever they receive treatment. This includes intensive care units, operating rooms, cardiac cath labs, and emergency rooms. Two independent hot-swappable battery packs provide up to seven hours of backup power when you need it. This functionality is essential when AC or DC power is not available or during backup operation. The batteries also have direct pump drive connections to provide additional support.

The sensor box, a central control unit, contains connectors for the pressure sensors, flow sensor, and pump drive.

ACCESSORIES

XLungTM Patient Kit

When combined with the innovative XLung Patient Kit, the Novalung system may reduce the dependency for mechanical ventilation by enabling extracorporeal gas exchange. The XLung patient kit puts precision and power in the hands of clinicians, with the following components.

  • The Membrane Lung, with proprietary x.ellence® heparin coating, provides hemocompatibility for long-term applications. Additional features include PMP fiber technology, integrated pressure sensors, and oxygenator with integrated bubble trap.
  • The DP3 Pump offers precise control for low- and high-flow delivery, a diagonal design for minimal prime volume, and innovative coils that aid heat dissipation. An easy-to-switch backup drive is also included.
  • Taking the place of conventional pressure measurement lines, the XLung’s Integrated Pressure Sensors enhance safety and reduce the risk of air aspiration. They require no calibration and connect easily.

  1. Kluge, Stefan et al., "Avoiding Invasive Mechanical Ventilation by Extracorporeal Carbon Dioxide Removal in Patients Failing Noninvasive Ventilation." Intensive Care Medicine 38, no. 10 (October 2012): 1632 -1639. 
  2. Hughes, Ronson et.al., "Extracorporeal Membrane Oxygenation in Traumatic Injury: An Overview of Utility and Indications." InTech (September 2016)
  3. Shin,TG et al., "Extracorporeal Cardiopulmonary Resuscitation in Patients with Inhospital Cardiac Arrest: A Comparison with Conventional Cardiopulmonary Resuscitation." Crit Care Med 39, no. 1 (January 2011): 1 -7.

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. 

© 2021 Fresenius Medical Care. All Rights Reserved. Fresenius Medical Care, the triangle logo, Novalung, XLung, x.ellence, System One, and NxView are trademarks of Fresenius Medical Care Holdings, Inc. or its affiliated companies. All other trademarks are the property of their respective owners. P/N 103880-01 Rev F 08/2021

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