Info on the NovaLung company and their lung products

Info on the NovaLung company and their lung products

Novalung GmbH locations

Highly qualified precision production processes in medtech manufacturing

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Solutions for Lung Failure

 Novalung‘s mission is to create new solutions for the treatment of lung failure with innovative artificial lungs that “breathe” outside the patient’s body. The pioneering task is to work with leading clinicians around the world to develop new therapies to replace damaging invasive mechanical ventilation.

Novalung GmbH was founded in Hechingen (Baden-Württemberg, Germany) in 2003 through the fusion of leading German and American technologies in the field of artificial lungs and is now active throughout the world. From the outset Novalung has focused on high-quality development and production “Made in Germany“.  Cutting-edge technologies are employed in Novalung’s medtech production facility in the manufacture in particular of the iLA Membrane Ventilator® and NovaPort® vascular access cannulas, both of which have been used to help treat thousands of patients.

click to the NovaLung web site on lungs

A artificial lung in humans ??

First experience with a paracorporeal artificial lung in humans.

Camboni D, Philipp A, Arlt M, Pfeiffer M, Hilker M, Schmid C.

Source

Departments of Cardiothoracic Surgery, University Hospital Regensburg, Germany. dcamboni@arcor.de

Abstract

Lung transplantation is the only treatment option for patients suffering form end-stage respiratory failure. To date, no mechanical device is available to support patients on the waiting list up to months. Here, we summarize our experience with our first two patients, who were supported with a paracorporeal artificial lung (PAL) placed in parallel to the pulmonary circulation with connection to the pulmonary artery and to the left atrium. A low resistance membrane oxygenator (iLA, Novalung, Hirrlingen, Germany) was attached in both patients. Our first patient suffering from a pulmonary veno-occlusive disease was supported for 18 days until he died due to severe sepsis. Our second patient with a primary pulmonary hypertension of unknown origin was supported 62 days followed by successful lung transplantation.
 In conclusion, the experience obtained with these first two patients under PAL encourages further studies and introduction of this promising concept into clinical practice.

PMID: 19282751 [PubMed - indexed

click to see lung more info at ncbi nlm.nih.gov

gas exchange in the artificial lung by NovaLung /Ila

Gas exchange via artificial alveoles

A hollow-fiber membrane is responsible for gas exchange in the artificial lung, which measures only 14 by 14 cm, supporting or even replacing mechanical ventilation. The iLA Membrane Ventilator® is connected to the patient via two NovaPort® femoral cannulas in an arterio-venous circuit. The absence of a mechanical blood pump reduces the risk of inflammatory reactions.

see moe on this new lung Ila product

Novalung receives CE mark

Novalung receives CE mark for iLA activve With the new all-rounder for extrapulmonary lung support Novalung GmbH is the only company worldwide offering the complete portfolio for both pumpless and pump-driven lung support.

Novalung announces receiving CE mark approval for their new pump-driven iLA activve® lung support system. It will be launched in Europe with immediate effect.

Respiratory support with iLA activve® enables a treatment environment with awake, mobile patients instead of sedated patients on invasive mechanical ventilation that causes further damage to the lung and other organs. The iLA activve® is thus a major step towards replacing invasive mechanical ventilation.

Different patient populations and types of lung failure place varying demands on optimal respiratory support. To cover all extrapulmonary support needs with one system platform, the iLA activve® has been developed as a flexible all-rounder. The iLA activve® with veno-venous cannulation covers the full range of respiratory support, from highly effective carbon dioxide elimination to complete oxygenation. Core elements are the iLA Membrane Ventilator®, the only gas exchanger specifically designed for long-term respiratory support, and the iLA activve® pump which surpasses all previously available blood pumps in its performance, broad range of blood flow, and blood protection characteristics.

The iLA activve® system has been specifically configured to allow patients to move about during respiratory support. Therefore all necessary components are mounted on an easily movable trolley. Furthermore the iLA Membrane Ventilator® and the iLA activve® pump are height-adjustable via a quick-release handle. “This allows physicians, respiratory therapists and nurses to adjust the system to the patient’s individual needs, whether the patient is in bed, sits up or even walks”, explains Dr. Georg Matheis, Managing Director of Novalung.

The range of applications of the iLA Membrane Ventilator® technology has broadened substantially. While severe acute lunge failure (ARDS) was the typical indication in the early days, today exacerbations of chronic lung disease (COPD) comprise a growing application of the iLA Membrane Ventilator®. Novalung will launch several additional products for the iLA activve® platform throughout this year.

click for official Novalung

Novalung and Medos start cooperation

Due to the acquisition of Medos Medizintechnik AG by the private equity fund Zukunftsfonds Heilbronn (“Future Fund of Heilbronn”) the company will cooperate closely in the future with Novalung GmbH, which is expected to strengthen both medical device companies.

The Zukunftsfonds Heilbronn (zfhn) announced that it has acquired Medos Medizintechnik AG from Ventizz Capital Partners Advisory AG. The purchase agreement was signed on January 7, 2011. With this acquisition medical device technology has become the most important sector for the private equity fund. Thomas Villinger, Managing Director of the zfhn, explained the decision behind this acquisition: ”The medical device sector is characterized by solid growth and is independent of economic cycles.“ He noted further that “Medos and Novalung are technological leaders is different markets, namely cardiac support and lung support. Their innovative technologies complement one another extremely well, and a close cooperation will enable even better utilization and speed up further developments.“

Dr. Volker Hamm, who has been named to join the Medos Management Board, noted with pleasure: “We are very happy about this development. Novalungs excellent market know-how in the field of lung support will provide a much broader customer base for our high-tech products.“ Hamm also noted that Christian Palme will join Thomas Villinger on the Supervisory Board of Medos. The Medos facilities in Stolberg und Radeberg will continue their operations after the acquisition.

Dr. Georg Matheis, Managing Director of Novalung GmbH since its founding eight years ago, emphasized that Novalung, after thousands of treatments using the company’s artificial lung, the iLA Membrane Ventilator®, has firmly established itself. “The innovative therapy for the treatment of lung failure without invasive mechanical ventilation is now well accepted” the former cardiothoracic surgeon noted. ”In order to further expand our market leadership as the pioneering company in this field, we will develop a full product portfolio in 2011. With the cooperation with Medos this can be accomplished more quickly than we originally expected.“ Matheis also pointed to the newest member of Novalung’s executive management team, Josef Bogenschütz, who left medical device company Maquet and join Novalung just a few weeks earlier. “In addition to strong leadership, Josef Bogenschütz brings with him great expertise in the development and manufacturing of artificial lungs. With him on board we are ideally positioned to aggressively develop additional innovative solutions for the replacement of invasive mechanical ventilation. Together, and with the support of our clinical partners, we will realize the vision of increasingly avoiding the damage of invasive mechanical ventilation.“

Bogenschütz, who most recently drove the successful growth of Maquet Cardiopulmonary AG as President and CEO, is equally optimistic concerning the expansion of the zfhn portfolio. ”I am pleased that this new cooperation provides so many areas of synergy for both companies. We will jointly leverage our know-how in the high-end cleanroom manufacturing of artificial lungs to further optimize our manufacturing efficiencies.“ He also presented Novalungs core strategy to intensify the company’s research and development activities and to further expand sales in the core markets in Europe and the USA.

see more info on this external lung device
http://www.openpr.com/news/159889/Novalung-and-Medos-start-cooperation.html

new Manager at Novalung GmbH a artificial lungs manufacturer

Novalung GmbH prepares for further growth with former Maquet CEO.

As of January 1, 2011, Josef Bogenschütz and Dr. Georg Matheis are joint Managing Directors of Novalung GmbH. Bogenschütz will be specifically responsible for Research & Development, Manufacturing, Quality Management and Finance. This addition underscores the company’s focus on the ongoing and efficient expansion of its portfolio of innovative products designed to replace invasive mechanical ventilation. Nicholas L. Strout remains responsible for the growth of Novalung’s sales activities.

Dr. Georg Matheis, who has been Managing Director of Novalung since its founding in 2003, commented: “I’m truly looking forward to working with Josef Bogenschütz, who brings with him extensive expertise in our core business, the development and manufacturing of artificial lungs.“

Development of the Artificial Lung Zwischenberger

Zwischenberger- Development of the Artificial Lung

Sherbrooke man survives rare lung surgery

Sherbrooke man survives rare lung surgery


Thu Jul 8, 4:55 PM

Doctors in Sherbrooke, Que. are hopeful that a man suffering from severe pneumonia may have a fighting chance after surviving a rare lung procedure.

The man is believed to be the first in Quebec to have survived the surgery to attach an external artificial lung, known as a Novalung, to his leg.

The device is meant to perform some of the functions of a normal lung, including clearing the body of carbon dioxide and pumping a small amount of oxygen into the body through the arteries and veins in the leg.

The patients involved in the first two surgeries in Quebec did not survive the procedure.


Doctors said the device can only operate for up to 29 days.

It´s going to be there for a short period of time, after a while we´re going to take it out. The device is just to let the lung recover from the pneumonia, said Dr. Marco Sirois, a thoracic surgeon with Sherbrooke University Health Centre.

The 47-year old patient, who cannot be identified due to privacy regulations, is still in critical condition. His daughters said they remain optimistic, despite the fact that their father is still seriously ill.


"Were trying to stay realistic," said Noémie, one of the patient´s daughters.
"But the surgery has given us hope, said the other daughter, Jessica.

The surgery is so rare in Quebec that doctors in Sherbrooke sought the help of a specialist from Toronto, who was flown in from Montreal in a Quebec provincial police helicopter.

The Novalung is also sometimes used to help patients who are waiting for a lung transplant.

see more info on the novalung

NovaLung on an emergency basis

Currently, the Novalung ILA is listed as a “Class III – Premarket Approval” device by the Food and Drug Administration, the category with the most stringent approval requirements, according to the FDA’s Web database.

“When an Army doctor wants to use the NovaLung on an emergency basis, we ask the manufacturer, NovaLung U.S., to notify the FDA of the device’s use under the FDA NovaLung Investigational Device Exemption requirements,” wrote Cynthia Vaughn, a spokeswoman for the Army surgeon general’s office, in an e-mail to Stars and Stripes.


But despite any after-the-fact scrutiny or investigations made into medical staff over use of the device last spring, doctors said they were simply doing what they could do to save wounded servicemembers. “We tried to do what we would want someone to do if it was our own son, daughter, or spouse; each and every life was precious,” Col. Rhonda Cornum, commander of Landstuhl at the time Mishoe, Phillip and Wong were hurt, wrote in an e-mail to Stars and Stripes.

Doctors did — and continue to do — everything they can to save injured servicemembers, said Col. Mark Ivey, a pulmonary critical care specialist who assisted Boylston with both Phillip and Wong. “We can and will do whatever it takes to return [servicemembers] home in as good of shape as possible,” Ivey said.

And though her son has no recollection of being attached to the Novalung ILA, Julie Mishoe said she knows it helped save his life, and was glad that its success with Joshua may have helped make it available to other servicemembers. “It’s just wonderful to know that machine has been used to save other people’s lives,” she said.


click to read more at stripes.com news lung device German NovaLung

drawing of the Novalung, made in Germany

The Novalung ILA aids the lungs by drawing off carbon dioxide from the blood and infusing cells with oxygen. Inserted by catheters into the major arteries in the thighs, it relies on the patient’s heartbeat to pump blood out of one leg, across the special membrane that performs the transfer and back into the body through the other leg.

NovaLung in use with a 2 year old in Missouri

NovaLung in use with a 2 year old in Missouri

Toddler Is World’s Youngest Recipient of Artificial Lung


With the help of German-made NovaLung, 2-year-old Missourian Owen Stark is breathing easily.

When toddler Owen Stark's heart stopped beating not once, but 10 times, his parents thought they would lose him forever. Having been unsuccessful in waiting for a lung donor, they agreed to try an artificial lung device — with successful results.

It was during a shopping trip that the previously healthy 2-year-old collapsed near his Missouri home and was rushed to hospital, unable to breathe, reports Britain's Daily Mail. Diagnosed with idiopathic pulmonary hypertension (high blood pressure in the lungs), he was put on a heart/lung bypass machine at St Louis Children's Hospital while the search for a suitable donor began.

Patients can only be kept on a bypass machine for a limited time before it causes irreversible damage, so time was running out. His parents made the brave decision to try something new: a German-built artificial lung device, called NovaLung. It was the first time a patient as young as their son had been fitted with the device.

Placed outside the body, the little white box is attached by two tubes removing carbon dioxide outside the human lung and perfused with blood by the heart like a natural organ. Doctors have been amazed by Stark's response to his sessions on the machine. Pediatric cardiologist at the hospital, Dr. Mark Grady said, "This absolutely saved his life. He could be going home within a month, which we never ever thought would be possible."

Expected to lead a relatively long and happy life thanks to his new treatment, Stark's parents couldn't be happier. Owen's mother Tonya Stark added, "His life expectancy has gone from a few days to a few weeks and now years — it's a miracle."

By Monique Jessen
 September 1, 2010


toddler gets the Novalung artificial lung, click for more info