Novalung company info and contacts
Solutions for Lung Failure
Already today reality: Awake patient with iLA Membrane Ventilator®
Contact info
Novalung GmbH
Egerten 3
D-74388 Talheim
Phone +49 7133 90 11 0
Fax +49 7133 90 11 299
email: info@novalung.com
click to offical website for Novalung.com
Imagine a world in which many patients in the Intensive Care Unit are not placed in an artifical coma so that they can tolerate mechanical ventilation, but rather experience their treatment while awake and breathing easily and spontaneously. Patients who can communicate, eat and drink. This can become reality when a Novalung extracorporeal Membrane Ventilator is used to support the breathing process.
Novalung‘s vision and mission are the creation of new Solutions for Lung Failure using artificial lungs that breathe for the patient outside the body. They thus give the lung Time to Heal® and improve the patient’s quality of life. The iLA Membrane Ventilator® is the first in a series of products that open the door for physicians and nurses to this vision.
Novalung works continuously with its clinical partners to make this vision a reality. We invite you to join us and look forward to an active dialogue!
Saturday, September 4, 2010
Friday, September 3, 2010
$5,000 device by Novalung device
Owen Stark in July when he used an artificial lung. He was the youngest patient on the machine. (St. Louis Children's Hospital)
When Owen Stark came to St. Louis Children's Hospital in June with severe lung disease, he had just a few days to live and even fewer options for treatment.
Owen, 2, had severe pulmonary hypertension, meaning the blood vessels in his lungs were so constricted they could barely carry blood. He had to go on life support to keep his heart and lungs functioning. Medications for the disease can take weeks or months to improve a patient's condition. Waiting for a suitable lung transplant can add another two to six months.
"Transplant or medication, both options take time, and he didn't have time," said Dr. Mark Grady, Owen's cardiologist.
A surgeon on the team had heard of an artificial lung used in Europe and Canada, but not approved for long-term use in the United States. The hospital appealed for a compassionate use exemption, which was granted in about three days by the Food and Drug Administration.
Owen's parents, of Eldon, Mo., were shocked by the rapid deterioration of the boy who seemed energetic and healthy just hours before he was hospitalized. They agreed to the experimental treatment.
"We were really nervous about it, but at that point he had no other options to live." Justin Stark said.
Surgeons implanted Owen with the Novalung device, a small box with two tubes on either side that are attached to the heart. Blood goes through one tube into the box, where oxygen is added and carbon dioxide is removed, and then the blood returns to the heart through the other tube.
Hospital officials were eager to promote the story to the public, as the first time the $5,000 device had been used on a patient in the U.S.
But Owen's doctors resisted public and media attention until they knew Owen wasn't going to die.
After about three weeks on the device, Owen was feeling pretty vigorous, and kicked one of the tubes loose. Somehow a blood clot dislodged and the little boy suffered a stroke.
The doctors decided to remove the device, and Owen has been breathing on his own ever since.
Owen lost mobility on his right side and his speech was affected by the stroke. He's in therapy and still takes three drugs for lung function.
Doctors say they're in a wait-and-see mode. Owen's lungs could stop functioning again and he might still need a lung transplant. Or he could leave the hospital and go home in a month.
"His prognosis is guarded," Grady said. "He's clearly shown a good response to the meds. Only time will tell whether he'll stabilize."
When Owen Stark came to St. Louis Children's Hospital in June with severe lung disease, he had just a few days to live and even fewer options for treatment.
Owen, 2, had severe pulmonary hypertension, meaning the blood vessels in his lungs were so constricted they could barely carry blood. He had to go on life support to keep his heart and lungs functioning. Medications for the disease can take weeks or months to improve a patient's condition. Waiting for a suitable lung transplant can add another two to six months.
"Transplant or medication, both options take time, and he didn't have time," said Dr. Mark Grady, Owen's cardiologist.
A surgeon on the team had heard of an artificial lung used in Europe and Canada, but not approved for long-term use in the United States. The hospital appealed for a compassionate use exemption, which was granted in about three days by the Food and Drug Administration.
Owen's parents, of Eldon, Mo., were shocked by the rapid deterioration of the boy who seemed energetic and healthy just hours before he was hospitalized. They agreed to the experimental treatment.
"We were really nervous about it, but at that point he had no other options to live." Justin Stark said.
Surgeons implanted Owen with the Novalung device, a small box with two tubes on either side that are attached to the heart. Blood goes through one tube into the box, where oxygen is added and carbon dioxide is removed, and then the blood returns to the heart through the other tube.
Hospital officials were eager to promote the story to the public, as the first time the $5,000 device had been used on a patient in the U.S.
But Owen's doctors resisted public and media attention until they knew Owen wasn't going to die.
After about three weeks on the device, Owen was feeling pretty vigorous, and kicked one of the tubes loose. Somehow a blood clot dislodged and the little boy suffered a stroke.
The doctors decided to remove the device, and Owen has been breathing on his own ever since.
Owen lost mobility on his right side and his speech was affected by the stroke. He's in therapy and still takes three drugs for lung function.
Doctors say they're in a wait-and-see mode. Owen's lungs could stop functioning again and he might still need a lung transplant. Or he could leave the hospital and go home in a month.
"His prognosis is guarded," Grady said. "He's clearly shown a good response to the meds. Only time will tell whether he'll stabilize."
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
“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
Thursday, September 2, 2010
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.
First Working Replacement Lung Created in Lab
First Working Replacement Lung Created in Lab
An engineered lung (bottom) worked when implanted into a rat (top).
For the first time scientists have reconstructed working lungs in the lab and transplanted them into a living animal. The achievement is a breakthrough in biomedical engineering that could lead to replacement lungs for humans in the near future, experts say.
that's vulnerable to tissue rejection.
In a new study, researchers took lungs from a living rat and used detergents to remove lung cells and blood vessels, revealing the organ's underlying matrix. This lung "skeleton"—made of flexible proteins, sugars, and other chemicals—consists of a branching network that divides more than 20 times into smaller and smaller structures. (See an interactive graphic of lung structure.)
The researchers placed these "decellularized" lungs into a bioreactor, a machine filled with a slurry containing different types of lung cells extracted from rat fetuses. Within several days, the fetal cells naturally attached to the lung matrix and formed a functional lung.
"By and large, the correct subsets of cells went to their correct anatomical locations," explained study leader Laura Niklason, a biomedical engineer at Yale University. "It appears that the lung matrix has cues, or 'zip codes,' that tell the cells where to land."
When the team implanted the engineered lungs into an adult rat for short periods of time—between 45 minutes and two hours—the lungs exchanged oxygen and carbon dioxide in the same way as natural lungs.
"Leap Forward"
By using a natural lung matrix, Niklason's team has avoided one of the biggest hurdles of lung-regeneration attempts—finding a suitable "scaffold" for lung cells to attach to.
Because manufacturing techniques cannot yet replicate nature's complex design, attempts to create synthetic scaffolds have been unsuccessful. Niklason spent several years trying to create a synthetic lung scaffold, but in the end concluded it was too difficult.
"I decided I couldn't do it, and probably nobody else could either," she said.
The new research represents a "real leap forward" in lung regeneration, said Peter Lelkes, a biomedical engineer at Drexel University in Philadelphia.
"People have engineered organs such as bone and cartilage before, but by comparison to the lung, these are all kids' games," added Lelkes, who was not involved with the study.
Stem Cell Hurdle
Niklason estimates it will be about 20 to 25 years before her team's technique can be used in humans.
That's because a few technical and scientific challenges remain.
Chief among these is finding ways of creating stem cells—which can transform into any other type of cell—from patients with lung disease. No techniques currently exist for creating such cells, which would carry no risk of immune rejection.
(Related: "Liposuction Fat Turned Into Stem Cells, Study Says.")
"The stem cell issue," Niklason said, "is really the big fundamental scientific hurdle."
The research is detailed in this week's issue of the journal Science
Ker Than for National Geographic News
published June 24, 2010
see more at news nationalgeographic com news replacement lab
An engineered lung (bottom) worked when implanted into a rat (top).
For the first time scientists have reconstructed working lungs in the lab and transplanted them into a living animal. The achievement is a breakthrough in biomedical engineering that could lead to replacement lungs for humans in the near future, experts say.
that's vulnerable to tissue rejection.
In a new study, researchers took lungs from a living rat and used detergents to remove lung cells and blood vessels, revealing the organ's underlying matrix. This lung "skeleton"—made of flexible proteins, sugars, and other chemicals—consists of a branching network that divides more than 20 times into smaller and smaller structures. (See an interactive graphic of lung structure.)
The researchers placed these "decellularized" lungs into a bioreactor, a machine filled with a slurry containing different types of lung cells extracted from rat fetuses. Within several days, the fetal cells naturally attached to the lung matrix and formed a functional lung.
"By and large, the correct subsets of cells went to their correct anatomical locations," explained study leader Laura Niklason, a biomedical engineer at Yale University. "It appears that the lung matrix has cues, or 'zip codes,' that tell the cells where to land."
When the team implanted the engineered lungs into an adult rat for short periods of time—between 45 minutes and two hours—the lungs exchanged oxygen and carbon dioxide in the same way as natural lungs.
"Leap Forward"
By using a natural lung matrix, Niklason's team has avoided one of the biggest hurdles of lung-regeneration attempts—finding a suitable "scaffold" for lung cells to attach to.
Because manufacturing techniques cannot yet replicate nature's complex design, attempts to create synthetic scaffolds have been unsuccessful. Niklason spent several years trying to create a synthetic lung scaffold, but in the end concluded it was too difficult.
"I decided I couldn't do it, and probably nobody else could either," she said.
The new research represents a "real leap forward" in lung regeneration, said Peter Lelkes, a biomedical engineer at Drexel University in Philadelphia.
"People have engineered organs such as bone and cartilage before, but by comparison to the lung, these are all kids' games," added Lelkes, who was not involved with the study.
Stem Cell Hurdle
Niklason estimates it will be about 20 to 25 years before her team's technique can be used in humans.
That's because a few technical and scientific challenges remain.
Chief among these is finding ways of creating stem cells—which can transform into any other type of cell—from patients with lung disease. No techniques currently exist for creating such cells, which would carry no risk of immune rejection.
(Related: "Liposuction Fat Turned Into Stem Cells, Study Says.")
"The stem cell issue," Niklason said, "is really the big fundamental scientific hurdle."
The research is detailed in this week's issue of the journal Science
Ker Than for National Geographic News
published June 24, 2010
see more at news nationalgeographic com news replacement lab
Wednesday, September 1, 2010
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
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
Artificial lungs breathe new hope for transplants
Artificial lungs breathe new hope for transplants
First it was the heart, then the liver - now two research teams have grown artificial lungs that function in rats. It is hoped that a similar technique could one day engineer donor organs for humans.
A lung transplant is the only option for people with terminal lung disease caused by conditions like cystic fibrosis or chronic obstructive pulmonary disease. But donor organs are in short supply, and rejection is likely even if a lung becomes available.
In a quest to solve both problems, teams from Harvard Medical School in Boston and Yale University, working separately, stripped donor rat lungs of their original tissue by exposing them to a mild detergent. The teams then repopulated the remaining "scaffold" of connective tissue with foetal stem cells and incubated the organs in nutrients to help them grow.
The new lungs were then "replumbed" into rat recipients. The regenerated lungs resembled native lungs in size and oxygenated the recipient's blood for up to six hours, after which oedema - accumulation of fluid within the lung - and capillary leakage occurred.
cick to see the site newscientist.com artificial lungs breathe new hope
First it was the heart, then the liver - now two research teams have grown artificial lungs that function in rats. It is hoped that a similar technique could one day engineer donor organs for humans.
A lung transplant is the only option for people with terminal lung disease caused by conditions like cystic fibrosis or chronic obstructive pulmonary disease. But donor organs are in short supply, and rejection is likely even if a lung becomes available.
In a quest to solve both problems, teams from Harvard Medical School in Boston and Yale University, working separately, stripped donor rat lungs of their original tissue by exposing them to a mild detergent. The teams then repopulated the remaining "scaffold" of connective tissue with foetal stem cells and incubated the organs in nutrients to help them grow.
The new lungs were then "replumbed" into rat recipients. The regenerated lungs resembled native lungs in size and oxygenated the recipient's blood for up to six hours, after which oedema - accumulation of fluid within the lung - and capillary leakage occurred.
cick to see the site newscientist.com artificial lungs breathe new hope
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