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Clinical Trial Opens for 3D-Printed Device Treating Infant Airway Condition
Table of Contents
- Clinical Trial Opens for 3D-Printed Device Treating Infant Airway Condition
- The Promise of 3D-Printed Airway Splints
- Leading the charge: Richard ohye, M.D.
- Understanding Tracheobronchomalacia
- A Decade of Innovation
- Materialise: A Key Partner
- 3D-Printed Hope: Revolutionizing Infant Airway Treatment with bioresorbable Splints
- 3D-Printed Hope: Revolutionizing Infant Airway Treatment with Bioresorbable Splints
A clinical trial, a collaboration between Michigan Medicine and Materialise, is underway to evaluate 3D-printed bioresorbable devices designed to treat infants suffering from tracheobronchomalacia, a rare and life-threatening airway condition. The trial, which began in January, represents a significant stride toward securing full Food and Drug Management (FDA) approval for these innovative splints. These devices aim to provide crucial support to the airways of infants grappling with the most severe forms of this debilitating disease, offering a potential alternative to reliance on ventilators.
The Promise of 3D-Printed Airway Splints
Tracheobronchomalacia, a condition characterized by the collapse of the airway, poses severe breathing difficulties and can be fatal in its most acute manifestations. Currently, many infants with this condition depend on ventilators to sustain their breathing. For over a decade, teams at university of Michigan Health have been granted expanded access approval from the FDA to utilize a pioneering 3D-printed bioresorbable airway splint on a case-by-case basis. This emergency and compassionate use has offered a lifeline to children, but access has remained limited.
Now, researchers at Michigan Medicine and Materialise, a 3D printing manufacturing company, are collaborating to broaden the availability of this treatment. The clinical trial is designed to rigorously assess the safety and efficacy of the device, paving the way for wider adoption.
Leading the charge: Richard ohye, M.D.
Richard Ohye, M.D., a pediatric heart surgeon at U-M Health C.S. Mott Children’s Hospital, serves as the trialS principal investigator and leads the surgical implantation of the device. He emphasized the importance of this research, stating:
We have established a process that allows us to offer the customized airway splint as a last resort treatment for certain children with no other options but we need more research to make it available on a wider scale.
richard Ohye, M.D., U-M Health C.S. mott Children’s Hospital
The research teams plan to enroll 35 infants in the eight-year study. These infants will be recruited from Mott and four other children’s hospitals across the country. Materialise will be responsible for producing the devices used in the trial.
Understanding Tracheobronchomalacia
Tracheobronchomalacia arises when the cartilage in the trachea or mainstem bronchi develops abnormally. The severity of the condition varies significantly. While most children experience mild symptoms that resolve by age 3 as their tracheal cartilage strengthens, a subset faces severe and debilitating consequences.
Glenn Green,M.D., an otolaryngology surgeon at Mott, expressed his frustration with the limited treatment options available for children with the most severe forms of the condition. He noted:
We needed a revolutionary innovation to give these babies a chance to survive.
Glenn Green, M.D., Mott otolaryngology surgeon
A Decade of Innovation
Over a decade ago, Dr. Green collaborated with Scott Hollister, Ph.D., a former professor of biomedical engineering at U-M, to develop a biodegradable scaffolding. This scaffolding could be designed and manufactured into a tracheal splint tailored to each patient’s unique anatomy.
This University of Michigan-developed device is attached to the outer side of the trachea or mainstem bronchi. its purpose is to maintain an open airway and prevent collapse. Notably, it was the first 3D implant created for children, designed to grow with the patient and eventually be safely resorbed by the body.
The first triumphant implantation of the tracheal splint occurred in 2012, saving the life of a three-month-old infant with a severe case of tracheobronchomalacia. The outcome was documented in a New England Journal of Medicine report. With support from the Michigan Institute for Clinical and Health Research (MICHR), Green and his colleagues secured emergency approval to use the bioresorbable scaffolding through collaboration with the FDA, Institutional Review Board, and hospital administration. Since then, it has been used in more then 40 children at Mott.
Materialise: A Key Partner
MICHR, Michigan medicine, and Materialise have collaborated to secure approval for the 3D-printed bioresorbable devices to be used in the clinical trial. this trial represents the next crucial step toward FDA approval for treating children with this life-threatening condition.
materialise, a large 3D-printing company based in Belgium, will print the devices throughout the trial. The company has a long history of pioneering medical 3D printing applications.With over three decades of experience in developing medical solutions, Materialise operates manufacturing facilities for these bioresorbable splints in Ann Arbor. The company produces 280,000 personalized 3D-printed instruments and implants annually, including 160,000 for the U.S. market.
Colleen Wivell, Director of Clinical Engineering at Materialise, highlighted the transformative impact of 3D printing in healthcare:
The advent of technologies such as 3D printing and advanced visualization techniques has transformed patient-specific care. Surgeons increasingly adopt 3D printing as part of their surgical workflow to bring personalized care to patients, improving healthcare and reducing costs overall. We’re so pleased to support this life-saving treatment and look forward to continuing to impact these children and their families.
Colleen Wivell, Director of Clinical Engineering at Materialise
3D-Printed Hope: Revolutionizing Infant Airway Treatment with bioresorbable Splints
Is it possible to imagine a future where life-threatening airway conditions in infants are treated with personalized, dissolvable 3D-printed devices? The answer, thanks to groundbreaking research, is a resounding yes.
Interviewer: Dr. Anya Sharma, a leading pediatric pulmonologist, welcome to World Today News.Your expertise in pediatric respiratory diseases is highly respected. let’s delve into the recent clinical trial focusing on 3D-printed bioresorbable airway splints for infants with tracheobronchomalacia. Can you explain this condition in simple terms for our readers?
Dr. Sharma: Tracheobronchomalacia, or TBM, is a condition where the cartilage supporting the trachea (windpipe) and bronchi (main airways) is weak or underdeveloped. This weakness causes the airways to collapse during breathing, leading to significant breathing difficulties – wheezing, shortness of breath, and even life-threatening respiratory distress in severe cases. In essence, the airway isn’t rigid enough to stay open properly. It is indeed especially challenging in infants as they are entirely reliant on effective airway function. Many infants with severe TBM depend on ventilators for support.
Interviewer: The clinical trial utilizes 3D-printed, bioresorbable splints. What are the advantages of this innovative approach compared to traditional treatments for tracheobronchomalacia?
Dr. Sharma: Traditional treatments for severe TBM were limited and often unsuccessful. This new approach offers several key advantages:
Personalization: These 3D-printed splints are custom-designed to precisely match each infant’s unique airway anatomy. This ensures a perfect fit, maximizing effectiveness and minimizing complications.
Bioresorption: The material is designed to be absorbed by the body over time, eliminating the need for a second surgery to remove the implant. This is particularly crucial for rapidly growing infants.
Minimally Invasive: The implantation procedure is often less invasive than traditional surgeries, potentially reducing surgical risks associated with general anesthesia and large incisions.
Improved Outcomes: The early success in treating infants with these splints suggests improved respiratory function, potentially reducing reliance on ventilators and improving overall quality of life.
Interviewer: The article highlights a collaboration between Michigan Medicine and Materialise. what role does 3D printing technology play in this advancement?
dr. Sharma: 3D printing is absolutely pivotal. It allows for the creation of complex, customized structures that would be impossible to manufacture using conventional methods.the precision of 3D printing enables the creation of splints that perfectly conform to the infant’s airway, improving the chances of successful treatment. Materialise’s expertise in 3D printing biocompatible materials is crucial to this success. Their manufacturing capabilities ensure high quality and consistent production of these life-saving devices. The partnership between the hospital providing clinical expertise and the manufacturer possessing technical expertise is vital.
Interviewer: The clinical trial itself is an essential step. What are the key objectives of this eight-year study, and what kind of impact could successful FDA approval
3D-Printed Hope: Revolutionizing Infant Airway Treatment with Bioresorbable Splints
Is it possible to imagine a future where life-threatening airway conditions in infants are treated with personalized,dissolvable 3D-printed devices? The answer,thanks to groundbreaking research,is a resounding yes.
Interviewer: Dr. Anya Sharma, a leading pediatric pulmonologist, welcome to World Today News. Your expertise in pediatric respiratory diseases is highly respected. Let’s delve into the recent clinical trial focusing on 3D-printed bioresorbable airway splints for infants with tracheobronchomalacia. Can you explain this condition in simple terms for our readers?
Dr.Sharma: Tracheobronchomalacia, or TBM, is a condition where the cartilage supporting the trachea (windpipe) and bronchi (main airways) is weak or underdeveloped. This weakness causes the airways to collapse during breathing,leading to significant breathing difficulties – wheezing,shortness of breath,and even life-threatening respiratory distress in severe cases. In essence,the airway isn’t rigid enough to stay open properly. It is especially challenging in infants as they are entirely reliant on effective airway function. Many infants with severe TBM depend on ventilators for support. Understanding the underlying mechanisms of this condition is critical to developing effective treatments.
Interviewer: The clinical trial utilizes 3D-printed, bioresorbable splints. What are the advantages of this innovative approach compared to traditional treatments for tracheobronchomalacia?
Dr. Sharma: Traditional treatments for severe TBM were limited and often unsuccessful. This new approach offers several key advantages:
Personalization: These 3D-printed splints are custom-designed to precisely match each infant’s unique airway anatomy. This ensures a perfect fit, maximizing effectiveness and minimizing complications. The ability to create a perfectly tailored splint is a major step forward.
Bioresorption: The material is designed to be absorbed by the body over time, eliminating the need for a second surgery to remove the implant. This is particularly crucial for rapidly growing infants. This avoids the risks and challenges associated with a second procedure.
Minimally Invasive: the implantation procedure is frequently enough less invasive than traditional surgeries, potentially reducing surgical risks associated with general anesthesia and large incisions. This means less trauma for the infant.
Improved Outcomes: The early success in treating infants with these splints suggests improved respiratory function, potentially reducing reliance on ventilators and improving overall quality of life. This offers a significant improvement in prognosis for affected children.
Interviewer: The article highlights a collaboration between Michigan Medicine and Materialise. What role does 3D printing technology play in this advancement?
Dr. Sharma: 3D printing is absolutely pivotal.It allows for the creation of complex, customized structures that would be impossible to manufacture using conventional methods. the precision of 3D printing enables the creation of splints that perfectly conform to the infant’s airway,improving the chances of successful treatment. Materialise’s expertise in 3D printing biocompatible materials is crucial to this success. Their manufacturing capabilities ensure high quality and consistent production of these life-saving devices. The partnership between the hospital providing clinical expertise and the manufacturer possessing technical expertise is vital.This collaborative effort is a model for successful medical innovation.
Interviewer: The clinical trial itself is an essential step. What are the key objectives of this long-term study, and what kind of impact could successful FDA approval generate?
Dr. Sharma: The primary objectives of this clinical trial are to rigorously evaluate both the safety and efficacy of these 3D-printed bioresorbable splints in treating infants with tracheobronchomalacia. This involves careful monitoring of respiratory function, growth, and any potential complications. Successful FDA approval would have a transformative impact. It would mean wider access to this life-changing treatment for infants suffering from this serious condition, potentially saving lives and improving the quality of life for many families. It could also inspire further innovation in 3D-printed medical devices for a range of pediatric conditions. This represents a huge step forward in pediatric respiratory care.
Interviewer: What are the potential long-term implications of this research beyond the immediate treatment of tracheobronchomalacia?
Dr. Sharma: The success of this research could serve as a blueprint for the advancement of 3D-printed, bioresorbable devices for other pediatric airway conditions and potentially even other areas of medicine. The ability to personalize treatment at this level holds immense promise for the future of personalized medicine across various specialties. The customization and bioresorbable nature are key features which have broad implications in medical device development.
Concluding Thoughts: This groundbreaking research offers a beacon of hope for infants with severe tracheobronchomalacia and could revolutionize treatment approaches for a variety of pediatric and potentially adult conditions. The success in this clinical trial may significantly change the landscape of pediatric respiratory care, paving the way for other groundbreaking advancements in 3D-printed medical devices. We encourage you to share your thoughts and comments below.