Approximately 40,000 children are born with congenital heart disease each year in the US alone.
A desperately high number which currently requires invasive and uncomfortable medical care throughout the children's lives as they grow.
Sophie-Charlotte Hofferberth, CEO & Co-Founder of Autus Valve Technologies and her pioneering work in Medical Device innovation creating the Autus Valve, may just be the lifesaving solution those in need have been waiting for.
Clinical trials have now begun at Boston Children's Hospital for the Autus Valve, the first prosthetic pulmonary valve replacement designed exclusively for pediatric patients that can expand within a child's anatomy over time.
Rather than undergoing risky and potentially life threatening replacement surgeries every few years, as is current practice, a child will be able to receive a valve customised to their individual body size and, if necessary, adjusted through a minimally-invasive transcatheter balloon dilation procedure to help maintain blood flow.
The child may not require another replacement procedure until reaching adulthood.
The valve which was first implanted in a young patient at Nationwide Children's Hospital in late 2021 as part of a collaborative clinical study involving Boston Children's Hospital, NewYork-Presbyterian Hospital & Columbia University Irving Medical Center.
Hofferbeth commented 'it's thrilling and incredibly inspiring that we've reached the stage where we can witness the device's impact on patients,"
Christopher Baird, MD, Director of the hospital's Congenital Heart Valve Program stated that 'the Autus Valve continues the hospital's pace of innovation in transcatheter valve replacement technology, following other notable breakthroughs made by the Boston Children's cardiac catheterisation team.'
This marks a massive step in the right direction for improving medical treatment for children suffering from heart disease.
So... how was it developed?
Hofferberth and her team worked with Elazer Edelman, MD, Ph.D., of the Massachusetts Institute of Technology to combat the current medical issues and develop a size-adjustable valve with a long lifespan.
They conducted studies on growing lambs and discovered that the prototypes of the replacement pulmonary valve could be fitted and expanded in sync with the growth of heart anatomy without compromising the valve's frame or material.
The device's leaflets were then made of a polymer that had a proven track record of use in pediatric pulmonary valves, instilling confidence in the team.
After remarkable success the team was ready to bring it to clinical patient trials.
The procedure:
Before implantation, doctors can adjust the valve diameter to match a patient's heart anatomy.
Following implantation, catheter balloon dilation can be used by cardiac catheterisation specialists to expand the valve if it becomes too small due to a child's growth spurt.
An echocardiogram is used to evaluate the valve's performance and integrity in controlling blood flow.
Hofferberth states that if a valve expansion is necessary after implantation, the child can expect to recover within just a few hours.
Click the video below to understand how it works:
Sources:
https://medicalxpress.com/news...
https://www.childrenshospital....