Each year, over 5 million people in the U.S. are diagnosed with heart valve disease, a condition that lacks long-term treatment options. When a heart valve is damaged due to a congenital defect, lifestyle choices, or aging, blood flow can become disrupted, potentially leading to life-threatening complications. Valve replacement and repair are the only treatments for severe cases, often requiring multiple surgeries. Most replacement valves are made from animal tissue and typically last 10 to 15 years. Pediatric patients face additional challenges as their growing hearts need several reinterventions.
Credit:Catherine Barzler, Georgia Institute of Technology
The bioresorbable heart valve (yellow) promotes tissue regeneration and a 3D-printed heart model.
Researchers at Georgia Tech have developed a 3D-printed bioresorbable heart valve designed to fit each patient’s anatomy. Once implanted, the body absorbs the valve and replaces it with new tissue that takes over its function. The project originated in the labs of Lakshmi Prasad Dasi and Scott Hollister in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University.
“This technology is very different from most existing heart valves, and we believe it represents a paradigm shift,” said Dasi, the Rozelle Vanda Wesley Professor in Biomedical Engineering on Georgia Tech’s website. “We are moving away from using animal tissue devices that don’t last and aren’t sustainable and into a new era where a heart valve can regenerate inside the patient.”
Hollister, a professor and Patsy and Alan Dorris Chair in Pediatric Technology, emphasized the importance of this approach for children. “In pediatrics, one of the biggest challenges is that kids grow, and their heart valves change size over time,” he said. “Because of this, children must undergo multiple surgeries to repair their valves as they grow. With this new technology, the patient can potentially grow new valve tissue and not have to worry about multiple valve replacements in the future.”
Development and functionality
The heart valve uses poly(glycerol dodecanedioate), a biocompatible, resorbable material with shape memory properties. It can be folded and delivered through a catheter rather than requiring open-heart surgery. Once implanted, the valve returns to its original shape at body temperature and signals the body to generate new tissue. The device is fully absorbed within months.
“From the start, the vision for the project was to move away from the one-size-fits-most approach that has been the status quo for heart valve design and manufacturing and toward a patient-specific implant that can outlast current devices,” said Sanchita Bhat, a research scientist in Dasi’s lab who first became involved in the project as a Ph.D. student.
“Once you have an idea for an implant, it takes a lot of fine-tuning and optimization to arrive at the right design, material, and manufacturing parameters that work. It is an iterative process, and we’ve been testing these aspects in our systems to make sure the valves are doing what they’re supposed to do.”
The valve’s durability is being evaluated using computational models and benchtop studies. Dasi’s lab has a heart simulation system that mimics real heart physiology, testing the valve under patient-specific pressure and flow conditions. A separate machine assesses mechanical durability by simulating millions of heart cycles.
While Georgia Tech’s bioresorbable heart valve is unique in combining 3D printing, bioresorbable polymers, and patient-specific design, it shares principles with other tissue-engineering and regenerative technologies aimed at reducing repeat surgeries and promoting natural healing.
Xeltis has developed bioresorbable heart valves that use the body’s natural healing process to regenerate heart valve tissue. These implants serve as a scaffold, gradually being absorbed as new tissue forms.
Future applications
Developing a material that performs a heart valve function while promoting tissue regeneration presents significant challenges. Medical devices must also undergo extensive testing before being approved for clinical use. The researchers aim to make the technology available first for pediatric patients, as they have fewer treatment options.
“The hope is that we will start with the pediatric patients who can benefit from this technology when there is no other treatment available to them,” Dasi said. “Then we hope to show, over time, that there’s no reason why all valves shouldn’t be made this way.”
Contributors and Funding
Several researchers contributed to the project, including Harsha Ramaraju, Ryan Akman, Adam Verga, David Rozen, Satheesh Kumar Harikrishnan, and Hieu Bui. The development of the bioresorbable material was supported by the National Institutes of Health (NIH/NHLBI R21-126004).
