Cardiovascular devices for congenital heart diseases

Aortic coarctation is a congenital heart disease characterized by the narrowing of the aorta and represents approximately 8% of congenital heart defects. This alteration causes an obstruction of blood flow and a pressure gradient between the proximal and distal territories of the aorta, with significant hemodynamic consequences if not properly treated.

Currently, therapeutic options include open surgery, balloon angioplasty, and metallic stent implantation. Despite the advances achieved these options present specific limitations in the pediatric population. In the case of permanent implants, the vascular growth of the patient requires new dilations or additional procedures over time.

In this context, Dr. Francesc Canalejo Codina’s doctoral research, developed within the Bioengineering program at IQS under the title Design of a pediatric stent to treat aortic coarctation, has been oriented towards the design, manufacturing, and characterization of a new device, conceived to respond to the mechanical and biological requirements typical of patients in the growth phase, with the aim of reducing re-interventions and improving long-term clinical outcomes. The thesis was directed by Dr. Jordi Martorell López from the Vascular Engineering and Applied Biomedicine Group – GEVAB, Dr. Mercedes Balcells Camps from the GEVAB group and the Institute for Medical Engineering and Science of the Massachusetts Institute of Technology – MIT, and Dr. Andrés García Granada from the Industrial Products Engineering Group – GEPI. The research was carried out in collaboration with Dr. Marta Pegueroles from the Biomaterials, Biomechanics and Tissue Engineering Research Group – BBT at UPC and Dr. Elazer R. Edelman from the Edelman Lab – MIT.

The project began with the definition of the clinical and technical requirements of the device, through anatomical analysis, tissue study, and interaction with healthcare professionals. Subsequently, computational models were developed for prototypes manufactured with polycaprolactone, a bioresorbable biomaterial, incorporating an auxetic geometry capable of offering an adaptive mechanical response.

In a second phase, in vitro studies were conducted to analyse the relationship between manufacturing processes, implantation, and biological response. This work allowed for the establishment of design criteria aimed at improving the functional behavior and safety of the device.

Finally, preclinical validation was carried out using an animal model with femoral catheterization in New Zealand white rabbits, serving as a minimally invasive platform to evaluate pediatric cardiovascular devices. The results showed excellent biocompatibility characterized by rapid tissue integration into the aorta after one month of implantation.

In his research, Dr. Canalejo has achieved a structure adapted to the pediatric aorta, which aims to go beyond localized mechanical support, promoting arterial remodeling and accommodating somatic growth. In this way, he has achieved the goal of reducing new interventions and promoting integral vascular health in children with aortic coarctation

Related Publications

Francesc Canalejo et al., 3D printed polymeric stent design : Mechanical testing and computational modelling, Materials & Design, Vol. 247, 2024, 113395

Francesc Canalejo et al, Integrating stent design and microstructural characterization to improve clinical outcomes of bioreabsorbable stents, Materials & Design, Volume 260, 2025, 115013  

Patent

The developed technology has been the subject of a patent: Canalejo F., Martorell J., Balcells M., Garcia A., Edelman, E.R., Systems and methods for Use and Manufacturing of an Adaptably Dynamic Stent, Provisional Patent application, US-PTO – 63/864,568

The research for this thesis was also carried out with the collaboration of Boston Children’s Hospital and Hospital Sant Joan de Déu.

The device developed within the framework of this thesis has obtained prominent international recognition in the field of pediatric medical innovation. In 2024, the technology was recognized among the six most relevant projects worldwide in pediatric medical device innovation by the Alliance for Pediatric Device Innovation, and subsequently ranked among the top three projects in Europe within the Impact4Kids acceleration program, promoted by Stanford Biodesign and i4Kids Europe.

The research linked to Dr. Canalejo Codina’s thesis has received various competitive grants and academic distinctions. These include a PhD fellowship funded by the Ministerio de Ciencia e Innovación – Agencia Estatal de Investigación, within the framework of the PolyCoarct project; the grant from the Private Foundation Daniel Bravo Andreu for biomedical research in prestigious international centers; the Scholarship for the best doctoral thesis project awarded by the College of Industrial Engineers of Catalonia; the Banco Santander award for predoctoral researchers; as well as other recognitions for academic and scientific excellence.

Additionally, the framework of this research has received grants from AGAUR – Generalitat of Catalonia, Alliance for Pediatric Device Innovation, Impact4Kids, “la Caixa” Foundation, MIT-Spain, MIT Deshpande Center for Technological Innovation, MIT Mechanical Engineering, and the National Science Foundation. As a result, the PolyCoarct project has participated in leading international forums, with presentations at SITE, MIT, Harvard, MedTech Conference, Barcelona Deep Tech Summit, Pediatric Investment Forum, Midwest Pediatric Device Consortia, Impact LaunchPad, and other specialized forums in technological transfer, biomedical innovation, and pediatric medical devices.