Intellistent
Overview
HeartPoint Global, a pioneer in the field of innovative cardiovascular treatments, is using their patented minimally invasive intervention Intellistent® to revolutionize pediatric and adult cardiovascular healthcare. Their safer and more affordable solution to congenital heart disease and cardiomyopathy is a part of their mission to “use technology to reduce inequality in healthcare”.
The Issue
Congenital heart disease (CHD) affects approximately 1% of newborns, which means that around 40,000 births per year in the United States are affected by the condition. Malformation in the cardiology system results in PAH and LV-DCM, leading to the need for transplantation. Currently, there are no non-invasive solutions for PAH and LV-DCM caused by CHD in infant populations.
Approach
To address this challenge, we will help adapt HeartPoint Global’s existing stent and delivery system (designed for those 5 years and older) for individuals under the age of 5. This will allow these children to receive a minimally invasive, on-label treatment for their conditions.
MTM Student Engagement
MTM students are working with HeartPoint Global to develop the infant stent prototype, assist with the FDA IDE submission for the adolescent stent, prepare NIH grant submissions, and improve the Quality Management System (QMS).
Project Brief
