[Capstone Project Spotlight] IntelliStent®: A Non Surgical Endovascular Treatment for Congenital Heart Disease and Cardiomyopathy

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 Master of Translational Medicine Program at UC Berkeley and UCSF partnered with HeartPoint Global for this year’s Capstone project. This month, we sat down with Seth Bogner and Anthony Medigo from HeartPoint Global to learn more about their inspiring work in the field.

The Core Issue: A Global Cardiovascular Health Crisis

Congenital heart disease (CHD) is the most common type of birth defect, affecting 2.4 million infants annually worldwide, along with millions of untreated pediatric and adult patients. Current treatments, like pulmonary artery banding (PAB), are highly invasive, carry significant surgical risks (20% mortality rate), and involve long recovery periods. Moreover, access to these treatments is severely limited in low- and middle-income countries, exacerbating global health disparities and leaving many children without viable options.

The IntelliStent® addresses this unmet need by offering a minimally invasive, adjustable, and reversible stent system. It enables precise blood flow regulation post-implantation without requiring additional surgeries. This innovative approach applies not only to CHD but also to conditions like dilated cardiomyopathy and single ventricle disease. Preclinical testing in animal models has demonstrated the device’s safety and efficacy. IntelliStent® is adjustable and can be adapted to patient growth or other changes in the patient’s condition, making it a long-term solution for pediatric patients. By minimizing invasiveness and enhancing adjustability, IntelliStent® has the potential to transform CHD treatment, improving outcomes and accessibility for patients globally.

IntelliStent® is a Game-Changer

The IntelliStent® system, developed by HeartPoint Global, provides a groundbreaking solution for CHD. This minimally invasive device regulates pulmonary artery blood flow while reducing surgical risks and recovery times. Its adjustability allows physicians to optimize blood flow post-implantation, accommodating patients’ changing needs over time without additional surgeries.

By improving safety, outcomes, and affordability, IntelliStent® expands access to treatment for underserved populations, particularly in low- and middle-income countries. Its globally patented design leverages familiar stent technologies, ensuring physician acceptance and ease of integration into existing medical practices. IntelliStent® is a game-changer in the fight against CHD.

Why Their Solution is a One-of-a-kind

• Less Invasive: Unlike traditional PAB surgery, which requires open-chest procedures, IntelliStent® is minimally invasive, significantly reducing surgical trauma and associated risks.
• Cost-Effective: The device is more affordable than PAB surgery and long-term drug therapies, making it a viable solution for healthcare systems with limited resources.
• Adjustable: IntelliStent®’s unique adjustability eliminates the need for repeat surgeries, reducing long-term healthcare costs and enhancing patient safety.
• Versatile: Made from nitinol, the device is adaptable and adjustable for patient growth, making it particularly suitable for pediatric patients.

Working with MTM Students

Master of Translational Medicine (MTM) students are instrumental in advancing IntelliStent®. Their contributions include:

• Enhancing prototype designs to optimize functionality.
• Conducting regulatory gap analyses to streamline approval processes.
• Analyzing market dynamics and engineering usability for diverse healthcare settings.
• Supporting NIH grant development and preparing clinical trial protocols.
• Analyzing preclinical data to validate safety and efficacy.

Their multidisciplinary approach accelerates IntelliStent® ‘s readiness for first-in-human clinical trials and eventual market entry.

The People Behind This Innovative Solution

HeartPoint Global’s leadership team combines decades of expertise in cardiovascular medical device development, clinical research, and business strategy. Their passion for IntelliStent® stems from a commitment to addressing health disparities in pediatric cardiovascular care. With firsthand knowledge of the limitations of current treatments, they are dedicated to creating safer, more effective, and accessible solutions that improve quality of life and survival rates for millions of children and adult patients worldwide.

HeartPoint Global is headquartered in New York City, with offices and collaborations in the U.S., Ireland, Italy, and Israel. For more information, please visit their website at www.heartpointglobal.com or reach out to their CEO, Seth Bogner, at sb@heartpointglobal.com.

The IntelliStent® has the potential to make a profound impact on global healthcare. By addressing the unmet needs of children and adults in underserved regions, it contributes to advancing health equity worldwide.

They have built partnerships with leading medical institutions and organizations such as the Cardiovascular Research Foundation, PICS Society, and UC Berkeley X UCSF MTM Program. These collaborations are pivotal in fostering innovation and advancing the device toward clinical trials and commercialization.

IntelliStent®’s patents extend to all blood-carrying vessels, allowing for future applications in other indications across cardiology and beyond. This broad applicability underscores IntelliStent®’s potential to revolutionize not only CHD treatment but also other medical fields, paving the way for transformative healthcare solutions.

HeartPoint Global’s commitment to improving access to cardiovascular treatment reflects the power of innovative medical technology, creating a healthier, more equitable world.