An illustration of Heartpoint's IntelliStent system, which is designed to use minimally invasive catheter delivery to place adjustable stents to adjust blood flow in the pulmonary arteries.

Heartpoint’s IntelliStent system is designed to use minimally invasive catheter delivery to place adjustable stents that adjust blood flow in the pulmonary arteries. [Illustration courtesy of Heartpoint]

By Seth Bogner, HeartPoint Global

In pediatric cardiology, a persistent challenge revolves around ensuring accessible and effective care for children grappling with congenital heart disease (CHD). CHD affects approximately 1.7% of newborns globally, or 2.4 million, of which 90% have the urgent need for affordable and specialized treatments that call for innovative solutions.

According to a recent article in The Journal of the American College of Cardiology (JACC), economic constraints in many developing nations contribute to delayed diagnosis and treatment for up to 90% of children with CHD, leading to severe consequences such as organ dysfunction and complications like profound cyanosis and polycythemia.

A few years ago, I met with an interventional cardiologist in his office. I couldn’t help but notice a cardiac guidewire displayed on the wall behind his desk. When I asked about it, he shared an astonishing fact — it had been used in surgeries over 200 times in Myanmar. This highlighted the severe shortage of medical supplies and expertise in many developing nations. Typically, a guidewire is a single-use item meant to be discarded after one use. The cardiologist, amazed by the guidewire’s extensive use, felt the need to commemorate this as a testament to the challenges faced in those regions. This encounter sparked my inspiration and determination to bring easily accessible technology to the developing world, especially for individuals who often lack the means or access to surgeries that we take for granted in Western countries.

Developing IntelliStent

An image showing the Heartpoint IntelliStent device and catheter delivery system.

Heartpoint plans to submit its IntelliStent system for regulatory approval in 2025. [Image courtesy of Heartpoint]

The journey with my team began in the lab, focusing on innovation around a transcatheter pulmonary artery band, an intervention that can be placed and adjusted without the risks associated with surgery. A transformation in pediatric cardiac care emerged with IntelliStent — a transcatheter device designed to regulate blood flow within the intravascular space, addressing the urgent need for affordable and specialized care.

With traditional therapeutic strategies, the emphasis is on symptom improvement, leaving a significant unmet clinical need, especially in the pediatric population, where heart transplantation is the only life-saving option for end-stage dilated cardiomyopathy (DCM).

IntelliStent introduces a paradigm shift, especially concerning existing therapies for pediatric dilated cardiomyopathy. Current treatments often fall short, leading to considerations of left ventricular assist devices (LVAD) and transplantation which is not available for patients that don’t live in a country with a well-developed and funded healthcare system This presents significant challenges, especially in the pediatric age range. IntelliStent emerges as a viable and cost-effective alternative, providing a temporary bridge to improve left ventricle function.

When pharmaceutical interventions fall short; the next step may be the use of a LVAD and transplantation, but these options are not widely available, creating challenges even in the U.S. due to the scarcity of organ transplants in the pediatric age group. Consequently, the rationale behind placing a band into the pulmonary arteries becomes evident — a strategy to elevate the pressure in the right ventricle and reshape the interventricular septum’s morphology. This approach proves beneficial for infants, either leading to improvement with the band alone or serving as a bridge to transplant.

An illustration showing Heartpoint Global's IntelliStent catheter delivery system, nitinol reduction stents and balloon expandable stent.

Heartpoint Global’s IntelliStent system includes a catheter delivery system, nitinol reduction stents and a balloon expandable stent. [Image courtesy of Heartpoint]

The placement procedure is straightforward and has minimal risk compared to installing an artificial heart. IntelliStent, a specific arrangement of stents applicable throughout the vascular system, holds the potential for various scenarios requiring pressure or flow reduction in vessels. Looking ahead, there is a growing interest in exploring the translation of this experience for adults. Notably, the cost comparison is striking. While an LVAD in the U.S. incurs a million-dollar annual expense per patient, IntelliStent, by an order of magnitude, is significantly more cost-effective, with costs centered around the intervention rather than an annual basis.

The ability to place and adjust this band without resorting to surgical procedures is a highly sought-after advancement. While pulmonary artery band surgery is an option for specific cases, the global limitations in congenital cardiac surgery often mean that complete repair or pulmonary artery band placement is not readily available, especially for left-to-right shunts resulting from common congenital defects. The introduction of a transcatheter pulmonary artery band becomes crucial in regions where access to congenital cardiac surgery is restricted, offering a potential lifeline for children at risk of developing Eisenmenger syndrome. This approach serves as a means of safeguarding the lungs from excess flow and pressure in the presence of unrepaired congenital cardiac defects, providing a life-saving option for both children and adults with congenital heart malformations. The timing of pulmonary artery band placement hinges on preventing progression to the irreversible stage of shunting, offering flexibility for intervention at any age for those at risk of Eisenmenger syndrome.

IntelliStent’s global impact

Once granted public approval, this groundbreaking device will be disseminated globally, catering to both the developing and developed worlds. The immediate focus lies on meeting the unmet needs, providing access to cardiac care for pediatric patients currently devoid of such resources in the U.S., marking a pivotal step in extending life-saving interventions to those in need.

In developing nations, left ventricular dilated cardiomyopathy is left untreated. Collaborations with organizations like the Eurasia Heart Foundation aim to make a significant impact globally, focusing on working closely with the FDA to bring affordable and specialized care to those in need.

The significance of transcatheter procedures becomes clear when considering the risks associated with general anesthesia during surgery. IntelliStent offers a safer alternative with the ability to conduct transcatheter procedures under moderate sedation. The flexibility to adjust flow and pressure over time, its lower cost, and reduced risk of complications position IntelliStent as a groundbreaking solution.

The unique adaptability of IntelliStent is highlighted by its adjustability, allowing modifications that are not only available during the initial intervention but also at later stages as patient conditions evolve. The importance of accurate restriction of flow is paramount, with the capability to adjust allowing it to be a patient-centric approach with minimal risks.

Imaging studies can be conducted while the patient is awake and follow-ups are less frequent, reducing the burden on both patients and healthcare resources.

Four successful rounds of preclinical studies have laid the foundation for IntelliStent’s safety and efficacy. The system’s ability to achieve the desired effect at a lower rate of pressure reduction enhances patient safety. In-human clinical trials are imminent, focusing on evaluating safety before exploring applications in small children.

The future looks bright, with cardiovascular medtech innovation as a beacon of hope for improved and affordable pediatric cardiac care globally.

A portrait of Heartpoint Global CEO and Chair Seth Bogner.

Heartpoint Global CEO and Chair Seth Bogner [Photo courtesy of Heartpoint]

Seth Bogner is chair and CEO of HeartPoint Global Inc., which provides global, breakthrough medical solutions for cutting-edge cardiac care that are affordable, safe, and minimally invasive. Heartpoint Global is the Cardiovascular Research Foundation (CRF) TCT 2023 Shark Tank (Innovation) Competition winner.

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The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.