Addressing high blood pressure in the pulmonary artery, often stemming from heart defects, can be financially burdensome, with artificial hearts costing upwards of $190,000.
Heart disease accounted for approximately one in five deaths in the United States in 2020. Even minimally invasive procedures like pulmonary artery banding, dating back to the era of President Harry Truman, require access to the chest cavity.
HeartPoint Global, a Florida-based company, is pioneering a new treatment called Intellistent, aiming to provide a minimally invasive alternative for pulmonary arterial hypertension associated with Congenital Heart Disease. Unlike traditional methods, Intellistent, expected to cost around $4,000, is delivered through the leg, offering a more accessible option.
Human trials for Intellistent are set to begin this year. CEO Seth Bogner believes that Intellistent could offer a more affordable and practical solution compared to existing options like artificial hearts or pulmonary artery banding. The device gradually reduces flow and pressure in the pulmonary artery, allowing for gradual adjustments without sudden drastic reductions, achieved through nested stents guided by an algorithm.
While pulmonary artery banding has been standard practice since 1951, HeartPoint Global's innovative approach aims to eliminate the need for invasive chest cavity access. By delivering the device through the leg, the company aims to revolutionize treatment for pulmonary arterial hypertension.
Intellistent's ability to provide gradual adjustments through nested stents reduces the need for multiple invasive surgeries often required with traditional methods. Unlike palliative treatments, Intellistent has the potential to be curative by addressing underlying heart disease, as noted by former University Hospital Zurich Cardiac Surgery Department director Paul Vogt.
HeartPoint Global faces challenges in its development journey, including conducting human trials and navigating supply chain hurdles. The company aims to commence human studies by year-end and hopes to secure FDA breakthrough device designation in the future.
As HeartPoint Global advances, its mission is to offer a groundbreaking solution for pulmonary arterial hypertension associated with Congenital Heart Disease, providing patients with a more accessible and effective treatment option.