HeartPoint Global is developing investigational catheter-based technologies designed to provide minimally invasive alternatives for patients with limited therapeutic options in heart failure and congenital cardiovascular disease.
Despite advances in cardiovascular medicine, significant unmet needs remain for patients requiring pulmonary blood flow modulation. Existing treatment strategies, including surgical pulmonary artery banding, are associated with procedural complexity, prolonged recovery, and significant morbidity, particularly in pediatric populations.
Open surgical procedure requiring thoracotomy or sternotomy.
No purpose-built transcatheter solutions currently exist for controlled pulmonary flow restriction.
Clinical management often requires individualized modulation as patient physiology changes over time.
Pulmonary artery flow restriction has demonstrated the potential to improve ventricular mechanics through controlled hemodynamic modulation.
By increasing right ventricular pressure, septal geometry may be altered to support left ventricular function and promote ventricular remodeling in selected patient populations.
A patented multi-lumen transcatheter system designed to enable controlled, adjustable, and potentially reversible pulmonary blood flow restriction.
IntelliStent has been designed to support controlled, adjustable and potentially reversible pulmonary blood flow modulation through familiar interventional techniques.
| Design Feature | Design Intent |
|---|---|
| Self-expanding nitinol frame | Designed for stable deployment and vessel apposition |
| Multi-lumen architecture | Intended to enable controlled pulmonary flow restriction |
| Nested configuration | Incremental flow modulation |
| Balloon-expandable adjustment | Designed to allow flow-restriction adjustment |
| Transcatheter delivery | Minimally invasive implantation |
HeartPoint Global is advancing IntelliStent through a staged clinical development strategy informed by early regulatory engagement, preclinical evidence, and defined investigational objectives. The current development program focuses on evaluating IntelliStent in carefully selected patient populations where controlled pulmonary blood flow modulation may provide meaningful clinical benefit.
IntelliStent® is an investigational medical device and has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The device is currently under development and is not available for commercial sale. Any information presented is intended solely for educational and informational purposes and should not be interpreted as promoting the safety or effectiveness of the device.
This project is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award No. R44HL182590. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.