Advancing Transcatheter Solutions for Unmet Cardiovascular Needs

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.

Explore IntelliStent®

Scientific Rationale

Investigational Device Notice: 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.

The Clinical Challenge

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.

Surgical Pulmonary Artery Banding

Open surgical procedure requiring thoracotomy or sternotomy.

Limited
Alternatives

No purpose-built transcatheter solutions currently exist for controlled pulmonary flow restriction.

Need for
Adjustable Therapy

Clinical management often requires individualized modulation as patient physiology changes over time.

Scientific Foundation

Pulmonary Flow Modulation as a Therapeutic Strategy

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.

Schranz et al. Circulation 2018
Schranz et al. Translational Pediatrics 2019
Schranz et al. EHJ Case Reports 2023

IntelliStent^Ⓡ

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.

Investigational Device Notice: 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.

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

A Structured Regulatory Pathway

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.