Development of a novel pediatric lvad for home discharge of children awaiting heart transplant

The National Heart, Lung, and Blood Institute awarded Corvion, Inc. $2,999,968 on August 10, 2026, under the Cardiovascular Diseases Research program (CFDA 93.837) to develop a novel pediatric left ventricular assist device (P-LVAD) enabling children with end-stage heart failure to discharge home while awaiting heart transplantation or living long-term with the device. This is a Project Grant (SBIR Phase II).

Corvion will engineer an implantable, ultra-low-power blood pump combining hydrodynamic bearing and magnetic levitation technologies to achieve approximately 1.0 watt power consumption and unprecedented compactness suitable for pediatric implantation, paired with child-sized wearable batteries. The P-LVAD addresses critical limitations of the Berlin Heart Excor—currently the only mechanical circulatory support system available for children in the United States—whose large size and complexity mandate hospitalization with severely restricted patient mobility until transplantation. Corvion's hybrid magnetically levitated pump design contrasts with existing adult-sized high-power LVADs (~8 watts) that are too large and heavy for children.

The award period runs from August 10, 2026, through July 31, 2029. Work is performed in Webster, Texas. The device will substantially improve quality of life for the approximately 35,000 children in the United States living with heart failure by enabling home-based mechanical circulatory support.

Abstract

Our ultimate objective is to develop a pediatric left ventricular assist device (P-LVAD) enabling children with end-stage heart failure to go home while awaiting a heart transplant or live with the device long term. Receiving mechanical circulatory support (MCS) at home while awaiting a heart transplant is critical because IT substantially improves the child's quality of life. P-LVAD's key enabling technology is our implantable, ultra-low-power consumption, and hemcompatible blood pump enabling implantation in children. In the united states, heart failure (HF) affects ~35,000 children and heart transplant is the standard treatment for children with end-stage heart failure. For children, berlin heart excor is the only mechanical circulatory support system available and is used for bridge to transplant. Despite berlin heart's successes, its overall size and complexity require hospitalization until transplantation with very limited patient mobility. Berlin heart's pneumatic blood pump is the key limitation resulting in its large size and high complexity; and therefore, long- term child hospitalization until transplantation. While an LVAD (e.g. an adult-sized heartmate 3) can provide sufficient MCS for children, existing high-power consumption LVAD blood pumps (~8 W) with maglev-based technology are too large for child implantation and require wearable batteries too large and heavy for children. In contrast, P-LVAD uses our hybrid magnetically levitated blood pump combining the best features of hydrodynamic bearing and magnetic levitation creating an unprecedently compact, ultra-low-power (~1.0 W), and hemocompatible blood pump. Therefore, P-LVAD's blood pump can be implanted in children and operate from a child-sized, wearable battery. Ultimately, our blood pump's key innovations will enable unprecedented quality of life for children awaiting a heart transplant and create the opportunity for a destination therapy. P-LVAD feasibility was established by prototyping a clinical-scale, pediatric-sized blood pump and achieving ultra-low- power and hemocompatible blood pump operation on the benchtop and in a 3-day chronic ovine study. This sbir direct to phase II project will create the clinical-scale P-LVAD system and complete pre-clinical testing by developing the driveline connecting the implanted blood pump to the external, wearable controller (AIM1), developing the externally worn controller and battery and the external hand-held patient monitor (aim 2), demonstrating definitive performance and biocompatibility of the clinical-scale P-LVAD in a 30-day sheep study (aim 3), and establishing long-term durability of the clinical-scale P-LVAD in a 6-month benchtop accelerated aging durability study (aim 4). An sbir phase IIB project will complete biocompatibility, sterilization, and packaging testing, and complete an early feasibility study (EFS) first-in-human (FIH) study.