The eHeart™ is a thoracotomy-implanted device that will consist of several key components:
- Implanted around the outside of the ventricles of the heart is the dual chambered (right and left ventricle) expandable compression jacket. Once expanded, it can become a totally implantable passive constraint device to assist in the maintenance of the outer wall parameters of the ventricles. When connected to the Controller/Driver, it will assist the heart during systole as either a left ventricular assist, right ventricular assist or a bi-ventricular assist device. The ventricular chamber jacket and drive line are made of proven biocompatible implant materials.
- The Controller/Driver systems will be constructed primarily from components presently used in pulsation or counter pulsation devices. It will consist of a bedside console and a battery operated wearable ambulatory unit.
- The controller/driver units will auto adjust to patient cardiac demand via ECG. The unit will include adjustable controls for passive constraint pressure and compression assisted pulsation rates. The company believes that the eHeart™ will dramatically improve the adoption of non-blood contact bi-ventricular circulatory support for the underserved patient populations, respectively falling into the Class 3B ambulatory, and Class 4 categories of congestive heart failure. This is due to the potential of eHeart™ to mitigate complication concerns related to current VAD products on the market.
Circulatory support design attributes unique to eHeart™:
- Designed for use with drug therapy for the reversal of heart failure, a bridge to recovery
- Engineered to be in-line with the cost saving and outcome-improving goals of the modern U.S. healthcare system
- Engineered to be a dominant, cost effective technology for a large, challenging and underserved patient population
- Designed to supplement native cardiac output without surgical intervention into the heart or aorta
- Elimination of direct blood contact complications
- Designed for implant without the need of cardiopulmonary bypass
- Customized wrap for each patient using 3-D printing