The eHeart™ requires a less invasive implant procedure, and is intended to reduce the surgical risks associated with present day implant procedures that require cardiopulmonary bypass support. In addition, the non-blood contact design will reduce the potential complications associated with present day direct blood contact devices such as bleeding, hemolysis, thrombosis, stroke and mechanical breakdown potentially causing death. eHeart™ is intended to reduce symptoms of heart failure and associated re-hospitalizations, as well as to improve exercise tolerance, with the potential to assist in the reverse remodeling of the heart and recovery to a better quality of life.
The eHeart™ is comprised of NeoCardial’s a proprietary ventricular compression chamber jacket, inflow and out flow fluid line with percutaneous lead line that is connected to a bed side or wearable external controller driver and a light weight rechargeable dual battery-pack system. The eHeart™ ventricular assist chamber jacket has a proprietary compression design that provides adjunct external pressure to enhance the ventricles’ ejection faction (EF percentage of blood volume moved out of the heart per beat of the heart). This attempts to return the EF as close to normal as possible, reducing heart work load and permitting recovery while improving blood flow to vital organs. The eHeart™ supplements the native pumping capacity of the heart, preserves the heart in its native entirety, as well as its own ability to respond to the cardiac demands of the patient.
CHARACTERISTICS OF AN IDEAL TEMPORARY SUPPORT DEVICE*
*From Cardiac Surgery in the Adult (3rd Edition 2003), comparisons related to eHeart
eHeart™ systems, short term, Sm., Med., Lg., long term, custom sized to patients heart
eHeart™ system, paced via ECG or pacemaker, unloads during Systole, using direct compression, improving ejection fraction.
Supports the use of an oxygenator as needed, particularly in the group of patients with acute lung injury
eHeart™ system, adaptable as part of a support system for circulatory assist (ECMO).
eHeart™ system, tissue contact surfaces are biocompatible materials that have been used in implantable devices for decades.
eHeart™ system, long-term ambulatory unit is connected to a wearable, light weight, external controller and battery pack, allowing for near normal activities. By design the eHeart system would allow the patient to disconnect from the controller and battery pack for short periods in that the patient’s heart is still functional, versus existing VADs that render the heart to a bladder state and shutdown for any time would be fatal.
eHeart™ systems, when chest is open (sternotomy), for cardiac repair, simple hand positioning, thoracotomy, for long-term, using chamber insert positioning delivery device.
eHeart™ system, is biventricular, has individual chamber size and pressure control for right and left ventricles.
eHeart™ system, has no blood contact, need for anticoagulation would be minimal, if any.
eHeart™ system, chamber portion has no direct blood contact and creates minimal required pressure imported on tissue surfaces so as not to bruise or damage sub-surface vasculature.
eHeart™ systems are designed for short-term and long-term. The short-term units can be the emergency sm., med., lg. chambers or for diagnosed short-term potential curable disease (Myocarditis) a custom unit could be developed, approximate 72 hour turnaround from diagnoses to implant.