In this project, Cardiac Dynamics will develop the first non-surgical, percutaneous system for attachment to a long-term left ventricular assist device (LVAD) for patients with advanced heart failure. Currently, a majority of the patients who can be considered potential candidates for long-term LVAD implantation do not receive this therapy because of the very high risks associated with the surgery and due to the limited number of tertiary care centers that offer this complex surgery. Providing the same treatment option for these patients, but non-surgically in a catheterization laboratory will increase accessibility to LVAD devices by reducing the procedural risk and increasing the number of available centers. In Phase I of this project, functional prototypes will be designed, fabricated and tested. Phase II will involve finalizing the device design, materials, manufacturing and assembly procedures under a quality system and also performing the bench and animal testing necessary to demonstrate safety and efficacy in support of a regulatory submission. The resulting product will be a much needed non-surgical option for patients with advanced heart failure.
The goal of this project is to develop a catheter-based, non-surgical system for connecting a left ventricular assist device to patient a suffering heart failure. By avoiding open heart surgery, this system will benefit a significant number of patients who need an assist device but are not suitable candidates for surgery.