Cardiac Dynamics LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Project Summary In this projectCardiac Dynamics will develop the first non surgicalpercutaneous system for attachment to a long term left ventricular assist deviceLVADfor patients with advanced heart failureCurrentlya 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 surgeryProviding the same treatment option for these patientsbut non surgically in a catheterization laboratory will increase accessibility to LVAD devices by reducing the procedural risk and increasing the number of available centersIn Phase I of this projectfunctional prototypes will be designedfabricated and testedPhase II will involve finalizing the device designmaterialsmanufacturing 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 submissionThe resulting product will be a much needed non surgical option for patients with advanced heart failure NARRATIVE The goal of this project is to develop a catheter basednon surgical system for connecting a left ventricular assist device to patient a suffering heart failureBy avoiding open heart surgerythis system will benefit a significant number of patients who need an assist device but are not suitable candidates for surgery