EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

Exclusion Criteria

• •Patient has any contraindication as specified in the current version of the IFU of the EXCOR® Pediatric VAD system as shown below:
• •"Patients unable to tolerate systemic anticoagulation therapy should not be implanted with EXCOR components.
• •Magnetic Resonance Imaging (MRI) is contraindicated in patients after being implanted with EXCOR.
• •Patients with aortic valve regurgitation that is more than moderate that cannot be re- paired at the time of implantation should not be implanted with EXCOR. If repair of the aortic valve regurgitation requires surgical closure of the aortic valve, EXCOR should not be implanted. EXCOR is not intended to be used as a total artificial heart and should not be used in this configuration."
• •Patient and/or legal representative has not given written consent to participate in the study (non-consent).
• •Females of childbearing age who are not on contraceptives or surgically sterile or pregnant.