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SynCardia Systems, Inc.

Hospital Certification Overview

The SynCardia temporary Total Artificial Heart is instantly available off the hospital shelf at more than 100 SynCardia Certified Centers. To become a Certified Center, hospitals must apply for and complete a rigorous, four-phase certification program, including the first proctored implant by an experienced Total Artificial Heart surgeon.

Phase III certification is the first implant proctored by an experienced Total Artificial Heart surgeon.
Phase III certification is the first implant proctored by an experienced Total Artificial Heart surgeon.

Phase I – Introduction to the Total Artificial Heart

Location: SynCardia regional certification center

  • Lectures
  • Hands-on instruction with the SynCardia temporary Total Artificial Heart and drivers
  • Patient simulator
  • Animal implant surgery

Phase II – Implant-Ready

Location: Trainee hospital

Prepares the surgical team for the first on-site Total Artificial Heart implant and certifies the center as implant-ready. Hospital drivers and the patient simulator are shipped so the implant team can practice and train other team members.

Phase III – Proctored First Implant

Location: Trainee hospital

  • Selection of an appropriate patient
  • First implant, proctored by an experienced Total Artificial Heart surgeon

Phase IV – Patient Discharge

Location: Trainee hospital
Includes training hospital staff, patients and caregivers on discharge procedures with the driver, including:

  • Driver operation
  • Driveline dressing care
  • Managing daily activities
  • Physical therapy guidelines
  • Daily monitoring of driver parameters and vital signs

Multi-Disciplinary Approach

The members of the implant team will be responsible for one or more of the following key areas:

  • Implant surgery (surgeons)
  • Surgery support (scrub nurse or physician’s assistant, perfusionist or anesthesiologist)
  • Anticoagulation (hematologist, pharmacist or anesthesiologist)
  • Driver support (biomedical engineer, device coordinator or perfusionist)
  • Post-operative patient management (ICU nurse, nurse trainer or device coordinator)
  • Heart failure cardiology (cardiologist or intensivist)
  • Study coordinator (if participating in a clinical study)
  • Discharge coordinator (device coordinator, transplant coordinator)

To get certification materials, send an email to SynCardia.

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