Clinical Confidence for Advanced Biventricular Heart Failure
SynCardia partners with transplant centers, surgeons, heart failure programs, perfusion teams, and hospital leadership to support the use of the SynCardia Total Artificial Heart (STAH) in appropriate patients.
The STAH is FDA-approved in the United States as a bridge to transplantation for cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. This page provides clinical resources related to patient selection, implantation, program readiness, education, and support.
Why Physicians Choose SynCardia
Programs Managing Severe Biventricular Failure Require More Than a Device
SynCardia supports clinicians with:
- Established bridge-to-transplant therapy
- Dual-size platform (70cc and 50cc)
- In-hospital and portable driver systems
- Education and case-based learning resources
- Program implementation support
- Ongoing customer service and technical assistance
Frequently Asked Questions
Clinical Data
Therapy Designed for Patients with Few Remaining Options
The SynCardia Total Artificial Heart is intended for carefully selected transplant-eligible patients with severe biventricular failure who may not be adequately served by isolated ventricular support strategies.
Two available sizes support broader anatomical fit considerations:
70cc STAH
- Maximum stroke volume: 70 mL
- Cardiac output: up to 9.5 L/min
50cc STAH
- Maximum stroke volume: 50 mL
- Cardiac output: up to 7.5 L/min
- FDA Summary of Safety and Effectiveness
- Feldman D, Pamboukian SV, Teuteberg JJ, et al. The 2013 International Society for Heart and Lung Transplantation Guidelines for mechanical circulatory support: executive summary. J Heart Lung Transplant. 2013;32:157-87.
- Shah KB, Thanavaro KL, Tang DG, et al. Impact of INTERMACS profile on clinical outcomes for patients supported with the total artificial heart. J Card Fail 2016;22(11):913-919.
- Cook JA, Shah KB, Quader MA, et al. The total artificial heart. J Thorac Dis. 2015;7(12):2172–80.
Patient Selection
Selecting the Right Patient at the Right Time
Successful outcomes begin with appropriate patient selection and timely referral. Patients who may be considered—consistent with approved labeling and clinical judgment—can include those experiencing:
- Irreversible biventricular failure
- Decompensated right heart failure on LVAD support
- Failure to wean from ECMO
- Allograft failure or rejection
- Recurrent ventricular tachycardia/fibrillation
- Restrictive or infiltrative cardiomyopathy
- Congenital heart disease in select cases
- Structural pathology limiting VAD options
Sizing Considerations
Chest fit assessment, including T10 measurement and imaging review, may assist in determining appropriate device size selection.
Surgical Technique
Implantation with Familiar Principles, Specialized Expertise
Similar to heart transplantation, implantation of the SynCardia Total Artificial Heart replaces both ventricles and all four native heart valves while preserving the atria and roots of the great vessels. The procedure requires multidisciplinary planning and institutional readiness.
Resources Include:
- Surgical workflow overview
- OR readiness guidance
- Case-based learning
- Implant best practices
- Post-op transition planning
A physician-focused video reviewing implantation principles, operative considerations, and post-operative support transitions.
Instructions for Use
Important Safety Information
Please review complete Instructions for Use for full indications, contraindications, warnings, and precautions. These materials are intended for use by qualified healthcare professionals only. Proper training is required prior to use of SynCardia systems. Refer to institutional protocols and approved training programs before clinical use.
Regulatory Labeling
70cc SynCardia Total Artificial Heart
● U.S. FDA: 2004
● Health Canada: 2005
50cc SynCardia Total Artificial Heart
● U.S. FDA: 2020
● Health Canada: 2016
Companion 2 Driver
● U.S. FDA: 2012
● Health Canada: 2013
Freedom® Driver
● U.S. FDA: 2014
● Health Canada: 2011
Training & Education
Ongoing Learning for Advanced Heart Failure Teams
SynCardia provides education resources to help physicians and care teams build confidence in patient selection, implantation workflows, and program growth. Access live events, on-demand webinars, and practical training designed for centers at every stage of experience.
Program Implementation
Ongoing Learning for Advanced Heart Failure Teams
- Administrative readiness
- Clinical champion alignment
- ICU / OR workflows
- Staff education pathways
- Inventory / equipment planning
- Referral strategy development
Whether launching a new program or strengthening an existing one, SynCardia works collaboratively with hospital stakeholders.
Establishing a STAH Program at Your Hospital
Establishing a STAH program
Reimbursement Resources
Navigating Access Pathways
Peer-Reviewed Publications
Published Clinical Experience
Examples include:
- The Total Artificial Heart
- Implantation technique reviews
- INTERMACS profile analyses
- Challenging anatomy case reports
