Total Artificial Heart Timeline
Research Begins
Dr. Willem Johan Kolff begins research to develop a heart-lung machine and an artificial heart.
Research Continues
Dr. Kolff emigrates from the Netherlands with his wife and their five children to begin work at Cleveland Clinic as a research assistant.
Finished Development
Dr. Kolff finishes development of one of the first heart-lung machines.
Implants
At the Cleveland Clinic, Dr. Kolff and Dr. Tetsuzo Akutsu conduct a series of animal implants with the artificial heart; a dog survives for approximately 90 minutes.
First Patent
Ventriloquist Paul Winchell is granted the first patent for an artificial heart. Winchell’s work is aided by Dr. Henry Heimlich, who later develops the Heimlich maneuver to save choking victims. Years later, Winchell signs over his patent rights to Dr. Kolff at the University of Utah.
Kolff Leaves
Dr. Kolff leaves the Cleveland Clinic to start the Division of Artificial Organs at the University of Utah. He continues developing the artificial heart with surgeon Dr. Clifford Kwan-Gett and engineer Thomas Kessler.
The first successful heart transplant is performed in Cape Town, South Africa, by Dr. Christiaan Barnard.
Heart Implantation
Dr. Denton Cooley at the Texas Heart Institute becomes the first heart surgeon to implant an artificial heart in a human subject. The patient lives on the artificial heart, designed by Dr. Domingo Liotta, for 64 hours, but dies 32 hours after transplantation of a donor heart.
New Joinees
Three important figures join Dr. Kolff’s team: veterinarian Don Olsen (leads the animal implants), medical engineer Robert Jarvik (designs various artificial hearts) and surgeon Dr. William DeVries (leads the transition from animal implants to human implants).
Tony
Calf “Tony” lives 30 days on an early Kolff Total Artificial Heart (TAH).
Abebe
Calf “Abebe” lives for 184 days on the Jarvik 5 TAH.
Alfred Lord Tennyson
Calf “Alfred Lord Tennyson” lives for 268 days on the Jarvik 5 TAH.
Dr. Kolff submits a request to the FDA to implant a TAH into a human subject.
Human Implantation
On December 2, the Jarvik 7 is implanted into 61-year-old dentist Dr. Barney Clark, who lives for 112 days. The surgery is led by Dr. DeVries and Dr. Lyle Joyce.
Symbion, Inc.
Dr. Kolff steps down from the board of Kolff Medical, manufacturer of artificial hearts in Utah, including the Jarvik 7. Kolff Medical is renamed Symbion, Inc. on the initiative of Dr. Robert Jarvik, CEO of Kolff Medical at the time.
Human Implantation
William J. Schroeder becomes the second human recipient of the Jarvik 7 and survives 620 days before dying of a lung infection. At the time, this was the longest that anyone had survived with an artificial heart.
Phoenix heart
Dr. Jack Copeland at University Medical Center (UMC) in Tucson, Ariz., implants a prototype artificial heart, known as the Phoenix heart, in a patient who had rejected a recently transplanted heart. The patient, 33-year-old Michael Creighton, lived on the Phoenix heart for 11 hours, but died 60 hours after transplantation of a second donor heart.
Jarvik 7
Dr. Copeland becomes the first surgeon to successfully use the Jarvik 7 as a bridge to human heart transplant. His patient Michael Drummond, 25, lives nine days on the Jarvik 7 before receiving a donor heart.
Closed Symbion, Inc
The FDA closes Symbion, Inc. operations due to violations of FDA guidelines and regulations. The Investigational Device Exemption (IDE) for the clinical study of the TAH is withdrawn.
CardioWest Technologies, Inc.
To save the TAH technology, UMC and MedForte Research Foundation form a new corporation and joint venture, CardioWest Technologies, Inc. Symbion, Inc. transfers the Jarvik 7 technology to UMC, where the Jarvik 7 is subsequently renamed the CardioWest™ Total Artificial Heart.
Clinical Study
UMC initiates a new FDA IDE clinical study of the Total Artificial Heart.
CardioWest Total Artificial Heart
The 10-year, IDE pivotal clinical study of the CardioWest Total Artificial Heart begins at five centers.
SynCardia Systems, Inc.
SynCardia Systems, Inc. is formed by interventional cardiologist Dr. Marvin J. Slepian, biomedical engineer Richard G. Smith, MSEE, CEE, and cardiothoracic surgeon Dr. Jack Copeland with private funding to continue the IDE clinical study with a goal of achieving commercial approval of the CardioWest Total Artificial Heart.
Clinical Study Completed
The pivotal clinical study of the CardioWest Total Artificial Heart is completed.
FDA Approval
The CardioWest Total Artificial Heart receives FDA approval, becoming the first TAH to do so. The official name given to the device through the FDA approval process is the SynCardia temporary CardioWest™ Total Artificial Heart.
CMS Approval
The Centers for Medicare & Medicaid Services (CMS) reverses its 1986 national non-coverage policy for artificial hearts and approves reimbursement for the SynCardia TAH when implanted as part of an FDA study that meets CMS specifications.
CMS Reimbursement
CMS issues its final decision to reimburse the SynCardia TAH through the highest paying Diagnostic Related Group codes, plus new technology add-on payments.
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