SynCardia Systems, Inc. - Artificial Heart Timeline

Total Artificial Heart Timeline

The SynCardia temporary Total Artificial Heart is the result of decades of collaboration by hundreds: scientists, physicians, engineers, students and faculty. It is important to mention that many others contributed to the underlying science and technologies that resulted in the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. This timeline begins with Dr. Willem Kolff, the most prolific inventor of artificial organs, including the Total Artificial Heart.

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Art Timeline


1911	On February 14, Willem Johan ‘'Pim' Kolff is born in Leiden, the Netherlands. Kolff would later become the world's most prolific inventor of artificial organs, including the Total Artificial Heart.	Dr. Willem Kolff*

1931	Dr. Kolff enters Leiden University to study medicine, earns M.D. in 1937.

1938	At Groningen University Hospital, Dr. Kolff begins to collaborate with biochemist Robert Brinkman on a prototype for an artificial kidney after witnessing a farmer's son die of total kidney (renal) failure.

1942	While working as a physician at the City Hospital ‘'Engelenbergstichting' in Kampen, Dr. Kolff produces a rotating drum kidney built out of aluminum from a shot down German fighter plane, a 1937 Ford Model T water pump, an enamel tank and 40 meters of cellophane normally used as artificial sausage skin.	Artificial Kidney*

1947	Dr. Kolff begins research on designing a heart-lung machine and an artificial heart.

1950	Dr. Kolff emigrates from the Netherlands with his wife Janke and their 5 children and begins work at Cleveland Clinic as a research assistant.	Cleveland Clinic morning meeting*

1956	Dr. Kolff develops one of the first heart-lung machines.

1957	At Cleveland Clinic, Dr. Kolff and Dr. Tetsuzo Akutsu bring the concept of an artificial heart to reality through a series of animal implants; a dog survives for approximately 90 minutes.	Kolff-Akutsu Heart*

1963	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.

1967	Dr. Kolff leaves Cleveland Clinic to start the Division of Artificial Organs at the University of Utah and to continue his work on the artificial heart. Dr. Kolff brings with him surgeon Clifford Kwan-Gett and engineer Thomas Kessler, who work to improve the artificial heart design begun in Cleveland. Christiaan Barnard performs the first heart transplant in Cape Town, South Africa; the patient lives 18 days.

1969	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.

1971-1979	Three important figures join the Kolff team: veterinarian Don Olsen (leads the implantation experiments on animals), medical engineer Robert Jarvik (designs various artificial heart types) and surgeon William DeVries, M.D. (leads the process of shifting from animal to human implantation).

1973	Calf "Tony" lives 30 days on an early Kolff Total Artificial Heart.

1976	Calf "Abebe" lives for 184 days on the Jarvik 5 Total Artificial Heart.

1981	Calf "Alfred Lord Tennyson" lives for 268 days on the Jarvik 5. Dr. Kolff submits a request to the FDA to implant a Total Artificial Heart into a human being.	Don Olsen with “Alfred Lord Tennyson”*

1982	On December 2, Dr. Kolff’'s Jarvik 7 Total Artificial Heart is implanted into 61-year-old dentist Dr. Barney Clark, who lives for 112 days. The surgery is led by Drs. William DeVries and Lyle Joyce.	Dr. Barney Clark lived for 112 days on the Jarvik 7*.

1983	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 Robert Jarvik, CEO of Kolff Medical at the time.

1985	March: Dr. Jack Copeland at University Medical Center (UMC) in Arizona implants a prototype artificial heart, known as the Phoenix heart, in a patient who had rejected a recently transplanted heart. 33-year-old Michael Creighton lived on the Phoenix heart for 11 hours but died 60 hours after transplantation of a second donor heart. August: Dr. Jack Copeland at University Medical Center (UMC) in Arizona becomes the first surgeon to successfully use the Jarvik 7 Total Artificial Heart as a bridge to human heart transplant. 25-year-old Michael Drummond lives 9 days on the Total Artificial Heart before receiving a donor heart.	L to R: Dr. Mark Levinson, Dr. Jack Copeland, Richard Smith, staff nurse, Michael Drummond and the "Big Blue" Driver. Richard Smith and Dr. Jack Copeland with patient Michael Drummond.

1990	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 Total Artificial Heart is withdrawn.

1991	To save the Total Artificial Heart technology, University Medical Center (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.

1992	UMC initiates a new FDA IDE clinical study of the Total Artificial Heart.

1993	The 10-year IDE pivotal clinical study of the CardioWest Total Artificial Heart begins at five centers.

1998	La Pitie Hospital in Paris performs its 100th implant of the Total Artificial Heart.

2001	SynCardia Systems, Inc. is formed by Dr. Marvin J. Slepian along with biomedical engineer Richard G. Smith, MSEE, CEE and cardiothoracic surgeon Dr. Jack Copeland with private funding to commercialize the CardioWest Total Artificial Heart and to continue the IDE clinical study.

2002	The pivotal clinical study of the CardioWest temporary Total Artificial Heart is completed.

2003	The Heart and Diabetes Center NRW in Bad Oeynhausen, Germany, pioneers the clinical study of the Excor portable driver for powering the Total Artificial Heart. The portable driver enables stable European patients to be discharged from the hospital while they wait for a matching donor heart for transplant.

2004	Findings from the IDE pivotal clinical study of the Total Artificial Heart are published in the New England Journal of Medicine; 79 percent of patients receiving the CardioWest survived to transplant. This was and remains the highest bridge-to-transplant rate for any approved heart device in the world^{^}. October 15: The CardioWest becomes the world's first and only FDA-approved Total Artificial Heart. While originally used as a permanent replacement heart, the Total Artificial Heart is approved for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. The official name given to the device through the FDA approval process is the SynCardia temporary CardioWest™ Total Artificial Heart. ^The pivotal clinical study of the SynCardia Total Artificial Heart used two endpoints: bridged-to-transplant and death. Recent pivotal clinical studies of approved ventricular assist devices state a success rate that includes: patients alive and transplant-eligible at 6 months, patients who recovered and patients who were bridged-to-transplant.	SynCardia temporary Total Artificial Heart

2005	The SynCardia Total Artificial Heart receives the CE Mark (Europe) and Health Canada approval.

2006	The European portable driver receives the CE Mark for powering the SynCardia Total Artificial Heart in Europe.	Mr. Potiron leaves University Hospital of Nantes in France on the European portable driver.

2007	The 700th implant of the Total Artificial Heart is performed by Mayo Clinic Arizona.

2008	May: The Centers for Medicare & Medicaid Services (CMS) reverses its 1986 national non-coverage policy for artificial hearts and approves reimbursement for the SynCardia Total Artificial Heart when implanted as part of an FDA study that meets CMS specifications. July: CMS issues its final decision to reimburse the SynCardia Total Artificial Heart through the highest paying Diagnostic Related Group codes, plus new technology add-on payments.

2009	February 11: Dr. Willem Kolff dies at age 97. June: The 800th implant of the Total Artificial Heart is performed by the Heart and Diabetes Center NRW. October: The Companion Driver System receives the CE Mark for powering the SynCardia Total Artificial Heart in Europe. November: SynCardia submits an application to the FDA to conduct an IDE clinical study of the Freedom™ portable driver. Once approved, the clinical study is designed to demonstrate that stable Total Artificial Heart patients can leave the hospital to wait for a matching donor heart at home.	The Companion Driver System is CE approved for use in Europe. It is not FDA approved for use in the U.S.
2010	March: The Freedom™ portable driver receives the CE Mark to power the SynCardia Total Artificial Heart in Europe. SynCardia also receives conditional approval from the FDA to conduct an IDE clinical study of the Freedom driver in the U.S. May 3: The first Total Artificial Heart patient in the U.S. is discharged from the hospital using the Freedom™ portable driver as part of the IDE clinical study. May 28: The first Total Artificial Heart patient in Europe is discharged from University Hospital of Nantes in France using the Freedom™ portable driver and successfully transplanted a few days later. June 4: The world’s first female Total Artificial Heart patient is discharged from the Bakoulev Scientific Center for Cardiovascular Surgery in Moscow, Russia using the Freedom™ portable driver.	The Freedom™ portable driver is an investigational device, limited by United States law to investigational use. French Total Artificial Heart patient Eric Quantin goes fishing with his Freedom portable driver in his backpack. Russian Total Artificial Heart patient Tatyana (left) visits her newborn grandson and daughter at home using the Freedom portable driver.