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Artificial Heart Timeline

 


   
1911 shim 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. shim

Dr. William Kolff - 1911

Dr. Willem Kolff*


1931   Dr. Kolff enters Leiden University to study medicine, earns his 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

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 five children and begins work at Cleveland Clinic as a research assistant.  

Cleveland Clinic Morning Meeting

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

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 Dr. Clifford Kwan-Gett and engineer Thomas Kessler, who work to improve the artificial heart design begun in Cleveland.

 

Dr. 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 Dr. Kolff's team: veterinarian Don Olsen (leads the implantation experiments on animals), medical engineer Robert Jarvik (designs various artificial heart types) and surgeon Dr. William DeVries (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'

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 Dr. DeVries and Dr. Lyle Joyce.  

Dr. Barney Clark lived for 112 days

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.    

1984   William J. Schroeder was one of the first recipients of an artificial heart at the age of 52. On Nov. 25, 1984, Schroeder became the second human recipient of the Jarvik 7. The transplant was performed at Humana Heart Institute International in Louisville, Ky., by Dr. DeVries. He died on Aug. 7, 1986, of a lung infection, 620 days after receiving the Jarvik 7. This was the longest that anyone had survived with an artificial heart at that time. The headstone marking Schroeder's grave is made of black granite in the shape of two overlapping hearts. One is laser engraved with an image of the Jarvik 7.    

1985  

March: 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. Michael Creighton, 33, lived on the Phoenix heart for 11 hours, but died 60 hours after transplantation of a second donor heart.

August: Dr. Copeland becomes the first surgeon to successfully use the Jarvik 7 Total Artificial Heart as a bridge to human heart transplant. Michael Drummond, 25, lives nine 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 drive.

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

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, 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.    

1997   The Total Artificial Heart receives the CE Mark for Europe and Health Canada approval.    
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.   2001-syncardia-systems

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 CardioWest™ Total Artificial Heart

SynCardia temporary
Total Artificial Heart


2006   The European portable driver receives the CE Mark for powering the SynCardia Total Artificial Heart in Europe.  

Mr. Potiron leavesUniversity Hospital of Nantes in France on the Excor portable driver to enjoy life at home.

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. 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.

 

 

 

Companion Driver System, CE- approved for use in Europe. It is not FDA-approved for use in the U.S.

The Companion Driver System

 


2010  

March: The Freedom portable driver receives the CE Mark to power the SynCardia Total Artificial Heart in Europe. SynCardia also receives approval from the FDA to conduct an IDE clinical study of the Freedom portable 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.

 

July 1: Michael Garippa joins SynCardia as president.

 

August 5: St. Vincent's Hospital in Sydney performs Australia's first implant of the Total Artificial Heart.

 

September 1: Italian Total Artificial Heart patient Pietro Zorzetto surpasses 1,000 days of support with the Total Artificial Heart.

 

September 30: Ege University in Izmir performs Turkey's first implant of the Total Artificial Heart.

 

 

The Freedom portable driver

The Freedom portable driver

The Freedom portable driver

French Total Artificial Heart patient Eric Quantin goes fishing with his Freedom portable driver in his backpack.

The Freedom discharge driver is an investigational device, limited by U.S. and EU law to investigational use.

Russian Total Artificial Heart patient Tatyana (left) visits her newborn grandson and daughter at home using the Freedom portable driver.


 


2011  

January 20: Marcela Padilla becomes the first female Total Artificial Heart patient in the U.S. to be discharged from the hospital using the Freedom portable driver.

 

February 22: Fast Company ranks SynCardia #20 among the world's "50 Most Innovative Companies."

 

May 17: SynCardia President Michael Garippa is named CEO.

 

May 20: Omer Bayrak becomes the first Total Artificial Heart patient in Turkey to be discharged from the hospital using the Freedom portable driver.

 

May 22: Texas Children's Hospital becomes the first pediatric hospital to implant the Total Artificial Heart.

 

June 9: Papworth Hospital in Cambridge performs the United Kingdom's first implant of the Total Artificial Heart.

 

August 2: Matthew Green becomes the first Total Artificial Heart patient in the United Kingdom to be discharged from the hospital using the Freedom portable driver.

 

August 31: Jordan Merecka becomes the first pediatric Total Artificial Heart patient to be discharged from the hospital using the Freedom portable driver.

 

September 9: Pietro Zorzetto, the world's longest supported Total Artificial Heart patient, receives his heart transplant after 1,374 days (nearly four years) of support.

 

October 13: SynCardia is named "Arizona Bioscience Company of the Year" by the Arizona BioIndustry Association (AZBio)

 

November: SynCardia forms SynCardia Systems Europe GmbH in Bad Oeynhausen, Germany, to address growing demand for the Total Artificial Heart in the European market.

 

November 30: Forbes ranks SynCardia #77 on its annual list of "America's Most Promising Companies."

 

December 29: Nikola Gašpic becomes the first Total Artificial Heart patient in Slovenia to be discharged from the hospital using the Freedom portable driver.

 

 

Marcela Padilla was the first female patient in the U.S. to be discharged home using the Freedom driver.

Marcela Padilla was the first female patient in the U.S. to be discharged home using the Freedom portable driver.

 

Fast Company ranked SynCardia #20 among the world's 50 Most Innovative Companies.

Fast Company ranked SynCardia #20 among the world's "50 Most Innovative Companies."

 

Jordan Merecka, pictured with his mother Suzanne, was the first pediatric patient to be discharged home using the Freedom driver.

Jordan Merecka, pictured with his mother Suzanne, was the first pediatric patient to be discharged home using the Freedom portable driver.


2012  

February 8: SynCardia CEO/President Michael Garippa is named Chairman.

 

February 10: The 1,000th implant of the Total Artificial Heart is performed at University of Arizona Medical Center.

 

March 2: The U.S. Food and Drug Administration (FDA) approves a Humanitarian Use Device (HUD) designation for the Total Artificial Heart to be used for destination therapy in addition to its current approval as a bridge to transplant.

 

April 24: SynCardia completes the minimum enrollment required by the FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom portable driver when the 30th Total Artificial Heart patient is discharged from the hospital.

 

June 18: SynCardia is honored with two Gold Stevie® Awards at the 10th Annual American Business Awards for "Company of the Year – Health Products and Services" and "Most Innovative Company of the Year – up to 100 Employees."

 

October: The number of patients supported by the Freedom portable driver worldwide surpasses 100.

 

November 13: SynCardia wins the Nextrio Innovation through Technology Award for the Freedom portable driver as part of the Copper Cactus Awards presented by the Tucson Chamber of Commerce.

 

November: SynCardia wins two Best in Biz Awards. The Freedom portable driver is selected as the Gold winner for "Product of the Year" and SynCardia Chairman/CEO/President Michael Garippa is honored as the Silver winner for "Executive of the Year."

 

December 5: The 1,100th implant of the Total Artificial Heart is performed.

 

December 31: SynCardia finishes 2012 with a record 125 implants of the Total Artificial Heart performed at more than 50 SynCardia Certified Centers worldwide.

 

 

SynCardia Chairman/CEO/President Michael Garippa with the two Gold Stevie® Awards given to SynCardia at the 10th Annual American Business Awards.

SynCardia Chairman/CEO/President Michael Garippa with the two Gold Stevie Awards given to SynCardia at the 10th Annual American Business Awards.

 

 

 

 

 

Copper Cactus Award SynCardia

SynCardia wins the Nextrio Innovation through Technology Award for the Freedom portable driver as part of the Copper Cactus Awards presented by the Tucson Chamber of Commerce.



2013  

January 15: The FDA approves a Humanitarian Use Device (HUD) designation for the 50cc Total Artificial Heart to be used for destination therapy in patients who are not eligible to receive a heart transplant.
›› View Press Release

 

January 30: The FDA approves a Humanitarian Use Device (HUD) designation for the 50cc Total Artificial Heart to be used for the treatment of biventricular heart failure in pediatric patients with a Body Surface Area (BSA) that can sufficiently accommodate the device (i.e. between 1.2 and 1.7m²).
›› View Press Release

 

February 4: At 74 years old, Bob Phillips becomes the oldest Total Artificial Heart patient to leave the hospital using the Freedom portable driver when he is discharged from Penn State Hershey Medical Center.
›› View Press Release

 

February 6: Forbes ranks SynCardia on its annual list of "America's Most Promising Companies" for the second year in a row, moving up eight spots to #69.
›› View Press Release

 

February 14: SynCardia submits a premarket approval supplement to the FDA requesting commercial approval of the Freedom portable driver in the U.S.

 

February 22: The 500th U.S. implant of the Total Artificial Heart is performed.
›› View Press Release

 

April 24 - 27: More than 20 SynCardia Certified Centers and more than 70 authors presented a record number of abstracts discussing the SynCardia temporary Total Artificial Heart at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) in Montreal, Canada.
›› View Press Release

 

April 25: World-renowned heart surgeon and SynCardia co-founder Jack G. Copeland, MD, was awarded the prestigious Pioneer in Transplantation award at the annual ISHLT meeting in Montreal.
›› View Press Release

 

June: U.S. News & World Report named seven SynCardia Certified Centers among the nation's "Best Children's Hospitals" for cardiology and heart surgery in its annual rankings for 2013-2014.
›› View Press Release

 

June 19: The Companion 2 (C2) Driver System, which powers the SynCardia temporary Total Artificial Heart in the hospital, was selected as the Silver Winner in the Critical-Care and Emergency Medicine Products category of the Medical Design Excellence Awards (MDEA).
›› View Press Release

 

August: Over half of the top 50 centers honored in U.S. News & World Report’s “Best Hospitals” list for cardiology and heart surgery for 2013-2014 offer the SynCardia temporary Total Artificial Heart.
›› View Press Release

 

August 21: Doctors at EJK Duisburg in Germany published the first case report detailing use of single-site cannulation with extracorporeal membrane oxygenation (ECMO) to successfully treat adult respiratory distress syndrome in a patient implanted with the SynCardia temporary Total Artificial Heart. The case report was published in the August issue of the Journal of Cardiothoracic Surgery.
›› View Press Release

 

September 24: The 125th implant of the Total Artificial Heart in 2013 is performed.
›› View Press Release

 

October 1: Phoenix Children’s Hospital employed a novel CT-guided, virtual 3D modeling platform to ensure proper fit prior to implanting the SynCardia Heart in a 14-year-old pediatric patient.
›› View Press Release

 

October 20: Smithsonian’s “Bionic Man” TV special and exhibit featured the SynCardia Total Artificial Heart. Scientists and roboticists researched and used the most advanced technology they could find to build the 2013 version of the bionic man, complete with prosthetic body parts and manmade organs. According to the show, the SynCardia Heart is the cyborg's only manmade internal organ that is already saving lives today.
›› View Press Release
›› View Press Release

 

December 31: A new record of 161 SynCardia Total Artificial Heart implants is set in 2013.
›› View Press Release

 

 

50cc and 70cc SynCardia Total Artificial Hearts

The 70cc and 50cc Total Artificial Hearts 

 

 

 

Total Artificial Heart patient Bob Phillips
 

 

 

 

 

 

 

Dr. Jack Copeland, middle
 

 

The Companion 2 Driver System
 

 

See October 1

 

See October 20

See December 31


2014  

January: University of Arizona senior Sandra Gonzalez is the first recipient of the Anna Salazar Memorial Engineering Scholarship presented by SynCardia.
›› View Press Release

 

April 17: SynCardia receives the CE Mark for the SynCardia temporary Total Artificial Heart with SynHall™ valves, providing the company with control over the last key component required for heart manufacturing.
›› View Press Release

 

April - May: Randy Shepherd’s 4.2-mile walk in Pat’s Run on April 26, 2014, in the Phoenix area was more than a test of his endurance. It was part of his training for the most crucial event of his life—a heart transplant. Soon after, Randy shared his story on Reddit, starting an "Ask Me Anything" (AMA) question and answer.
›› View Press Release 4.2-Mile Run
›› View Press Release Reddit's AMA

 

April 30: SynCardia's Freedom portable driver is selected as the Silver Winner at the Edison Awards.

 

FDA approval of Freedom portable driver
June 26: The FDA approves SynCardia’s premarket approval application (PMA) supplement for the Freedom portable driver.

 

July 2: SynCardia receives FDA approval for the SynCardia temporary Total Artificial Heart with SynHall™ valves.

 

July 28: SynCardia receives Health Canada approval for the SynCardia temporary Total Artificial Heart with SynHall™ valves.

 

September 15: Arizona's "Tin Man" gets a donor heart after 15 months on the SynCardia Total Artificial Heart.
›› View Press Release

 

November: University of Arizona junior Justine Bacchus receives the Anna Salazar Memorial Engineering Scholarship presented by SynCardia.
›› View Press Release

 

 

SynCardia Total Artificial Heart with SynHall valves.

 

Randy and Tiffany Shepherd before walking in Pat's Run.

 

freedomtimelinefda

Freedom portable driver

 


2015  

January: The FDA approves the SynCardia Total Artificial Heart for a destination therapy study.
›› View Press Release

 

February: Digital magazine HP Matter features video “Lifesaving Tech: Living with an Artificial Heart,” with Randy Shepherd and Christopher Larsen, two Arizona men who were implanted with the SynCardia Total Artificial Heart as a bridge to a donor heart transplant.
›› View Press Release and Watch Video

 

March: FDA approves Investigational Study for new, smaller SynCardia Total Artificial Heart - The 50cc heart is the smaller version of the 70cc SynCardia Heart, which is FDA, Health Canada and CE mark approved. It is designed for implantation in most women, smaller men and many adolescents with end-stage biventricular heart failure.
›› View Press Release

 

April: 1st U.S. patient discharged from the hospital without a human heart celebrates fifth anniversary of going home with the Freedom portable driver.
›› View Press Release

SynCardia is honored with the 2015 Medical Company of the Year Award from AZ Business Magazine
›› View Press Release

 

August: The start of the SynCardia Total Artificial Heart destination therapy clinical study wins the Edison Awards’ top honor
›› View Press Release

 

 

 

The winter 2015 HP Matter issue on health care technology features a 3:35 video of two Arizona men who were implanted with the SynCardia Total Artificial Heart.

The 70cc (left) and 50cc (right) SynCardia temporary Total Artificial Hearts. SynCardia has received FDA approval to launch an Investigational Device Exemption study into the effective use of the new 50cc SynCardia Heart.


 

 
 
 

*Images courtesy of Special Collections Department, J. Willard Marriott Library, University of Utah

 

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