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Company Timeline

Date — Event

  • 1988 — Dr. Robert Jarvik founds Jarvik Research, Inc. in New York, NY, to conduct research and development on advanced concepts for miniature artificial hearts. Marilyn vos Savant, the co-founder, becomes the company’s CFO.
  • 1990 — Following development and bench-testing of many preliminary designs, the first calf implants are conducted by Dr. O.H. Frazier at the Texas Heart Institute.
  • 1992 — Jarvik Research receives Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH) and from New York State.
  • 1993 — Jarvik Research begins animal tests in collaboration with Dr. Eric Rose and Dr. Mehmet Oz at Columbia University in New York.
  • 1994 — Jarvik Research begins collaboration with Dr. Stephen Westaby in surgical research at Oxford University in England.
  • 1995 — NIH funds a major 5-year contract to develop the Jarvik 2000 for long-term use. Dr. Jarvik serves as the Principal Investigator; Transicoil, Inc., an aerospace technology firm as the prime contractor; and Dr. Frazier at Texas Heart Institute as the co-investigator, responsible for In Vivo testing. The goal of the program, to develop a highly reliable innovative Left Ventricular Assist System, is achieved in the following five years.
  • 1997 — In preparation for clinical pilot studies in patients, Jarvik Research, Inc. is renamed Jarvik Heart, Inc.
  • 1998 — Jarvik Heart, Inc. submits its first pre-IDE document to the Food and Drug Administration (FDA) detailing the Jarvik 2000 FlowMaker® and the planned protocol for its initial human application. Over the following two years, additional testing and documentation is completed to satisfy the FDA’s requirements.
  • 1999 — Jarvik Heart, Inc. requests regulatory approval in England to investigate the Jarvik 2000 heart for lifetime use. The Medical Devices Agency (MDA) permits the study to begin late in the year, but a suitable patient candidate is not identified until the following summer.
  • March, 2000 — The FDA grants an Investigational Device Exemption (IDE) for bridge-to-transplant use of the Jarvik 2000 heart at the Texas Heart Institute. Initially patients must remain in the hospital until a donor is found.
  • April, 2000 — The first Jarvik 2000 patient under the IDE protocol, Lois Spiller receives the Jarvik 2000 heart. Dr. Frazier performs the landmark surgery joined by Dr. Westaby from Oxford, Dr. Denton Cooley, and Dr. Jarvik. Ms. Spiller is supported for 78 days until a donor is found. She is successfully transplanted, rehabilitated, and returned home.
  • June, 2000 — The first lifetime use patient, Peter Houghton, receives the Jarvik 2000 lifetime use model with an infection resistant behind-the-ear power connector. Dr. Frazier and Dr. Jarvik join Dr. Westaby in the historic surgery. Though Mr. Houghton has bleeding complications following surgery, he recovers fully and is rehabilitated to excellent health. In subsequent years, he travels widely in Europe and the United States, ranging from hiking in the canyons of southern Utah to walking mountain trails at high altitude in the Swiss alps. He writes two books and works with charitable fundraising for artificial heart research in England.
  • 2001 — Jarvik Heart establishes several new investigational centers in Europe and adds the Cleveland Clinic to its US pilot study. By year end, 32 patients have been implanted in five countries.
  • April, 2004 — Jarvik Heart and its collaborators win a $5 million NIH contract to develop a further miniaturized version of its successful Jarvik 2000 heart pump for use in children. The company begins full-time development of the pediatric pump.
  • August, 2004 — The Jarvik 2000 FlowMaker® sets a new world record when Peter Houghton logs his 1518th day of life-saving support by the mechanical heart. Mr. Houghton is the first cardiac-assist device patient ever to live so long supported by a single assist device.
  • March, 2005 — Jarvik Heart receives conditional approval from the FDA to begin a pivotal trial of the Jarvik 2000 FlowMaker® for bridge-to-transplant use.
  • May, 2005 — Jarvik Heart receives CE Mark certification for the Jarvik 2000 FlowMaker®, providing approval for the device to be marketed and sold throughout the European Union, thereby making it available to patients more widely and at earlier stages of heart failure.
  • December, 2007 — Peter Houghton, who was supported by the Jarvik 2000 for seven and a half years, dies of acute renal failure. A close friend of Jarvik Heart, Inc., he will be dearly missed by all.
  • September, 2012 — FDA grants approval of an Investigational Device Exemption to begin the Randomized Evaluation of Longterm Intraventricular VAD Effectiveness (RELIVE) trial with the Jarvik 2000 Ventricular Assist Device model using the post-auricular (behind-the-ear) connector.
  • November, 2013 — Shonin approval is granted following the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of data on Japanese and US clinical trials with the device. In Japan, where there is an extended waiting time for donors, patients have been supported long term by the Jarvik 2000, for up to four years, and then have been successfully transplanted once a donor heart has become available.