Over the past 10 years there have been major advancements in medical technology. We have digital diagnostic imaging, electronic medical records, and blood pressure monitor’s for your iPhone. With the invention of digital diagnostic imaging software and hardware, comes greater ease of use for patients and physicians alike. Finally we have the Jarvik Artificial Heart, what is now known as the SynCardia Temporary CardioWest Total Artificial heart, and the topic of this post. More specifically, I will be discussing the history of the device. This device was originally developed by Dr. Willem Kolff and Kolff Medical, but the company’s name changed for reasons I will explain later.
We are going to start with 1971. In the 9 years between 1971 and 1979 there were a few additions to the Kolff Medical team, including Wiliiam Devries, MD, Surgeon; Don Olsen, Veterinarian; and Robert Jarvik, Engineer. Each of these individuals were responsible for a specific part in the development and testing of the medical device. Dr. Robert Jarvik was credited with designing the artificial heart, Dr. Jarvik was responsible for designing the implant and the apparatus that the implant attaches to, Dr. Don Olsen was responsible for leading the animal implantation effort, and Dr. William DeVries was responsible for leading the effort of transitioning from animals to humans.
It’s time for a time warp to the 1980′s. In 1981 Dr. Kolff submitted a request to the United States of America’s Food and Drug Administration (the FDA) to begin implanting in humans. In 1982, a Calf by the name of Alfred Lord Tennyson lived for 268 days on the Jarvik 5. Later that year on December 2nd, Dr. Barney Clark, received the total artificial heart and survived 112 days.
A few years later, Dr. Kolff steps down from the board of Kolff Medical and the company is subsequently renamed to Symbion, Inc. Sadly, though, it didn’t last all that long; because of certain FDA violations, the company was forced to close and its FDA Investigational Device Exemption Study was withdrawn. In order to save the artificial heart technology, University Medical Center and MedFore Research Foundation formed a new joint venture named CarioWest Technologies Inc. and the Jarvik 7 technology was transferred to University Medical Center. Subsequently, the Jarvik 7 was renamed to the CardioWest Total Artificial Heart. Finally the 10-year Investigational Device Exemption Study begins at five different centers.
Yet another time warp brings us to the 21st century. In 2001, SynCardia System, Inc. was formed by Dr. Marvin J. Slepian along with biomedical engineer Richard G. Smith, MSEE, and cardiovascular surgeon Dr. Jack Copeland with private funding to commercialize the the total artificial heart. Remember the 10-year FDA IDE study I mentioned earlier? Well that wrapped up and on October 15, the CardioWest Total Artificial Heart becomes the first and only FDA approved total artificial heart. The final name the was given to the device through FDA approval was the SynCardia Temporary CardioWest Total Artificial Heart, also known as “Big Blue”.
Now fast forward to November of 2009; SynCardia submits an application to the FDA to conduct an Investigational Device Exemption study of the Freedom Discharge driver. This device is the smaller companion to Big Blue. Big Blue allows doctors to have finer control over the the implant. The Freedom Discharge driver allows a patient to have more freedom. Instead of being tethered to a four-hundred pound machine, the patient is hooked up to a driver that weighs no more than fifteen pounds. The driver allows the patient to more easily complete day-to-day tasks, but restricts the doctors’ direct control of the device. Finally, the FDA approved the IDE study of the Freedom Discharge driver and that study is still going on this day.
A milestone was recently hit; the 1000th implant of the SynCardia Temporary CardioWest Total Artificial Heart was completed on February 10, 2012. Sadly, though, the father of the artificial heart, Dr. Williem Kolff, passed away in 2011 at the age of 97. He will be sorely missed, but his legacy will live on with the artificial heart.
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