totally artificial heart

Topics: Artificial heart, Hospital, Food and Drug Administration Pages: 5 (1139 words) Published: October 12, 2013
Totally Artificial Heart (TAH)
The US government funded a project to create a totally artificial heart in 1964. Bioengineers thought that a fully functional totally artificial heart would have been created within the next 10 years. In 1964 the Liotta TAH was used to bridge the period between the need for a transplant and the provision of a heart from a donor. The totally artificial heart kept the patient alive for 64 hours, at which point the patient received a transplant and died 32 hours later. In 1981 the Akatsu TAH was also used as a bridge heart for a period of 9 days, although the patient dies 9 days after the final transplant this was still an improvement. The Jarvic-7 came along in 1982 and was fitted to the first patient, Barney Clark, in an attempt to replace his heart and he lived for 112 days after the transplant. The second patient to be fitted with the Jarvic-7 TAH was William Schroeder, although he lived for 620 days he still experienced problems with the Jarvic-7 1985 saw the Phoenix TAH used as a bridge heart to a transplant, only to have the patient die 12 hours after the final transplant. 2000; Abiomed will implant a brain-dead person with a new electro-hydaulic heart, as a finale to 10 years of research 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.


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


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.


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


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


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


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.


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...
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