SynCardia Systems, LLC, headquartered in
Tucson, Arizona
Tucson (; ; ) is a city in Pima County, Arizona, United States, and its county seat. It is the second-most populous city in Arizona, behind Phoenix, Arizona, Phoenix, with a population of 542,630 in the 2020 United States census. The Tucson ...
, was founded in 2001 and is the sole manufacturer and provider of the world's only clinically proven and commercially approved Total Artificial Heart.
The SynCardia temporary
Total Artificial Heart (TAH) has been in clinical use for more than 35 years.
History
SynCardia was founded in 2001 by cardiothoracic surgeon
Jack G. Copeland, MD; biomedical engineer Richard G. Smith, MSEE, CCE; and interventional cardiologist Marvin J. Slepian, MD; with Steven Langford BSEE, as General Manager. Today, SynCardia is a wholly owned subsidiary of Picard Medical and remains the sole manufacturer and provider of the world’s only commercially approved Total Artificial Heart. In clinical use for more than 35 years, the SynCardia temporary Total Artificial Heart (TAH-t) is the most widely used and extensively studied Total Artificial Heart in the world.
In 2004, the
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
approved the SynCardia TAH (formerly known as the "CardioWest temporary Total Artificial Heart”) as a bridge to donor
heart transplant
A heart transplant, or a cardiac transplant, is a surgical transplant procedure performed on patients with end-stage heart failure when other medical or surgical treatments have failed. , the most common procedure is to take a functioning heart ...
in cardiac transplant-eligible candidates at risk of imminent death from end-stage biventricular failure.
SynCardia's products include the original 70cc TAH; the newer, smaller 50cc TAH, designed to fit patients of smaller stature, including more women and adolescents; the Companion 2 (C2) Hospital Driver, which provides pneumatic power to the TAH from implant through patient recovery in the hospital; and the Freedom Portable Driver, a smaller, portable pneumatic pump for the TAH that allows stable patients who meet discharge criteria to enjoy life at home while they wait for a matching donor heart.
[
In addition to its being used as a bridge to transplant in the U.S., Canada and Europe, the 70cc TAH has supported several patients as a destination therapy in adult patients who are not eligible for transplant. The longest patient supported by the SynCardia Total Artificial Heart on a person who became not eligible for transplant was over 6 years and 9 months. He lived a near normal lifestyle at home with his wife. The smaller 50cc TAH is currently approved for use as a bridge to transplant for both pediatric and adult patients.][
In September 2016, SynCardia was acquired by Versa Capital Management, LLC, a Philadelphia-based private equity investment firm and then was acquired by Piccard Medical in September 2021, which has provided additional financial and operational resources.]
See also
* Artificial heart
An artificial heart is a artificial organ, device that replaces the human heart, heart. Artificial hearts are typically used as a bridge to heart transplantation, but ongoing research aims to develop a device that could permanently replace the ...
* Artificial heart valve
An artificial heart valve is a one-way valve implanted into a person's heart to replace a heart valve that is not functioning properly ( valvular heart disease). Artificial heart valves can be separated into three broad classes: mechanical he ...
* Wayne Griffin
* Jack G. Copeland
References
{{Reflist, 3
External links
Company website
Cardiology
Implants (medicine)
Prosthetic manufacturers
Companies based in Tucson, Arizona
Medical technology companies of the United States