Healthcare Industry News: SynCardia
News Release - April 9, 2008
World's First 4-lb Discharge Driver For Powering CardioWest Artificial Heart Unveiled at ISHLT in BostonBOSTON--(HSMN NewsFeed)--On April 9-12, SynCardia Systems, Inc., manufacturer of the CardioWest™ temporary Total Artificial Heart (TAH-t), is unveiling the prototype of its new four-pound Companion II Driver, the next generation in its Companion Driver System series, at the 28th annual meeting of the International Society for Heart and Lung Transplantation (ISHLT).
“Weighing only four pounds, the Companion II is intended to be the smallest pneumatic driver for the artificial heart in the world,” said SynCardia President and CEO Rodger Ford. “You’ll never notice patients with the Companion II because it is designed to disappear into a fanny pack.”
Since July 17, 2006, stable CardioWest patients in Europe have enjoyed a much better quality of life than CardioWest patients in the U.S. because of the CE approved portable driver. Discharge drivers allow stable artificial heart patients to shop, travel and enjoy a quality of life comparable to people with human hearts. Discharge eliminates most in-hospital costs while these stable patients wait for a donor heart at home.
Today, U.S. CardioWest patients are confined to the hospital while they wait for a heart transplant because the only FDA-approved driver is the hospital-based, 400-pound “Big Blue.”
SynCardia will submit an application to the FDA this year to conduct an IDE clinical study of the Companion Drive System at 22 U.S. hospitals. SynCardia has been working with the FDA and CMS for more than a year to bring this new technology to its patients. The first Principal Investigator’s Meeting is April 10, at ISHLT.
The Companion Drive System is designed to be docked into the Companion Hospital Cart for use in the operating room and intensive care unit. Once the CardioWest artificial heart patient is stable, the Drive Unit is designed to be re-docked into the Companion Discharge Caddy for mobility around the hospital and recovery at home.
“The Companion Driver family offers us the opportunity to address the deficiencies in the spectrum of mechanical circulatory support,” Ford said. “These drivers are intended to support not only the world’s only temporary Total Artificial Heart, but also the SynCardia family of pulsatile devices that are currently under development.”
At ISHLT, SynCardia is presenting prototypes of the 10cc VAD, 30cc VAD and 50cc artificial heart currently being developed, along with the Companion II Driver.
The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. Originally designed as a permanent replacement heart, the CardioWest is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure. These patients are often days, if not hours from death. Their survival is dependent upon receiving a matching donor heart, or a CardioWest artificial heart as a bridge-to-transplant.
In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the CardioWest survived to transplant. This is the highest bridge-to-transplant rate for any heart device in the world. There have been more than 715 implants of the CardioWest, accounting for more than 125 patient years of life on the artificial heart.
Source: SynCardia Systems
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