| Tucson,
Ariz. – August 7, 2007 – In 1986,
artificial hearts were new and their use and efficacy
were in question. At that time, Centers for Medicare
& Medicaid Services (CMS) made a national decision
not to provide reimbursement for any artificial hearts.
Two decades later, the CardioWest™
temporary Total Artificial Heart (TAH-t) is the
world’s only FDA approved temporary artificial
heart. More than 650 patients have received a TAH-t,
accounting for more than 100 patient years of life.
On August 1, 2007, CMS
posted a notice to its web site announcing the review
of the non-coverage policy with a final decision due
no later than May 1, 2008.
Today, CMS pays for heart transplants, but not for the
TAH-t, which is used as a bridge to transplant for donor
eligible patients who are near death from end stage
biventricular failure. About half of private insurance
plans now cover the artificial heart.
“Many private insurers use CMS reimbursement decisions
as their benchmark for coverage. A positive decision
will make the artificial heart available to most Americans
who need it through private insurance and CMS,”
explains Rodger
Ford, President and CEO of SynCardia
Systems, Inc. manufacturer of the TAH-t.
TAH-t Doubles Odds of Living Another Year ... Heart
transplant eligible patients, who are near death from
end stage biventricular heart failure, increase their
odds of living another year from 31 percent to 70 percent,
when they are bridged to transplant with the CardioWest
TAH-t, based on a comparison with a set of historical
control patients who were matched to the patients receiving
the artificial heart (New
England Journal of Medicine 2004; 351: 859-867).
###
Media Contact:
SynCardia Systems,
Inc.
Director of Communications
Donald Isaacs
520-955-0660
About the CardioWest™ temporary Total Artificial
Heart
The CardioWest™ TAH‑t is a pneumatic, biventricular, implantable bridge-to-transplant
system for full cardiac replacement, taking the place of the failing heart in
patients at imminent risk of death. The device offers full circulatory support,
the shortest blood path and exposure to artificial surfaces, and the highest level
of cardiac output when compared with other artificial heart systems previously
tested. With the CardioWest™ TAH‑t, patients become better candidates for
eventual transplantation and have post-transplant survival rates equal to that
of non-device cardiac recipients.
About SynCardia Systems
Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement
and assist devices. Its CardioWest™ temporary Total Artificial Heart (TAH‑t)
is designed for severely ill patients with end-stage congestive heart failure.
The device serves as an in-hospital bridge-to-transplantation for patients at
imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on
the Web at http://www.syncardia.com.
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