2008 SynCardia Annual Shareholders Meeting Projects Use of CardioWest™
Artificial Heart to Quadruple Following SynCardia’s
Achievement of 2008 Benchmarks
1st of 3 Strategic Benchmarks, Medicare Reimbursement, Achieved May 1
TUCSON, Ariz. (Business Wire EON) May 28, 2008 --
On May 28, SynCardia Systems, Inc.
will be holding its annual shareholders meeting at the Westin La Paloma
Resort. SynCardia’s senior management team
will be detailing three strategic benchmarks the company intends to
surpass in 2008, which were recently released in its 2007
Annual Report. Benchmark achievement is projected to increase the
number of patients benefiting from the CardioWest™
temporary Total Artificial Heart (TAH-t) by 400% in the following 24
months.
“Insurance coverage by almost all U.S. plans,
combined with a discharge driver that allows stable patients to recover
at home, will quadruple the number of people we can help,”
explained Rodger
Ford, President and CEO of SynCardia. “There
is no better bridge-to-transplant than the CardioWest artificial heart.
It saves more lives.”
Originally designed as a permanent replacement heart, the CardioWest
artificial heart is currently approved as a bridge-to-transplant for
patients who are days, if not hours from death from end stage
biventricular failure. Their survival is dependent upon receiving an
immediate matching donor heart, or a CardioWest artificial heart as a
bridge to human heart transplant.
Benchmark #1: Medicare/Medicaid Reimbursement
SynCardia achieved the first benchmark on May 1, 2008, when the Centers
for Medicare and Medicaid Services (CMS) reversed its 1986 non-coverage
policy for artificial hearts and approved
reimbursement for the CardioWest artificial heart.
“Medicare’s final
decision means that nearly all insured Americans who need the artificial
heart will be able to get one,” said Ford. “Most
of the insurers who didn’t cover the
artificial heart use CMS decisions as their benchmark for coverage.”
Benchmark #2: Stable U.S. CardioWest Patients Will Be Able to Recover
at Home
Since July 17, 2006, stable CardioWest patients in Europe have been able
to recover at home while they wait for a donor heart, made possible by
the CE
approved European portable driver. In the U.S., CardioWest patients
are currently confined to the hospital for 30 to 90 days while waiting
for a matching donor heart for transplant.
Later this year, SynCardia will submit an application to the FDA to
conduct an IDE clinical study of the Companion
Driver System at 22 U.S. CardioWest certified centers. The Companion
Driver is designed for use in both the hospital and for discharge.
Benchmark #3: Worldwide Availability of the Companion Driver System
Today, there are only 38 FDA and CE approved CardioWest operating room
drivers available worldwide. This restricts the number of patients who
can be implanted with the CardioWest artificial heart. Availability of
the new Companion Driver System will remove this constraint.
Once the application for the FDA clinical study of the Companion Driver
System is submitted, and if approved, SynCardia will have the capacity
to produce up to 40 Companion Driver Systems per month through its U.S.
OEM.
The Companion Driver System is intended to be serviced by replacement,
with no on-site repair service required. The drivers will be supplied
and returned through Federal Express.
Read more in SynCardia’s
2007 Annual Report
The CardioWest artificial heart is the first and only FDA, Health
Canada and CE Mark approved temporary Total Artificial Heart in the
world. There have been more than 715 implants of the CardioWest
artificial heart, accounting for more than 125 patient years of life on
the device.
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 artificial heart survived to transplant. This is
the highest bridge-to-transplant rate of any approved heart device in
the world.
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5695344
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