| Tucson, Ariz. – May 20, 2008 – SynCardia recently released its 2007 Annual Report detailing three strategic benchmarks the company intends to surpass in 2008. 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.
The Companion
Discharge Caddy is
designed for mobility
around the hospital
and for discharge.
“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 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.
“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.
CardioWest patient Henno
(Hans Walter Thrun) at
home with the CE
approved European
portable driver.
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, accounting for more than 125 patient years of life on the artificial heart.
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 for any heart device in the world.
Media Contact:
SynCardia Systems, Inc.
Director of Communications
Don Isaacs
Cell: 520-955-066
|
