CMS Encourages SynCardia to Submit New Technology Add-On
Application
If and When Freedom™ Portable Driver Undergoing Clinical
Study Receives FDA Approval
TUCSON, Ariz. – Aug. 26, 2010 — On
Aug. 16, the Centers for Medicare and Medicaid Services (CMS)
published its
FY 2011 Hospital Inpatient Prospective Payment System (PPS) final
rule, approving new technology add-on payments of up to $53,000
for the SynCardia temporary Total Artificial Heart (TAH-t) through
FY 2011. The decision is effective Oct. 1, 2010.
CMS stated in its ruling that, “Commenters supported our
proposal to continue add-on payments for the TAH-t… We agree
with the commenters that, for patients with biventricular heart
failure, the TAH-t continues to represent a substantial clinical
improvement.”
SynCardia Systems, Inc., manufacturer of the Total Artificial
Heart, informed CMS of the company’s recent use of the 13.5
lb Freedom™ portable driver, which provides increased
mobility so that stable patients who are eligible may leave the
hospital while waiting for a donor heart. SynCardia asserted that
this new driver further demonstrates that the Total Artificial
Heart represents a substantial clinical improvement.
SynCardia also noted that the use of this portable driver
increased the operating costs of the Total Artificial Heart and
requested that the new technology add-on payment be increased
accordingly. However, CMS noted that because the Freedom driver is
undergoing an Investigational
Device Exemption (IDE) clinical study and is not FDA-approved,
it is unable to increase the new technology add-on payments for FY
2011.
CMS stated in its ruling, “We would encourage the
manufacturer to submit a new technology add-on payment application
if and when it expects to receive FDA approval for… the
Freedom driver.”
SynCardia’s Total Artificial Heart has been approved for
new technology add-on payments since FY 2009. It is the
world’s only FDA, Health Canada and CE approved Total
Artificial Heart.
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About SynCardia Systems, Inc.
SynCardia Systems, Inc. is the Tucson-based manufacturer of the
world’s only FDA, Health Canada and CE approved Total
Artificial Heart: the SynCardia temporary Total Artificial Heart.
There have been more than 850 implants of the Total Artificial
Heart, accounting for more than 200 patient years of life on the
device.
Originally used as a permanent replacement heart, the Total
Artificial Heart is currently approved as a bridge to human heart
transplant for people dying from end-stage biventricular
failure. The Total Artificial Heart is the only device that
provides immediate, safe blood flow of up to 9.5 L/min through
both ventricles.
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