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1st Findings on Exercise Performance with SynCardia’s Total Artificial Heart Published in The Journal of Heart and Lung Transplantation

November 10, 2011 By AxoGen, Inc.

TUCSON, Ariz.
– Nov. 10, 2011 – In the November issue of The Journal of Heart and
Lung Transplantation (JHLT), Virginia Commonwealth University (VCU) Medical Center
in Richmond
published the first findings demonstrating that physical exercise and
measurable rehabilitation are feasible with the SynCardia temporary Total
Artificial Heart. Read
article

The single-center,
retrospective study measured blood pressure (BP) response during exercise,
exercise duration and change in tolerated exercise workload over an 8-week
period. The study included 37 patients implanted with SynCardias Total
Artificial Heart (TAH) and 12 patients implanted with the HeartMate II left ventricular
assist device (LVAD).

Total Artificial Heart patients began physical
rehabilitation at a median of 5 days and treadmill exercise a median of 19 days
after implant, with increased exercise intensity and duration over time. Mean
arterial BP did not change with exercise
in patients with the Total Artificial Heart but did increase in those with
an LVAD.

“During circulatory support with a TAH, the BP response to
exercise was blunted,” the studys authors concluded. “However, aerobic
exercise training early after device implantation was found to be safe and
feasible in a supervised setting.”

Patients who participated in physical therapy early tended
to have shorter waiting periods for heart transplantation (60 days vs. 89 days)
and significantly higher survival rates to transplantation (100% vs. 70%). At
the time of analysis, four of the 30 Total Artificial Heart patients for whom
physical rehabilitation data was available were still on device support, while
88% (23/26) of the remaining Total Artificial Heart patients had been
transplanted..

About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the worlds
first and only FDA, Health Canada
and CE approved Total Artificial Heart. Originally used as a permanent
replacement heart, SynCardias Total Artificial Heart is currently approved as
a bridge to transplant for people dying from end-stage biventricular heart
failure. There have been more than 950 implants of the Total Artificial Heart,
accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia’s Total
Artificial Heart replaces both failing heart ventricles and the four heart
valves, eliminating the symptoms and source of end-stage biventricular failure.
Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia
Certified Centers and does not require expensive anti-rejection medication,
which can cause subsequent complications. It is the only device that
provides immediate, safe blood flow of up to 9.5 liters per minute through both
ventricles. This high volume of safe blood flow helps speed the recovery of
vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among Worlds 50 Most Innovative
Companies

In March 2011, Fast
Company magazine ranked SynCardia #20 in its annual list of the worlds 50
Most Innovative Companies for “giving mobility to artificial heart recipients.”
Weighing 13.5 lbs, SynCardias Freedom® portable driver is the worlds first
wearable driver designed to power the Total Artificial Heart both
inside and outside the hospital. The Freedom driver is CE approved for use in
Europe and undergoing an FDA-approved
Investigational Device Exemption (IDE) clinical study in the U.S.

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