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SynCardia Total Artificial Heart Replaces Left Ventricular Assist Devices in 7 Patients
With Total Artificial Heart, 2 Patients Bridged to Transplant, 5 Currently Waiting for a Matching Donor Heart
(PresseBox) (Tucson, AZ, USA, )
SynCardia Systems, Inc. (http://www.syncardia.com), manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the SynCardia temporary Total Artificial Heart has recently replaced left ventricular assist devices (LVADs) in seven patients suffering from end-stage heart failure.
An LVAD is a continuous-flow, mechanical pump that is implanted adjacent to the heart to assist or take over the pumping function of the left heart ventricle. However, professional papers have documented that right ventricular dysfunction/failure is revealed or develops in 10-30% of patients who receive an LVAD.
"Heart failure is a chronic and progressive disease that usually affects the left ventricle first," said Michael Garippa, SynCardia Chairman/CEO/President. "At the time these patients received an LVAD, it was an effective treatment option. However, their heart failure progressed to where left-side support was no longer enough. The Total Artificial Heart was implanted as the optimal therapy to provide the biventricular support these patients needed to survive. This is a testament to the Total Artificial Heart becoming the new standard of care for end-stage biventricular failure."
In February 2012, a 26-year-old German man who had previously been supported with an LVAD received his matching donor heart after 646 days (1 year, 9 months) of life with the Total Artificial Heart. The same month, a 57-year-old woman in Virginia received her heart transplant after 103 days of support. The other five LVAD patients received the Total Artificial Heart between March and May 2012 and are currently waiting for a matching donor heart.
"For patients with left ventricular failure, LVADs help improve quality of life," said Garippa. "However, while LVADs may slow the progression of heart failure, they do not stop it. SynCardia's Total Artificial Heart is the only device that eliminates the symptoms and source of end-stage biventricular heart failure."
Five of the former LVAD patients received the Total Artificial Heart in the United States, and the other two in Germany and Greece. Currently, there are more than 50 Total Artificial Heart patients awaiting transplant at 29 SynCardia Certified Centers worldwide.
An LVAD is a continuous-flow, mechanical pump that is implanted adjacent to the heart to assist or take over the pumping function of the left heart ventricle. However, professional papers have documented that right ventricular dysfunction/failure is revealed or develops in 10-30% of patients who receive an LVAD.
"Heart failure is a chronic and progressive disease that usually affects the left ventricle first," said Michael Garippa, SynCardia Chairman/CEO/President. "At the time these patients received an LVAD, it was an effective treatment option. However, their heart failure progressed to where left-side support was no longer enough. The Total Artificial Heart was implanted as the optimal therapy to provide the biventricular support these patients needed to survive. This is a testament to the Total Artificial Heart becoming the new standard of care for end-stage biventricular failure."
In February 2012, a 26-year-old German man who had previously been supported with an LVAD received his matching donor heart after 646 days (1 year, 9 months) of life with the Total Artificial Heart. The same month, a 57-year-old woman in Virginia received her heart transplant after 103 days of support. The other five LVAD patients received the Total Artificial Heart between March and May 2012 and are currently waiting for a matching donor heart.
"For patients with left ventricular failure, LVADs help improve quality of life," said Garippa. "However, while LVADs may slow the progression of heart failure, they do not stop it. SynCardia's Total Artificial Heart is the only device that eliminates the symptoms and source of end-stage biventricular heart failure."
Five of the former LVAD patients received the Total Artificial Heart in the United States, and the other two in Germany and Greece. Currently, there are more than 50 Total Artificial Heart patients awaiting transplant at 29 SynCardia Certified Centers worldwide.
Über SynCardia Systems Inc
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE approved Total Artificial Heart. Similar to a heart transplant, the SynCardia temporary 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.
Originally used as a permanent replacement heart, SynCardia’s 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 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles.
SynCardia Ranked #20 Among World’s 50 Most Innovative Companies:
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the world’s 50 Most Innovative Companies for “giving mobility to artificial heart recipients.” Weighing 13.5 lbs, SynCardia’s Freedom® portable driver is the world’s first wearable driver designed to power the Total Artificial Heart both in side 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.
For additional information, please visit: http://www.syncardia.com
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