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SynCardia Systems, Inc.

Press Release:

VCU Medical Center Performs 900th Implant Worldwide of SynCardia’s Total Artificial Heart

SynCardia Certified Center Achieved 100% Survival Rate with 21 Total Artificial Heart Patients in 2010

Dr. Vigneshwar Kasirajan, chair of cardiothoracic surgery and director of the heart transplantation program at Virginia Commonwealth University Medical Center Dr. Vigneshwar Kasirajan, chair of cardiothoracic surgery and director of the heart transplantation program at Virginia Commonwealth University Medical Center TUCSON, Ariz. – Jan. 11, 2011 – On Dec. 28, 2010, Virginia Commonwealth University Medical Center (VCU) performed the 900th implant worldwide of the SynCardia temporary Total Artificial Heart.

"Since becoming a SynCardia Certified Center in 2006, we have performed a total of 49 implants of the Total Artificial Heart," said Dr. Vigneshwar Kasirajan, chair of cardiothoracic surgery and director of the heart transplantation program at VCU. "In our experience, although Total Artificial Heart patients with both sides of the heart failing are sicker than ventricular assist device patients, we consistently achieve excellent patient outcomes with the Total Artificial Heart."

VCU Medical Center achieved a 100% survival rate with the Total Artificial Heart in 2010 for the 21 patients implanted at the Richmond hospital. Of these patients, 13 were bridged to a heart transplant and 8 are currently awaiting a matching donor heart on the Total.  

Since performing the first implant of the Total Artificial Heart on the East Coast in 2006, VCU has achieved one of the best success rates in the country, an approximate 85 percent survival rate among its Total Artificial Heart patients.

VCU is one of up to 30 centers participating in the FDA-approved Investigational Device Exemption (IDE) clinical study of the new Freedom® driver, the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. The IDE clinical study is designed to demonstrate that the Freedom driver is a suitable pneumatic driver for stable Total Artificial Heart patients and can be safely used at home. Dr. Kasirajan, principal investigator for the clinical trial, is a consultant and proctor surgeon for SynCardia.

"This is the kind of technology that changes lives," said John Duval, CEO of MCV Hospitals at VCU Medical Center. "The Freedom portable driver will allow many stable Total Artificial Heart patients to recuperate in the comfort of their own homes with their families while they wait for a matching donor heart. Prior to the advent of this portable driver, patients were confined to the hospital for months and sometimes more than a year while waiting for a heart transplant."

The Freedom driver has been CE approved for commercial use in Europe and is currently undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S. CAUTION – The Freedom driver is an investigational device, limited by United States law to investigational use.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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