Top U.S. Heart Surgeons Share Best Practices for Using the SynCardia Total Artificial Heart


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[IN] MEQ HEA MTC

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-- WITH PHOTO -- TO BUSINESS, HEALTH, AND MEDICAL EDITORS:

Top U.S. Heart Surgeons Share Best Practices for Using the SynCardia

Total Artificial Heart

TUCSON, Ariz., March 25, 2014 /PRNewswire/ -- Thought leaders in the

U.S. heart transplant and mechanical device field recently detailed

the best practices for a growing list of uses for the SynCardia

temporary Total Artificial Heart, demonstrating how the world's first

and only FDA, Health Canada and CE approved Total Artificial Heart can

give very sick patients with end-stage biventricular heart failure

second chances at life.

Listen to the 35-minute SynCardia Users Best Practices Conference

These talented heart surgeons shared cases that illustrate the use of

the SynCardia Total Artificial Heart as a bridge to donor heart

transplant for patients whose complex medical conditions require the

SynCardia Heart for survival.

-- Dr. Francisco Arabia, Cedars-Sinai Medical Center

-- Dr. Brian Bruckner, Houston Methodist Hospital's DeBakey Heart

Center

-- Dr. Jack G. Copeland, University of California, San Diego

-- Dr. Igor Gregoric, Memorial Hermann - Texas Medical Center

-- Dr. Vigneshwar Kasirajan, Virginia Commonwealth University Medical

Center

-- Dr. Angela Lorts, Cincinnati Children's Hospital Medical Center

In a conference call with physicians from SynCardia Certified Centers,

the physicians discussed interesting cases treating patients with the

SynCardia Total Artificial Heart.

"Our job is to try and promote the education of these unusual

(etiologies) because they are happening more and more often

worldwide," said Michael P. Garippa, SynCardia CEO and President.

"Future calls will address amyloidosis, myocarditis and many others."

Cardiac Tumor

Bruckner and Gregoric spoke about two cases of patients with cardiac

sarcoma. In each case, the cancerous, failing heart was removed and a

SynCardia Heart implanted.

"I think the use of the SynCardia Total Artificial Heart can be a

viable alternative, especially to young patients who have isolated

cardiac tumor," said Bruckner, "and may become transplant candidates.

"It's a viable option for patients who have no other options."

Transplant Rejection & Recovery of Kidney Function

Lorts detailed the case of a 19-year-old woman who suffered both

failure of one remaining kidney and rejection of a donor heart. She

was implanted with the SynCardia Total Artificial Heart in Nov. 2012.

For almost two months after the implant surgery, she continued to

produce no urine, so she was scheduled for surgery on Jan. 2, 2013 to

receive a permanent catheter. However, on Jan. 1, she began making

urine. She was transplanted with a second donor heart last December.

Ventricular Septal Defect (VSD)

Gregoric detailed his case of a 63-year-old male who had a heart

attack resulting in a large VSD followed by cardiogenic shock. The

patient was placed on a cardiac assist device, but when doctors could

not close the growing defect, they replaced the device and his failing

heart with a SynCardia Heart.

Ventricular Assist Device (VAD) Failure

Arabia and Kasirajan discussed the use of the SynCardia Heart because

of infection and thrombosis that sometimes occur after a VAD implant.

They noted that in some VAD failure patients dealing with arrhythmias,

or rapid heartbeat, SynCardia Heart implants could be a better choice

because of the difficulty in controlling the condition.

Best Practices

Copeland led a discussion on strategies surgeons can use to fit a 70cc

SynCardia Heart into a smaller patient who may be outside the 1.7 BSA

(Body Surface Area) measurement. Lorts told of her experience using 3D

software that allows surgeons to virtually implant the SynCardia Heart

before the actual operation.

Doctors at Cincinnati Children's have used the software for fit

studies to determine which pediatric patients might be able to receive

a 70cc SynCardia Heart implant. "It's really helpful for the

congenital kids because you can reconstruct and see where everything

is going to fit," said Lorts. The software is planned to be used

following the FDA-approved 50cc SynCardia Total Artificial Heart

study.

SynCardia plans to launch clinical trials this summer using the

smaller 50cc SynCardia Total Artificial Heart designed for people of

smaller stature. Once approved by the FDA, it and the 70cc size will

allow all adults and many adolescents to be eligible for a SynCardia

Heart implant.

More than 400 SynCardia Total Artificial Heart implants have been

performed since January 2011. The SynCardia Heart has provided almost

130,000 patient days of support in nearly 1,300 implants. The youngest

patient to receive a SynCardia Heart was 9 years old; the oldest was

76 years old.

-- Read one patient's experience with reversal of renal failure with

the SynCardia Total Artificial Heart.

-- Watch a video presentation on reversing organ failure with the

SynCardia Total Artificial Heart.

-- Read about a case report on a virtual 3D modeling platform that

helps surgeons fit the SynCardia Heart.

CAUTION - The Freedom portable driver is an investigational device,

limited by United States law to investigational use.

About the SynCardia temporary Total Artificial Heart

For additional information, please visit: http://www.syncardia.com/

Like SynCardia on Facebook Follow SynCardia on Twitter - @SynCardia

Connect with SynCardia on LinkedIn

Photo - http://photos.prnewswire.com/prnh/20140325/LA90682

SOURCE SynCardia Systems, Inc.

-0- 03/25/2014

/CONTACT: Don Isaacs, Vice President of Communications, SynCardia Systems, Inc., Cell: (520) 955-0660

/Photo: http://photos.prnewswire.com/prnh/20140325/LA90682

PRN Photo Desk, photodesk@prnewswire.com

/Web Site: http://www.syncardia.com

CO: SynCardia Systems, Inc.

ST: Arizona

IN: MEQ HEA MTC

SU: SVY

PRN

-- LA90682 --

0000 03/25/2014 21:00:00 EDT http://www.prnewswire.com

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