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SynCardia Systems, Inc.

Press Release:

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

Thought Leaders Present Cases with Etiologies That Lead to End-Stage Biventricular Heart Failure, Including Cardiac Tumor, Transplant Rejection, Ventricular Septal Defect and Chagas Disease.

SynCardia’s Total Artificial Heart, often powered by the wearable Freedom® portable driver, has been used to eliminate the symptoms and source of end-stage biventricular heart failure brought on by many causes, including cardiac tumor and VAD failure. Top heart surgeons shared their cases in a recent SynCardia Systems, Inc. conference. SynCardia’s Total Artificial Heart, often powered by the wearable Freedom® portable driver, has been used to eliminate the symptoms and source of end-stage biventricular heart failure brought on by many causes, including cardiac tumor and VAD failure. Top heart surgeons shared their cases in a recent SynCardia Systems, Inc. conference. TUCSON, Ariz. – March 25, 2014 – 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.

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
 

“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.

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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 SynCardia 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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