SOURCE: SynCardia Systems, Inc.

SynCardia Systems, Inc.

April 21, 2011 09:00 ET

After 832 Days, San Camillo Hospital Transplants 1st Total Artificial Heart Patient

40-Year-Old Father Enjoyed 2 Years of Life at Home and in His Community While Waiting for Donor Heart Using Portable Driver

TUCSON, AZ--(Marketwire - Apr 21, 2011) - On April 2, San Camillo Hospital in Rome discharged its first patient to be bridged to transplant with SynCardia's Total Artificial Heart. On Feb. 23, after 832 days of life with the Total Artificial Heart, Giuseppe Nicotera received the heart transplant he'd been waiting more than two years for.

"For our first patient, SynCardia's Total Artificial Heart proved to be an effective mechanical support treatment," said Prof. Francesco Musumeci, Director of Cardiac Surgery and Heart Transplantation. "The device rapidly stabilized the patient's hemodynamics and provided full recovery of end-organ function. We consider the Total Artificial Heart a safe option to offer to our patients in cases of severe biventricular heart failure."

Mr. Nicotera, a 40-year-old hospital laboratory technician and married father of one, was admitted to San Camillo Hospital in October 2008 suffering from severe heart failure. His liver and kidneys began to fail while in the Intensive Care Unit. On Nov. 13, 2008, doctors decided to implant the Total Artificial Heart as the only option to stabilize his condition until a matching donor heart became available.

"After I received the Total Artificial Heart, I felt much better ... as good as I felt before I developed my severe illness," said Mr. Nicotera. "When I was told I would be able to go home using the portable driver, I was surprised and very happy. I rejoined my family and my friends. I enjoyed a normal life!"

Once stable, Mr. Nicotera was switched from the large hospital implant driver to a small portable driver which is CE approved for use in Europe. About a month later, he was discharged from the hospital to wait for his transplant at home with his family.

"The Total Artificial Heart proved to be effective for patient care outside the hospital," said cardiothoracic surgeon Dr. Antonio Loforte. "It provided, in our opinion, a much improved quality of life for this patient until he received his heart transplant."

In Italy, more than 700 patients are waiting for a matching donor heart but only approximately 300 heart transplants are performed each year. The average wait time for a heart transplant is about 2 years and approximately 10% of patients die while waiting.

SynCardia would like to recognize and thank Managing Director Claudio Gibelli and Vega S.p.A., the Italian distributor for the Total Artificial Heart, for their commitment and ongoing support of San Camillo Hospital.

About the SynCardia temporary Total Artificial Heart
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 900 implants of the Total Artificial Heart, accounting for more than 210 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 for powering 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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Contact Information

  • Media Contact:
    Don Isaacs
    Vice President of Communications
    SynCardia Systems, Inc.
    Cell: (520) 955-0660