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SynCardia Systems, Inc.

Press Release:

San Raffaele Hospital in Italy Discharges First SynCardia Total Artificial Heart Patient Home

For Postcardiotomy Cardiogenic Shock Patients on ECMO, "Lack of Recovery within One Week Requires Replacement of the Heart Before Complications Ensue"

 

On Sept. 7, 2012, Marco Fumagalli became the first SynCardia Total Artificial Heart patient to be discharged from San Raffaele Hospital in Milan, Italy, using the Freedom® portable driver. He is pictured with his wife Rosalena Carenzi.

TUCSON, Ariz. – Oct. 18, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that San Raffaele Hospital in Milan, Italy, has discharged its first patient to receive the SynCardia temporary Total Artificial Heart. On Sept. 7, 55-year-old Marco Fumagalli left the hospital to wait for a matching donor heart at home using the Freedom® portable driver to power his Total Artificial Heart.

"The SynCardia Total Artificial Heart is the only option for postcardiotomy cardiogenic shock patients with biventricular failure and a mechanical prosthesis in the mitral position," said Dr. Federico Pappalardo. "We have learned from our extensive experience using ECMO to rescue cardiogenic shock patients that lack of recovery within one week requires replacement of the heart before complications ensue. The Total Artificial Heart should be readily available for patients who meet these indications."

Mr. Fumagalli was admitted to the hospital on March 4, after he suffered a heart attack that ruptured the papillary muscles of his heart. Doctors performed an emergency operation to replace his mitral valve with a mechanical one. However, despite the use of inotropes and an intra-aortic balloon pump, he quickly developed cardiogenic shock, where the heart is so damaged that it is unable to supply enough blood to the organs of the body.

Mr. Fumagalli was placed on extracorporeal membrane oxygenation (ECMO) for five days. ECMO restored blood flow to Mr. Fumagalli’s brain, kidneys and liver, but his heart, which had severe biventricular failure, did not recover. On March 9, Dr. Michele De Bonis performed the hospital’s first implant of the SynCardia Total Artificial Heart as the only option to save Mr. Fumagalli’s life and bridge him to a heart transplant.

“When I came back home, everybody looked at me walking in the park and could not believe that I was so fit and healthy after all the stories they had been told about my heart attack and the operation to fully replace my heart,” said Mr. Fumagalli. “They were expecting me to be in a wheelchair, but I was walking with my Freedom driver and looked very confident. I am back to my life and I am able to cook my favorite dishes.”

Weighing approximately 6 kg (13.5 pounds), the Freedom portable driver is the world's first wearable power supply for the SynCardia Total Artificial Heart. 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.

SynCardia recognizes and thanks Managing Director Claudio Gibelli and Vega S.p.A., the Italian distributor for the Total Artificial Heart, for their commitment and on-going support of the five SynCardia Certified Centers in Italy.

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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