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

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

SynCardia, artificial heart, Total Artificial Heart, Freedom driver, San Raffaele Hospital, heart failure, donor heart, heart transplant

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.

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.


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. 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 1,000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life.

Similar to a heart transplant, SynCardia's 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. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Wins Two Gold Stevies® at 2012 American Business Awards

On June 18, 2012, SynCardia was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won "Company of the Year – Health Products and Services" and "Most Innovative Company of the Year – up to 100 Employees." See the full list of SynCardia Awards & Recognition, which includes accolades from Forbes, Fast Company and more.

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Don Isaacs
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