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"

Tucson, AZ, (PresseBox) - 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.

SynCardia Systems Inc

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.

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 over 1,000 implants of the Total Artificial Heart, accounting for more than 270 patient years of life. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle.

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.

For additional information, please visit:

Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

Press releases you might also be interested in

Subscribe for news

The subscribtion service of the PresseBox informs you about press information of a certain topic by your choice at a choosen time. Please enter your email address to receive the email with the press releases.

An error occurred!

Thank you! You will receive a confirmation email within a few minutes.

I want to subscribe to the gratis press mail and have read and accepted the conditions.