SynCardia Total Artificial Heart Receives FDA Humanitarian Use Device Designation for Destination Therapy

SynCardia Total Artificial Heart Receives FDA Humanitarian Use Device Designation for Destination Therapy

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 AwardsSM

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.

SynCardia Systems has received a Humanitarian Use Device (HUD) designation for its total artificial heart to be used for destination therapy. While the system was already FDA approved for bridging the period to transplant, the designation means it can now also be used in end-stage heart failure patients not eligible for cardiac transplantation as a permanent solution for the rest of their lives. According to the company this group comprises up to 4,000 U.S. patients each year.

SynCardia drivers SynCardia Total Artificial Heart Receives FDA Humanitarian Use Device Designation for Destination TherapyThe SynCardia replaces both ventricles, weighs 160 grams and has a cardiac output of up to 9.5 L/min. The SynCardia artificial heart originally received FDA approval in 2004 as a bridge to transplant and, impressively, has already supported one patient for almost four years prior to transplantation.

Destination therapy has become an option because of the portable Freedom driver, which powers the artificial heart and about which we have reported several times before. The 13.5-pound driver substitutes the old 400-pound driver that kept patients hospital-bound. One hurdle still remains though, before patients can go home with the device, as the Freedom driver itself is still an investigational device currently undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study.

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.

Source : http://www.syncardia.com/2012-Press-Releases/syncardias-total-artificial-heart-receives-hud-designation-for-destination-therapy-from-fda.html

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