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SynCardia Systems, Inc.

Press Release:

1st U.S. Patient Discharged from the Hospital without a Human Heart Celebrates 5th Anniversary of Going Home with the Freedom® Portable Driver

More than 220 clinically stable SynCardia Total Artificial Heart patients have received the Freedom® portable driver for over 140 patient years of support. Over 150 of these patients were discharged to recover and exercise while waiting for donor hearts.

Nearly five years ago Charles Okeke, holding hands with his wife, Natalie, walked out of an Arizona heart center as the first U.S. patient without a human heart to be discharged from a hospital. He was supported by the SynCardia Total Artificial Heart powered by the Freedom® portable driver until he received his dual heart and kidney transplant on January 15, 2011. Nearly five years ago Charles Okeke, holding hands with his wife, Natalie, walked out of an Arizona heart center as the first U.S. patient without a human heart to be discharged from a hospital. He was supported by the SynCardia Total Artificial Heart powered by the Freedom® portable driver until he received his dual heart and kidney transplant on January 15, 2011. TUCSON, Ariz. – Apr. 23, 2015 – Nearly five years ago, on May 3, 2010, Charles Okeke became the first United States patient to be discharged from the hospital without a human heart when he walked out of an Arizona heart center.

Since 2010, the SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver has supported more than 220 clinically stable patients. Over 150 patients have been discharged to recover and exercise at home and in their communities as they waited for donor hearts.

“Some patients aren’t discharged for a variety of reasons,” says Michael Garippa, CEO and President of SynCardia Systems Inc. “Some don’t have the caregiver support they need or they live more than two hours travel time from the heart center that will do their transplants. Some get a heart transplant before they have a chance to go home.”

Discharge allows Freedom® portable driver patients to get in better shape for their heart transplants while getting back to their lives. Two patients who are waiting for their matching donor hearts are getting close to four years of support on the SynCardia Total Artificial Heart powered by the Freedom® portable driver.

“Patients get to sleep in their own beds, socialize with their friends, go out to dinner, attend religious services and live a pretty normal life,” says Garippa. “Some even go on vacation, four-wheeling and do practically anything they would do with a human heart.”

Phoenix, Arizona resident Charles Okeke received the SynCardia Total Artificial Heart as a bridge to transplant on September 8, 2008, when his body was rejecting an earlier heart transplant.

For 600 days, Okeke was confined to the hospital tethered to a 418-pound hospital driver that powered his SynCardia Heart. Like a heart transplant, the SynCardia Total Artificial Heart is the only approved device that eliminates the source of end-stage biventricular (both sides) heart failure.

In March 2010, the FDA approved a clinical study into the effectiveness of the Freedom® portable driver, a 13.5-pound unit that powers the SynCardia Total Artificial Heart and that gives clinically stable patients nearly unlimited mobility.

Okeke now had the opportunity to receive the Freedom® portable driver and be discharged home. But he had concerns.

“How have the human clinical trials been (going)?” he recalls saying before he was given the Freedom® portable driver, “and realizing from the stares, you ARE the (first patient that is part of the)…clinical trial."

Okeke remembers feeling free when he walked out of the hospital without a human heart. “You don't really know how much you miss fresh air, sun(shine) until it's been taken away from you for a long time,” he says.

He spent eight months at home with his family until he received a donor heart-kidney transplant January 15, 2011.

Okeke made his comments during a recent visit to SynCardia Systems, Inc. with his wife and three children to mark the fifth anniversary of his hospital discharge. He said he felt fine and grateful. “All the time I'm taking stock of how blessed I am, how great a family that I do have,” he says.

Worldwide the Freedom® portable driver has
  • been used by 221 patients
  • allowed 153 clinically stable patients to be discharged from the hospital
  • provided 143 patient years of support.

The FDA on June 26, 2014 approved the use of the Freedom® portable driver for all clinically stable U.S. patients on the SynCardia Total Artificial Heart. The Freedom® portable driver also is approved by Health Canada and has the CE Mark for use in Europe.

SynCardia is conducting an FDA-approved clinical study on the effectiveness of the SynCardia Total Artificial Heart and the Freedom® portable driver for use as destination therapy, also known as permanent use, in the United States. (CAUTION - The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.)

 

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About the SynCardia temporary Total Artificial Heart

SynCardia Systems, Inc. in Tucson, Arizona is the manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart for use as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.

More than 1,440 implants of the SynCardia Total Artificial Heart account for over 465 patient years of life on the device. Since January 2010 more than 600 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 80 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to be discharged from the hospital to live at home and in their communities. The Freedom® portable driver has been used by more than 220 patients, accounting for over 140 years of patient support.

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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