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Press Release:

SynCardia's Companion 2 Driver Named a Finalist
in the Medical Design Excellence Awards

In-Hospital Power Supply for the SynCardia Total Artificial Heart Supports Patients
Until They Are Stable and Switched to the Freedom® Portable Driver

 

The Companion 2 Driver (left) is FDA-approved to power the SynCardia Total Artificial Heart in the hospital and on hospital grounds. It weighs 80% less than “Big Blue,” the original FDA-approved hospital driver.The Companion 2 Driver (left) is FDA-approved to power the SynCardia Total Artificial Heart in the hospital and on hospital grounds. It weighs 80% less than “Big Blue,” the original FDA-approved hospital driver.

TUCSON, Ariz. – April 4, 2013 – SynCardia Systems, Inc., the privately-held manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that its Companion 2 (C2) Driver System, which powers the SynCardia temporary Total Artificial Heart in the hospital, has been selected as one of four finalists in the Critical-Care and Emergency Medicine Products category of the 15th Annual Medical Design Excellence Awards (MDEA). The winners will be announced on June 19 in Philadelphia.

“Prior to the development of the C2 Driver, the only FDA-approved driver for powering the Total Artificial Heart in the hospital was the 418-pound ‘Big Blue’ driver,” said Michael Garippa, SynCardia Chairman/CEO/President. “Although Big Blue is extremely reliable, its size and weight reduces patient mobility and there are only 36 available worldwide. The state-of-the-art C2 Driver, which we manufacture and have more than 90 units at SynCardia Certified Centers, is both robust and mobile, supporting very sick patients of all sizes in the operating room and in the hospital during recovery and ambulation.”

For the Total Artificial Heart implant, the C2 Driver is docked in the Hospital Cart. Featuring sturdy support handles and locking casters, the Hospital Cart assists patients in standing and walking during their early recovery. Once the patient is out of bed and ambulatory, the C2 Driver can be docked in the Driver Caddy, which provides patients with
greater mobility in the hospital and on hospital grounds.

Once stable, patients who are eligible can be switched to the 13.5-pound Freedom® portable driver, the world’s first wearable power supply for the SynCardia Total Artificial Heart. Patients who meet discharge criteria can then leave the hospital and wait for a matching donor heart at home and in their communities. The Freedom portable driver was selected by MDEA as the Bronze Winner in the Critical Care and Emergency Medicine Products category in 2012.

The Medical Design Excellence Awards are the industry’s premier design awards competition and is the only awards program exclusively recognizing contributions and advances in the design of medical products. Entries were evaluated on the basis of their design and engineering features, including innovative use of materials, user-related functions that improve healthcare delivery and change traditional medical attitudes or practices, features that provide enhanced benefits to the patient, and the ability to overcome design and engineering challenges to meet clinical objectives.

CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

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SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and 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 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.

The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 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 September 11, 2011.

SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by more than 190 patients, accounting for over 110 years of support

 

Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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