Press Release:

TUCSON, Ariz. – Feb. 4, 2008 – On February 1, the Centers for Medicare & Medicaid Services (CMS) announced that after completing a review of its 1986 national non-coverage policy for artificial hearts, its preliminary decision is to provide reimbursement for patients who receive the CardioWest™ temporary Total Artificial Heart (TAH-t) as part of FDA studies that meet CMS specifications. Following a public comment period, CMS will post its final decision on May 1, 2008.

“Our proposal relaxes a long-standing non-coverage policy, gives access to our beneficiaries and promotes evidence development through FDA approved studies of this advanced technology,” said CMS Acting Administrator Kerry Weems. “This device may be able to help patients that otherwise have no treatment options available to them.”

“This decision is a historic step toward making the artificial heart available to most Americans,” explained Rodger Ford, president and CEO of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart. “Many smaller insurers use CMS reimbursement decisions as their benchmark for coverage.”

The CardioWest artificial heart is currently covered by about half of insurers, including Aetna and BlueCross BlueShield. With final CMS approval, most insurers are likely to cover the CardioWest artificial heart.

On Aug. 1, 2007, CMS posted a notice to its web site announcing the review of this non-coverage policy, after SynCardia submitted a formal request for coverage of the CardioWest artificial heart when used in accordance with its FDA-approved labeling as a bridge to human heart transplant.

The CardioWest artificial heart received FDA approval on Oct. 15, 2004. It is the world’s only FDA, CE and Health Canada approved temporary total artificial heart. It has been implanted in more than 700 patients, accounting for more than 120 patient years of life on the device.

###

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 250 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 and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. 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.

For additional information, please visit: http://www.syncardia.com
Like SynCardia on Facebook
Follow SynCardia on Twitter – @SynCardia
Connect with SynCardia on LinkedIn

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