Press Release:

Rodger Ford, President and CEO, SynCardia Systems, Inc.

TUCSON, Ariz. – May 6, 2008 – On May 1, the Centers for Medicare and Medicaid Services (CMS) issued its final National Coverage Decision (NCD) to reimburse the CardioWest™ temporary Total Artificial Heart (TAH-t) as part of FDA studies that meet CMS specifications.

“Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology,” said CMS Acting Administrator Kerry Weems. “Our decision also encourages the completion of FDA post-approval studies.”

“This final decision makes the CardioWest artificial heart available to nearly all insured Americans, because most smaller insurers use CMS decisions as their benchmark for coverage,” said Rodger Ford, President and CEO of SynCardia Systems, Inc. Prior to this decision, approximately half of all insurers covered the CardioWest, including Aetna, Cigna and BlueCross BlueShield.

Effective May 1, 2008, Medicare patients who are dying from end-stage biventricular failure are eligible to receive the artificial heart as a bridge to human heart transplant. These patients are days, if not hours from death. Their survival is dependent on receiving an immediate matching donor heart or a CardioWest as a bridge-to-transplant.

In a CMS document published April 14, 2008, CMS proposed reimbursement for the CardioWest artificial heart through the highest paying Diagnostic Related Group codes, ms-DRG 1 & 2. In addition, centers implanting the CardioWest artificial heart may qualify for new technology add-on allowance payments. These proposals will become final following a 60-day public comment period on August 1.

“With this decision, CardioWest certified centers will be eligible to receive CMS reimbursement as a part of our FDA Post-Approval Study,” said Cary Marcot, SynCardia Vice President of Regulatory Affairs and Quality.

Later this year, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the new Companion Drive System, which is designed for use both in the hospital and for discharge. Joining the 11 current U.S. CardioWest certified hospitals are eleven additional U.S. hospitals that are in the process of gaining CardioWest certification so they can be part of this study. 

“CMS approval and the IDE clinical study of our discharge driver will finally allow hospitals to be adequately reimbursed for the life-saving services they provide,” said Ford. “When a stable CardioWest patient is discharged through the IDE study and then returns for a donor heart transplant, the hospital will be eligible to receive maximum reimbursement for both the implantation of the artificial heart and for the heart transplant procedure.”

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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 950 implants of the Total Artificial Heart, accounting for more than 230 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
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660