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Final Medicare Decision Provides Maximum Reimbursement to Hospitals for CardioWest temporary Total Artificial Heart: CMS Reverses 1986 National

TUCSON, Ariz. (Business Wire EON) May 6, 2008 -- "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 through the highest paying Diagnostic Related Group (ms-DRG 1 & 2) codes for the artificial heart. 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."

The CardioWest artificial heart is the first and only FDA, Health Canada and CE Mark approved temporary Total Artificial Heart in the world. Originally designed as a permanent replacement heart, it is currently approved as a bridge to human heart transplant for patients dying from end stage biventricular failure.

In the 10-year pivotal clinical study of the CardioWest artificial heart (New England Journal of Medicine 2004; 351: 859-867), 79 percent of patients receiving the artificial heart survived to transplant. This is the highest bridge-to-transplant rate for any heart device in the world. There have been more than 715 implants of the CardioWest, accounting for more than 125 patient years of life on the artificial heart.

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