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FDA Approves Reimbursement Category for C-Pulse
25 / 09 / 2008
Sunshine Heart (ASX: SHC) announces that the US Food and Drug Administration (FDA) has approved Reimbursement Category B for the C-PulseT US clinical trial. C-Pulse is a heart assist therapy for patients suffering from moderate heart failure.
This approval will provide opportunities for reimbursement during the clinical trial and an initial revenue stream for the Company.
With this approval category, the cost of the C-Pulse system will be eligible for US Medicare reimbursement coverage. Sunshine Heart together with its clinical sites and regional offices of the Center of Medicare and Medicaid Services (CMS) will now resolve reimbursement amounts.
Sunshine Heart has retained Quorum Consulting, Inc. of San Francisco as its reimbursement consultant. Quorum has extensive experience in the design and implementation of reimbursement programs for heart assist devices.
Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, said: "Approval of this category provides a clear reimbursement pathway for the C-Pulse system. This is another key milestone for the Company."
The Company expects patient enrollment to begin in the fourth quarter of 2008 at six premier US medical institutions. William Abraham, MD, of The Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as co-lead national principal investigators.
This approval will provide opportunities for reimbursement during the clinical trial and an initial revenue stream for the Company.
With this approval category, the cost of the C-Pulse system will be eligible for US Medicare reimbursement coverage. Sunshine Heart together with its clinical sites and regional offices of the Center of Medicare and Medicaid Services (CMS) will now resolve reimbursement amounts.
Sunshine Heart has retained Quorum Consulting, Inc. of San Francisco as its reimbursement consultant. Quorum has extensive experience in the design and implementation of reimbursement programs for heart assist devices.
Donald Rohrbaugh, Chief Executive Officer of Sunshine Heart, said: "Approval of this category provides a clear reimbursement pathway for the C-Pulse system. This is another key milestone for the Company."
The Company expects patient enrollment to begin in the fourth quarter of 2008 at six premier US medical institutions. William Abraham, MD, of The Ohio State University, and Patrick McCarthy, MD, of Northwestern University Medical Center, will serve as co-lead national principal investigators.