Sunshine Heart Received FDA Approval for C-Pulse System's Pivotal Trial
From earlier: Sunshine Heart, Inc. (NASDAQ: SSH) today announced it has received unconditional approval from the FDA to commence its pivotal U.S. trial for its flagship C-Pulse(R) Heart Assist System. "We are pleased to have expeditiously completed the approval process with the FDA. We are excited to evaluate the C-Pulse System's potential in treating patients suffering from Class III and ambulatory Class IV heart failure. We also are eager to evaluate its clinical and economic impact in reducing re-hospitalization rates due to worsening heart failure as this represents the highest and most costly re-hospitalization rates plaguing the U.S. healthcare system today. All of us at Sunshine Heart are committed to expediting this next phase of technology advancement," commented Dave Rosa. Sunshine Heart plans to initiate the pivotal trial in North America in the fourth quarter of 2012. The Company has contacted a number of leading heart failure centers in the U.S. and to date is encouraged by the positive response to participate in the trial. The trial design will consist of 388-patients of which half will be implanted with the C-Pulse System. The other half will be randomized to optimal medical therapy across 30-40 clinical sites. Sunshine Heart expects to receive revenues from trial sites for device implants as the FDA has granted CMS Category B3 status. Because of this designation, it is also anticipated that participating trial centers will be reimbursed by CMS and most private insurance providers. The trial will utilize the Company's next-generation single unit C-Pulse driver, which received approval for clinical trial use from the FDA in August, 2012, and has been in use in Canadian and U.S. patients currently on the device. The new driver features a single unit, which is lighter, quieter, approximately half the size of its predecessor,
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