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From earlier: Sunshine Heart, Inc.
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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