First Patients in United States Receive Innovative Device to Treat Moderate Heart...
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First Patients in United States Receive Innovative Device to Treat Moderate
Heart Failure
The Ohio State University Medical Center Implants Two Patients with Sunshine
Heart's C-Pulse(TM) Heart Assist System Under FDA-Approved Clinical Trial
SYDNEY, and TUSTIN, Calif., April 21 /PRNewswire/ -- Sunshine Heart (ASX:
SHC), a global medical device company focused on innovative heart assist
technologies, announced today that The Ohio State University Medical Center in
Columbus, Ohio has successfully completed the first two implants of the
Company's C-Pulse(TM) heart assist system under a 20 person clinical trial
approved by the U.S. Food and Drug Administration (FDA).
These C-Pulse systems were implanted by Dr. Benjamin Sun, Chief, Division of
Cardiothoracic Surgery and Director, Cardiac Transplantation and Mechanical
Support.
"It is an honor to have completed the first U.S. implants of the C-Pulse heart
assist system," said Dr. Sun. "C-Pulse is highly innovative and implanted with
a simple, low-risk minimally invasive surgical procedure. The device has the
potential to offer a new therapy option for the treatment of moderate heart
failure."
"We are excited that our clinical trial in the U.S. has started so
successfully," said Dr. William Peters, Medical Director of Sunshine Heart and
the inventor of C-Pulse. "We have demonstrated in prior clinical studies that
the C-Pulse system increases blood flow to the body and to the heart muscle
itself. We anticipate that C-Pulse will offer patients a significant
improvement in quality of life." Dr. Peters went on to point out importantly
that the device operates without coming into direct contact with the blood, so
avoiding potential complications with systems that do contact blood. A feature
of the design of the C-Pulse is that patients can safely disconnect from the
device for short periods for their convenience."
"The completion of the initial C-Pulse implants in the U.S. is a major
milestone for Sunshine Heart which is the only non-blood contacting heart
assist device in clinical trials," said Don Rohrbaugh, the Company's CEO. "The
start of our clinical trial brings us one step closer toward our goal to
address the large and growing unmet clinical need for an alternative heart
failure treatment to improve and sustain a patient's quality of life." Mr.
Rohrbaugh noted, "C-Pulse is designed for Class III heart failure patients and
these are defined as suffering continuing debilitating symptoms despite
maximum drug therapy."
The 20 patient FDA-approved feasibility clinical trial is being undertaken at
six U.S. medical institutions: Northwestern Memorial Hospital, The Ohio State
Medical Center Jewish Hospital University (University of Louisville), Hershey
Medical Center of the Pennsylvania State University, University of Florida
School of Medicine and University of Alabama/ Birmingham Medical Center.
About Class III Heart Failure
Heart failure is a common condition in which the heart becomes unable to pump
sufficient blood to meet the body's needs. Over five million people in the
United States have heart failure and it results in over 300,000 deaths each
year. Heart failure is a progressive condition and typically results from
damage to the heart muscle arising from a heart attack or virus.
Cardiologists use a classification system to define the four classes of heart
failure; each class is determined by rating a patient's symptoms to everyday
activities and quality of life. Over 1.4 million US heart failure patients are
in the Class III or moderate heart failure category which is defined by the
limitation of physical activity. These patients are comfortable at rest, but
levels of activity regarded as less than ordinary cause fatigue, palpitation,
and/or shortness of breath. The most common treatments for Class III heart
failure are drugs, lifestyle adjustments, family education, device therapy
(i.e. heart failure pacemaker with or without a defibrillator), or surgery. A
major medical treatment challenge is that the medical regimen and CRT options
often stop alleviating symptoms over time, hence the need for C-Pulse heart
assist.
About Sunshine Heart
Sunshine Heart (ASX: SHC) (www.sunshineheart.com) is a global medical device
company, committed to the commercialization of C-Pulse(TM) an implantable,
non-blood contacting, heart assist therapy for the treatment of people with
moderate heart failure. C-Pulse reduces the symptoms of heart failure through
the use of counterpulsation technology which enables an increase in cardiac
output, an increase in coronary blood flow and reduction in the heart's
pumping workload. The Company has received approval from the U.S. Food and
Drug Administration (FDA) to conduct a 20 person U.S. feasibility clinical
trial with C-Pulse and patient enrolment and implants have commenced.
Sunshine Heart listed on the ASX in September 2004 has a presence in
Australia, New Zealand and the United States of America.
For further information, please visit www.sunshineheart.com or contact:
Don Rohrbaugh
Chief Executive Officer
+1 714 259 0732
don.rohrbaugh@sunshineheart.com
Investors/Media:
The Ruth Group
R.J. Pellegrino/Scott Lerman
646-536-7009/7013
rpellegrino@theruthgroup.com
slerman@theruthgroup.com
This press release may contain forward-looking statements that are based on
current management expectations. These statements may differ materially from
actual future events or results due to certain risks and uncertainties from
time to time in the Company's filings with the Australian Securities Exchange.
SOURCE Sunshine Heart
Don Rohrbaugh, Chief Executive Officer, +1-714-259-0732,
don.rohrbaugh@sunshineheart.com; or Investors/Media: R.J. Pellegrino,
+1-646-536-7009, rpellegrino@theruthgroup.com, or Scott Lerman,
+1-646-536-7013, slerman@theruthgroup.com, both of The Ruth Group
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