Sunshine Heart Provides Update on U.S. Pivotal Study of C-Pulse(R) Heart Assist System
April 16 2015 - 4:53PM
Sunshine Heart, Inc. (Nasdaq:SSH) announced today that the U.S.
Food and Drug Administration (FDA) has reviewed the Company's
submission regarding the COUNTER HF's U.S. pivotal study pause and
requested minor protocol changes be submitted in order to receive
approval to resume patient enrollment. The FDA did not indicate
concerns regarding safety of the device and requested the updated
protocol include information on several minor items, the most
significant of which are the details regarding the Company's
proposal to incorporate a Physician Subject Selection Committee.
Furthermore, the Data Safety Monitoring Board (DSMB), reviewed
COUNTER HF's data and recommended continuing the Study.
"We are pleased the FDA has offered a collaborative process to
enable the Study to commence in a timely manner. We were prepared
for these types of minor protocol modifications and as such, we'll
be submitting these amendments by early next week," commented Dave
Rosa, President and Chief Executive Officer of Sunshine Heart.
Sunshine Heart previously announced on March 6, 2015, a
temporary pause from enrollment in accordance with the study
protocol. The protocol indicated that in the event more than three
of the first twenty subjects pass away for any reason, including
non-device related deaths, the Company would work with the FDA to
establish a plan before resuming enrollment. All four of the
reported patient deaths have been adjudicated by an independent
Clinical Events Committee (CEC) as being non-device related.
COUNTER HF is a prospective, randomized, multi-center,
controlled study evaluating the safety and efficacy of the C-Pulse
system for the treatment of NYHA Class III and ambulatory Class IV
heart failure. The Study is being conducted by heart failure,
electrophysiologists and cardiac surgeon specialists in the United
States. It is expected to randomize 388 patients in up to 40
clinical sites. The purpose of the study is to determine whether
the C-Pulse System is a safe and effective treatment for heart
failure patients who meet the following key study
qualifications:
- NYHA Class III or early Class IV heart failure*;
- Ejection fraction ≤ 35% (measure of how well the heart pumps
blood);
- Taking appropriate heart failure medications as prescribed by
doctor; and
- Have been evaluated for cardiac resynchronization therapy with
or without defibrillation (CRT, CRT-D) or implantable cardioverter
defibrillator (ICD) therapy.
*New York Heart Class (NYHA) Class III or early Class IV: Very
limited in daily activities or unable to do activities without
discomfort. Become tired, short of breath, and have heart
palpitations during physical activity. Note: Other qualifications
apply and study doctors will determine who is eligible for the
study.
About the C-Pulse® Heart Assist System
The C-Pulse Heart Assist System, or C-Pulse System, an
investigational device in the United
States, Canada and countries that do not recognize the CE
mark approval, utilizes the scientific principles of intra-aortic
balloon counter-pulsation applied in an extra-aortic approach to
assist the left ventricle by reducing the workload required to pump
blood throughout the body, while increasing blood flow to the
coronary arteries. Combined, these potential benefits may help
sustain the patient's current condition or, in some cases, reverse
the heart failure process, thereby potentially preventing the need
for later-stage heart failure devices, such as left ventricular
assist devices (LVADs), artificial hearts or transplants. It may
also provide relief from the symptoms of Class III and ambulatory
Class IV heart failure and improve quality of life and cardiac
function. Based on the results from our feasibility study, we also
believe that some patients treated with our C-Pulse System may be
able to stop using the device due to sustained improvement in their
conditions as a result of the therapy.
Caution: Investigational device, limited by Federal
(or United States) Law to Investigational use. About
Sunshine® Heart
Sunshine Heart, Inc. (Nasdaq:SSH) is an early-stage medical
device company focused on developing, manufacturing and
commercializing the C-Pulse System for treatment of Class III and
ambulatory Class IV heart failure. Sunshine Heart has
completed an approved U.S. Food and Drug Administration (FDA)
feasibility clinical study of the C-Pulse System and presented the
results in November 2011. In March 2012,
the FDA notified the Company that it could move forward
with an investigational device exemption (IDE)
application. Sunshine Heart received unconditional
approval from the FDA in November 2012 to initiate
its pivotal study. In July 2012, Sunshine
Heart received CE Mark approval for its C-Pulse System
in Europe. Sunshine Heart is a
Delaware corporation headquartered
in Minneapolis with wholly owned subsidiaries
in Australia and Ireland. The Company has been
listed on the NASDAQ Capital Market since February
2012.
Forward-Looking Statements
Certain statements in this release are forward-looking
statements that are based on management's beliefs, assumptions,
expectations, and information currently available to management.
All statements that address future operating performance, events or
developments that we expect or anticipate will occur in the future
are forward-looking statements, including, without limitation, our
expectations with respect to future clinical study activities and
results including patient enrollment in studies. These
forward-looking statements are subject to numerous risks and
uncertainties, including, without limitation, the possibility that
our clinical studies do not meet their enrollment goals, meet their
endpoints or otherwise fail, that regulatory authorities do not
accept our application or approve the marketing of the C-Pulse
System, the possibility that we may be unable to raise the funds
necessary for the development and commercialization of our
products, that we may not be able to commercialize our products
successfully in the EU and the other risk factors described under
the caption "Risk Factors" and elsewhere in our filings with
the U.S. Securities and Exchange Commission. You should not
place undue reliance on forward-looking statements because they
speak only as of the date when made and may turn out to be
inaccurate. We do not assume any obligation to publicly update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise. We may not actually
achieve the plans, projections or expectations disclosed in
forward-looking statements, and actual results, developments or
events could differ materially from those disclosed in the
forward-looking statements.
CONTACT: Investor:
Candice Knoll
Blueprint Life Science Group
T: +1-415-375-3340 Ext. 105
Claudia Drayton
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4200
Media:
David Schull
Russo Partners
T: +1-212-845-4271
Christopher Hippolyte
Russo Partners
T: + 1-646-942-5634
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