DGAP-News: Sunshine Heart's C-Pulse Device Reaches Treatment Milestone for Heart Failure
(firmenpresse) - Sunshine Heart, Inc.
18.06.2013 11:15
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25 Patient-Years of Cumulative Utilization Across 25 Patients
EDEN PRAIRIE, Minn., 2013-06-18 11:15 CEST (GLOBE NEWSWIRE) --
Sunshine Heart, Inc. (Nasdaq:SSH) today announced a major milestone for its
flagship C-Pulse device. As of today, C-Pulse has been implanted in 25 patients
in North America and Germany, representing a cumulative 25 years of active
C-Pulse heart failure treatment, or over one billion inflation and deflation
cycles. The 25th patient was implanted on June 14, 2013 at German Heart
Institute - Berlin (DHZB).
Of particular note, throughout decades of treatment, C-Pulse has never recorded
a neurologic event associated with the device, most commonly defined as a
stroke or transient ischemic attack (TIA). This neurological safety profile
represents a potential unique advantage of C-Pulse as the device does not
contact the blood stream nor require blood thinning agents. To date, no other
known cardiovascular blood contacting mechanical support devices have shown
these results in a published pilot or pivotal clinical trial.
The Company has recently reported an additional two patients have been targeted
for weaning from the technology in addition to two previously weaned patients
that were permanently disconnected from the device based upon improvement in
their heart failure symptoms.
C-Pulse is designed to treat Class III and ambulatory Class IV heart failure.
The device utilizes proven balloon counterpulsation technology to assist the
heart by reducing the workload of the left ventricle. The device may be
implanted via a minimally invasive surgical procedure, which is generally
performed in an hour. A pre-sutured cuff is placed around the ascending aorta,
outside the patient's bloodstream. This strategic placement of the device is a
likely contributor to the neurologic safety profile relative to competitive
devices, reducing the risk of stroke incidence and blood clotting. Additional
advantages of the device include a durable cuff, with zero cuff failures being
recorded in the North American feasibility and European post-market trials; as
well as the ability of patients to seamlessly disconnect (and re-connect) from
the device based on symptom improvement, further enhancing patients' quality of
life.
C-Pulse is currently being evaluated in a U.S. pivotal trial, COUNTER HF, which
will enroll a total of 388 patients. Two sites have been activated in this
trial with ten additional sites in the activation process. A European
post-market study of the device is also underway in Europe, which will include
50 patients based on a similar trial design. One site is currently activated
with two patients already implanted and three additional sites are now capable
of enrolling. C-Pulse achieved CE Mark certification in July, 2012 based upon
the results of its U.S. feasibility study, which concluded in 2011.
About the C-Pulse(r) 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
counterpulsation applied in an extra-aortic approach to assist the left
ventricle by reducing the workload required to pump blood throughout thebody,
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 trial,
we also believe that some patients treated with our C-Pulse System will be able
to stop using the device due to sustained improvement in their condition as a
result of the therapy.
Caution: Investigational device, limited by Federal (or United States) Law to
Investigational use.
About Sunshine(r) 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 trial 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 trial. 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 a wholly owned subsidiary in Australia. 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 the net proceeds from the
offering, future clinical trial activities and results including patient
enrollment in trials. These forward-looking statements are subject to numerous
risks and uncertainties, including, without limitation, that the net proceeds
may be lower than we currently expect due to increased offering expenses or
otherwise, the possibility that our clinical trials 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 SEC. 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: For further information, please contact:
Media:
Laura Forman
Blueprint Life Science Group
T: +1-415-375-3340
Investor:
Jeff Mathiesen
Chief Financial Officer
Sunshine Heart, Inc.
T: +1-952-345-4200
News Source: NASDAQ OMX
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Language: English
Company: Sunshine Heart, Inc.
United States
Phone:
Fax:
E-mail:
Internet:
ISIN: US86782U1060
WKN:
End of Announcement DGAP News-Service
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Datum: 18.06.2013 - 11:15 Uhr
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