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Findings From Single Center Highlight Minimally Invasive Thoracotomy Implantation Technique of Novel Counter-Pulsation Cardiac Device

Thu, 05/31/2012 - 4:45am
The Associated Press

Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC), a global medical device

company focused on innovative technologies for moderate to severe

heart failure, today announced data from a single center participating

in the U.S. Food and Drug Association (FDA) feasibility clinical trial

for the C-Pulse@ Heart Assist System will be presented at the 2012

International Society of Minimally Invasive Cardiothoracic Surgery

(ISMICS) Annual Meeting in Los Angeles, May 30-June 2, 2012. Findings

from a single center utilizing the C-Pulse System demonstrated that

the device can be safely implanted utilizing a minimally invasive

approach. The C-Pulse System is a new investigational therapeutic

approach based on proven balloon counter-pulsation technology for the

treatment of patients with Class III and ambulatory Class IV heart

failure.

The data will be presented by Sanjeev Aggarwal, M.D., director of

Mechanical Circulatory Support at St. Luke's Mid America Heart

Institute, during the cardiac track on heart failure. The oral

presentation, titled "Results of the C-Pulse Prospective Feasibility

Study for the Treatment of Ambulatory Heart Failure Utilizing A

Minimally Invasive Thoracotomy Implantation Technique," will be held

Saturday, June 2 at 8:30-9:50 a.m. PDT.

"The C-Pulse device represents an important advance in the treatment

of patients suffering from heart failure," said Dr. Aggarwal. "It

offers the opportunity to provide a means of mechanical circulatory

support using a minimally invasive procedure without direct blood

contact, offering a favorable risk profile without the need for

systemic anticoagulation."

Five patients underwent implantation of the C-Pulse System at a single

institution participating in the FDA approved investigational device

exemption (IDE) prospective feasibility study. Primary safety

endpoints included death, aortic disruption, neurologic events,

myocardial infarction and major infection at six months. Quality of

life was assessed using Minnesota Living with Heart Failure (MLWHF)

and Kansas City Cardiomyopathy Questionnaire (KCCQ). One patient

underwent implantation of the device using a hemi-sternotomy approach.

Four patients underwent placement using a limited right parasternal

thoracotomy incision, leaving the sternum intact. All patients were

New York Heart Association (NYHA) Class III at baseline, with

non-ischemic etiology in four out of five patients. Mean follow-up was

351 days (range 64-498) with 1,754 total patient days with four

patients still on device therapy.

The findings showed significant improvements at 6 months in MLWHF

scores [baseline mean 50 (range 20-71) versus mean 31 (range 5-49) at

6 months] and KCCQ scores [baseline mean 56 (range 37-81) versus mean

69 (range 52-92)]. There was also a one to two class improvement in

NYHA in the majority of the patients. There were no deaths, aortic

disruptions, neurologic events, myocardial infarctions or mediastinal

infections reported.

"Dr. Aggarwal was the leading implanter of the C-Pulse System and we

want to thank him and the staff at St. Luke's Mid America Heart

Institute for their support during and after the trial," said Dave

Rosa, chief executive officer of Sunshine Heart. "We are encouraged by

the results from the feasibility trial and we look forward to further

studying the device in a prospective, multi-center, randomized control

trial. We are on track to begin the U.S. pivotal trial in the second

half of 2012."

About Class III Heart FailureHeart failure is a common condition in

which the heart becomes unable to pump sufficient blood to meet the

body's needs. More than five million people in the United States have

heart failure, resulting in more than 300,000 deaths each year(1).

Heart failure is a progressive condition and typically results from

damage to the heart muscle arising from a heart attack or virus.

Cardiologists use the New York Heart Association (NYHA) 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. More than 1.5 million U.S. heart failure patients are

in the Class III or moderate heart failure category which is defined

by the limitation of physical activity(2). 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. These

standard treatments often do not resolve the progression of heart

failure leaving patients without any additional options, hence the

need for new treatments for patients living with the disease.

About The C-Pulse@Heart Assist SystemThe C-Pulse@ Heart Assist System,

an investigational device, utilizes the proven 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. Operating outside the patient's

bloodstream, the novel extra-aortic approach of the C-Pulse technology

offers greater flexibility allowing patients to disconnect as

necessary or desired. The C-Pulse System's potential benefits may help

reverse the heart failure process or maintain the patient's current

condition, which may reduce the need for later stage heart failure

therapies, such as left ventricular assist devices (LVADs), artificial

hearts or transplants.

Caution - Investigational device. Limited by Federal (or United

States) law to investigational use.

About Sunshine Heart@ Sunshine Heart, Inc. (NASDAQ: SSH) (ASX: SHC) is

a global medical device company committed to the commercialization of

the C-Pulse Heart Assist System, an implantable, non-blood contacting,

heart assist therapy for the treatment of moderate to severe heart

failure. The C-Pulse System can be implanted using a minimally

invasive procedure and is designed to relieve the symptoms of heart

failure through the use of counter-pulsation technology, which enables

an increase in cardiac output, an increase in coronary blood flow and

a reduction in the heart's pumping load. The Company 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. Sunshine Heart is a Delaware corporation headquartered in

Minneapolis with a subsidiary presence in Australia. The Company has

been listed on the ASX since September 2004 and on NASDAQ beginning

February 2012. For more information, please visit

www.sunshineheart.com(http://www.sunshineheart.com/).

Forward-Looking Statements Certain statements in this report are

forward-looking statements that are based on management's beliefs,

assumptions and 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 product development and

commercialization efforts, results of clinical trials, timing of

regulatory filings and approvals, regulatory acceptance of our

filings, research and development activities, ultimate clinical

outcomes and benefits of our products to patients, market and

physician acceptance of the products, intellectual property

protection, and potentially competitive product offerings. The risk

factors described in our filings with the U.S. Securities and Exchange

Commission (SEC) and ASX could cause actual events to adversely differ

from the expectations indicated in these forward-looking statements.

Management believes that these forward-looking statements are

reasonable as and when made. However, you should not place undue

reliance on forward-looking statements because they speak only as of

the date when made. Sunshine Heart does not assume any obligation to

publicly update or revise any forward-looking statements, whether as a

result of new information, future events or otherwise. Sunshine Heart

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. Forward-looking statements are subject

to a number of risks and uncertainties, including without limitation,

the possibility that regulatory authorities do not accept our

application or approve the marketing of the C-Pulse Heart System, the

possibility we may be unable to raise the funds necessary for the

development and commercialization of our products, and those described

in our filings with the ASX and SEC. We may update our risk factors

from time to time.

(1)

http://www.nlm.nih.gov/medlineplus/heartfailure.html(http://www.nlm.nih.gov/medlineplus/heartfailure.html)

(2) LSI (Life Science Intelligence) Report, # 0515-1-US-1010-206,

11/2010

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