SecProbe.io

October 27, 2011
 Jeff Mathiesen Chief Financial Officer Sunshine Heart, Inc. 7651 Anagram Drive  Eden Prairie, Minnesota
Re: Sunshine Heart, Inc.
 Form 10
Filed September 30, 2011 File No. 001-35312

Dear Mr. Mathiesen:
 We have reviewed your filing and have the following comments.  In some of our
comments, we may ask you to provide us with  information so we may better understand your
disclosure.
 Please respond to this letter by amendi ng your filing, by providing the requested
information, or by advising us when you will provide the requested response.  If you do not believe our comments apply to your facts and circ umstances or do not believe an amendment is
appropriate, please tell us why in your response.
 After reviewing any amendment to your filing and the information you provide in
response to these comments, we ma y have additional comments.

General

 1. Please note that the Form 10 goes effective by lapse of time 60 days after the original
filing date, pursuant to Section 12(g)(1) of  the Securities Exchange Act of 1934.  Upon
the expiration of this 60-day time peri od, you will be subject to the reporting
requirements under Section 13(a) of the Securiti es Exchange Act of 1934.  In such event,
we will continue to review your  filing until all of our comments have been addressed.  If
this filing was made voluntarily, you should cons ider withdrawing it prior to the effective
date if comments remain outstanding.  You could then refile when you are prepared to
resolve the comments.  If so, please file your request for withdrawal before the automatic
effectiveness date.
Market Data, page i

 2. With regard to third party data referenced  throughout, please provide copies of these
industry publications, surveys, and other sources of statistics, clearly marking the relevant

Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 2

 sections of these reports.  Al so, please tell us whether these materials were prepared at
your request or in connection with  the registration statement.

Item 1 – Business, page 1

 3. Please revise this section to describe the distribution methods for your products, whether
you manufacture your products, sources and ava ilability of raw materials and the names
of principal suppliers.  In this regard, we note your risk factor, “We depend on a limited
number of manufacturers and s uppliers…” on page 10.  In add ition, revise to describe the
terms of any material agreements.
 Our Product, page 2

 4. Please revise to describe in greater detail  how your product will be used.  For example,
we note your statement that your product may be turned on or off at any time allowing
the patient intervals of freedom to perfor m certain activities.  Please revise your
disclosure to discuss whether th e product is expected to be us ed all the time or for certain
hours and whether the product can be used at  home by a patient or whether use of your
product requires a visit to a medical facility.  Please also revise to  disclose specifically
the types of activities which are allowable and the restrictions on activities when the
product is turned on or off.
 5. We note that your product is implanted between the patient’s ribs and sternum.  Please
reconcile the implantation of the device with your statements that the device “does not
directly contact th e patient’s blood.”
 Clinical Development, page 2

 6. We note your statements on page 25 that you have completed enrollment in your
feasibility clinical trial.  Please revise to discuss any results from the current feasibility
study and the status of the study.  If you have conducted other clinical trials, please revise
to discuss the dates and results of those clinical  trials, as well.  In addition, please discuss
the status of your IDE app lication, including the remaini ng hurdles to approval.
 7. We note also your statement on page 1 that you are seeking CE Mark approval for your
product and that you anticipate that you will obtain approval in early 2012.  Please revise
to describe the status of your CE Mark appr oval, the steps you have taken to seek CE
Mark approval and the steps which still need to be taken before approval.
 Sales and Marketing, page 3

 8. Please revise to clarify the “initial steps”  you have taken to de velop a network of
physicians and clinics in Europe.

Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 3

 Competition, page 4

 9. We note that your disclosure describes onl y the perceived advantages of your product
relative to the competition.  Please also desc ribe the competitive disadvantages of your
product relative to other products used at the same or earlier stages of heart failure. If you
are unable to identify the disadvantages, a dd appropriate disclosure stating that the
efficacy of your product, including potentia l competitive disadvantages, is not known.
 Comparison of Year Ended December 31, 2010 to Year Ended December 31, 2009

Revenue, page 26
 10. Please revise to clarify wh ether all of the revenues earned during the years ended
December 31, 2010 and December 31, 2009 resulted fr om your feasibility clinical trial.

Sources of Liquidity, page 27

 11. When note that your current funds are sufficien t to continue your operations “into 2012.”
Please specify when you expect to require ad ditional funds and describe the course of
action you propose to take in order to obtain additional financing.

Item 5 – Beneficial Owners of More than  Five Percent of ou r Common Stock, page 29

 12. Please revise to identify the natural persons  with voting or inve stment power over the
shares beneficially owned by entities listed in the table.
 Directors and Executive Officers, page 29

 13. Please revise the table to include Nicholas Ca llinan’s position as Chairman of the Board.
 Directors, page 30

 14. Please revise Paul Buckman’s biography to de scribe briefly the principal business of
Pathway Medical Technologies, Inc.  Please al so revise to specify the dates when Dr.
Mark Harvey and Donal O’Dwyer served as directors of the entities listed in their
respective biographies.
Item 6 – Executive Compensation, page 33

 15. Please revise to describe how the board set th e salary of Dr. Peters and Debra Kridner,
given that there are no employment agreements with these individuals.

Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 4

 Related Party Transactions, page 37

 16. We note section 2 of Exhibit 10.15.  Please revise to describe in greate r detail the services
that WSP provides.  Additionally, please revise to clarify that this agreement requires that
Williams Peter serve as your Medical Di rector and Chief Technical Officer.

Item 9 – Market Price of and Dividends…, page 37

 17. We note your disclosure that 235,634,277 shares  of your common stock may be sold by
your existing stockholders without  restrictions under Rule 14 4. Please revise to clarify
whether this number includes those shares owned by your affiliates.
 Common Stock, page 49

 18. We note your statement that you are aut horized to issue up to 196,000,000 shares of
common stock.  However, we note Article IV.A  of your Articles of Incorporation which
states that you are authorized to is sue 1,960,000,000 shares of common stock.  Please
revise.
Financial Statements, page F-1

Note 4.  Income Taxes, page F-12
 19. We note your disclosures regarding the r ecognition of a $670,000 tax benefit in 2010 as a
result of your foreign subsidiary’s R&D tax cr edit rebate.  With a view toward enhanced
disclosure, please explain to us in greater  detail the nature of the rebate and the
circumstances surrounding your recognition of it only during that pe riod.  Tell us what
your expectations are for future  rebates considering anticipated increases  in research and
development expenses and e xpected continued losses.
 Exhibits

 20. Please tell us why you have not filed your  lease agreements for your corporate
headquarters in Eden Prairie, Minnesota and your office space in St. Leonards, New
South Wales, Australia.  We urge all persons who are responsible for th e accuracy and adequacy of the disclosure
in the filing to be certain that the filing include s the information the Securities Exchange Act of
1934 and all applicable Exchange Act rules requir e.  Since the company and its management are
in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy
and adequacy of the disclosures they have made.

Jeff Mathiesen Sunshine Heart, Inc. October 27, 2011 Page 5

  In responding to our comments, please provi de a written statement from the company
acknowledging that:
 the company is responsible for the adequacy an d accuracy of the disclo sure in the filing;

 staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filing; and

 the company may not assert staff comments as  a defense in any proceeding initiated by
the Commission or any person under the federa l securities laws of  the United States.

You may contact David Burton at (202) 551-3626 or Lynn Di cker, accounting reviewer,
at (202) 551-3616 if you have questions regard ing comments on the financial statements and
related matters.  Please cont act Allicia Lam at (202) 551-33 16 or Daniel Morris, Special
Counsel, at (202) 551-3314 w ith any other questions.

Sincerely,
   /s/  Daniel Morris for
Amanda Ravitz Assistant Director
cc (by e-mail): Matthew R. Kuhn -- Faegre & Benson LLP