CONFIDENTIAL CorCap Cardiac Support Device (CSD) (P040049) Acorn ...
CLINICAL STUDY RESULTS. • The pivotal clinical trial of the CorCap CSD met all protocol-specified .... Assurance, Acorn Cardiovascular, Inc. June 1, 2006. ...
http://www.fda.gov/ohrms/dockets/AC/06/briefing/2006-4269b1_...
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Mitral valve surgery in heart failure: insights from the Acorn ...
... with and without the CorCap cardiac support device (Acorn Cardiovascular, ... the mitral valve repair or replacement stratum of the Acorn Clinical Trial;
... RESULTS: For the entire mitral valve surgery group, the 30-day operative ...
http://www.ncbi.nlm.nih.gov/pubmed/16935112...
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CorCap Cardiac Support Device (CSD) (P040049) Acorn Cardiovascular ...
Acorn maintains that another clinical trial is not needed .... Further clouding the interpretation of the study results was the fact that some patients ...
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4269b1_...
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News: Acorn Cardiovascular to Conduct 50-Patient Confirmatory ...
9 May 2007 ... Acorn Cardiovascular announced today that the Food and Drug ... population that demonstrated the greatest clinical benefit in the pivotal trial. ... Following a
six-month follow-up period and pending positive results, ...
http://www.genengnews.com/news/bnitem.aspx?name=17144661...
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The Acorn Cardiovascular Cardiac Support Device (CSD) Clinical Trial
NYHA Class I: There is clinical evidence of heart failure or some other cardiac disease, but the patient's physician activity is not limited by symptoms. ...
http://www.fda.gov/ohrms/DOCKETS/ac/05/briefing/2005-4149b1_...
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Sustained benefits of the CorCap Cardiac Support Device on left ...
... remodeling: three year follow-up results from the Acorn clinical trial. ... the CorCap Cardiac Support Device (CSD; Acorn Cardiovascular, Inc, St. Paul, ...
http://www.ncbi.nlm.nih.gov/pubmed/17888975...
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Novel "Heart Sock" Demonstrates Efficacy for Off-Loading Heart in...
7 Nov 2004 ... The results from the Acorn Clinical Trial of the CorCap CSD were reported here ... The device is made by Acorn Cardiovascular of St. Paul, ...
http://www.medscape.com/viewarticle/493312...
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One-year clinical experience with the Acorn CorCap cardiac support ...
Department of Cardiovascular Sciences, S. Maria della Misericordia Hospital, ... RESULTS: The LV end-diastolic diameter decreased from 69.3 +/- 7.2 to 60.1 +/-
9.0 mm ... Clinical Trial; Comparative Study; Multicenter Study. Mesh Terms: ...
http://www.ncbi.nlm.nih.gov/pubmed/15773275...
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I. SUMMARY OF SAFETY AND EFFECTIVENESS
15 Apr 2005 ... was initiated by Acorn Cardiovascular Inc., under the approved IDE .... interpretation of trial results, or receiving experimental or investigational
..... The CorCap CSD clinical trial, “Clinical Evaluation of Acorn ...
http://www.fda.gov/ohrms/DOCKETS/ac/05/briefing/2005-4149b1_...
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Neurohormonal and echocardiographic results after CorCap and ...
... CorCap Cardiac Support Device (Acorn Cardiovascular Inc, St. Paul, MN) and RMA. Clinical, echocardiographic, New York Heart Association (NYHA) ... BNP at
short-term follow-up together with slightly improved echocardiographic and
functional results. ... Comparative Study; Randomized Controlled Trial. Mesh
Terms: ...
http://www.ncbi.nlm.nih.gov/pubmed/19699885...
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