KIRKLAND, Wash., Oct. 11, 2011 /PRNewswire/ -- Cardiac Dimensions®, Inc. today announced the first patient has been enrolled and successfully treated in the TITAN II clinical trial, a follow-up to the landmark TITAN clinical trial of the Company's CARILLON® Mitral Contour System™. TITAN II is a prospective, single-arm clinical trial initiated to further evaluate an enhanced version of the CARILLON system, a novel therapy for treating heart failure patients suffering from functional mitral regurgitation (FMR).
During TITAN II, 30 patients across five sites will be implanted with the CARILLON system and subsequently followed for a one-year period. The initial 53-patient TITAN clinical trial demonstrated significant relief from FMR and improvements in functional capacity and quality of life compared to a contemporaneously-enrolled control group. The initial trial also demonstrated a low 30-day adverse event rate of 1.9 percent.
"We could not be more pleased with the results that were established as part of the initial TITAN clinical trial," stated Rick Stewart, President and Chief Executive Officer of Cardiac Dimensions. "The data demonstrated an exceptionally low major adverse event profile while showing significant improvement in functional capacity and quality of life. Our investigators believe that the early and sustained improvement in parameters indicative of reverse cardiac remodeling in this severely ill patient population was also a clinically significant finding. They are eager to further their understanding of this process through the TITAN II trial."
TITAN II investigator Professor Dr. Michael Haude of Lukaskrankenhaus in Neuss, Germany, commented: "We are excited to be involved in the TITAN II study, which comes on the heels of the landmark TITAN trial. This first patient presented with severe FMR secondary to advanced heart failure, placing him at significant risk f
|SOURCE Cardiac Dimensions, Inc.|
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