Healthcare Industry News:  mitral regurgitation 

Devices Interventional Cardiology

 News Release - October 11, 2011

Cardiac Dimensions Announces First Patient Treated in TITAN II Clinical Trial

Trial to Further Evaluate Enhanced CARILLON® Mitral Contour System™ As Treatment for Heart Failure

KIRKLAND, Wash., Oct. 11, 2011 -- (Healthcare Sales & Marketing Network) -- 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 for early mortality and repeat hospitalizations. The CARILLON device was easily deployed in a cath lab setting. Notably, we were able to confirm safety and benefit to the patient intra-operatively. The novel CARILLON technology presents an attractive option for this patient's condition and the millions of others who suffer similarly from heart failure. Collaborating with the other investigational sites in completing enrollment in the TITAN II trial will allow the broader clinical community to obtain a robust understanding of this nascent and exciting technology."

About CARILLON® Mitral Contour System™

Cardiac Dimensions' CARILLON Mitral Contour System combines a proprietary, implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart's natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing functional mitral regurgitation (FMR). Rapidly delivered via the venous vasculature, CARILLON has the potential to treat most heart failure patients in a minimally invasive fashion. Early clinical data suggest that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life.

About Functional mitral regurgitation

More than 20 million people worldwide have heart failure, most of whom also suffer from functional mitral regurgitation (FMR). FMR typically results from the dilation of the left ventricle, which is the main pumping chamber in the heart. As the left ventricle increases in size, the mitral valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle and on to the body and its organs. FMR has been associated with high rates of mortality, reduced functional capacity, poor quality of life and an increase in patient hospitalizations. Current mainstream therapies to address FMR are limited. A majority of patients become refractory to medical therapy over time and traditional surgical intervention is associated with high rates of operative morbidity and mortality.

About Cardiac Dimensions®, Inc.

Cardiac Dimensions is a leader in the development of innovative, minimally invasive treatment modalities to address heart failure and related cardiovascular conditions. The company's initial technology platform, the CARILLON® Mitral Contour System™ has been designed to address functional mitral regurgitation, utilizing a novel percutaneous approach. Cardiac Dimensions is based in Kirkland, Washington. For more information, visit the company's web site: http://www.cardiacdimensions.com.

Cardiac Dimensions and CARILLON are registered trademarks of Cardiac Dimensions, Inc., and Mitral Contour System is a trademark of Cardiac Dimensions, Inc.


Source: Cardiac Dimensions

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