European Commercialization of Innovative Technology for Treatment of Heart Failure Slated to Begin in 2012
(KIRKLAND, WA), September 29, 2011—Cardiac Dimensions®, Inc. today announced
that it has received Conformité Européenne (CE) Mark approval for a newly
enhanced version of its CARILLON® Mitral Contour System®, a novel therapy
for treating heart failure patients suffering from functional mitral
regurgitation (FMR). Receipt of the CE Mark enables Cardiac Dimensions to
initiate a commercial launch of the enhanced device in Europe, which the
Company noted will begin in 2012.
The CE Mark approval follows the
successful completion of the AMADEUS and TITAN clinical trials of the
CARILLON system, which demonstrated significant reduction in FMR and
significant improvement in functional capacity and quality of life. An
additional trial with the enhanced version of CARILLON, called TITAN II, was
recently initiated to further the clinical experience.
“We are
delighted to have achieved this critical milestone, which allows us to
distribute CARILLON throughout Europe,” said Rick Stewart, President and
Chief Executive Officer of Cardiac Dimensions. “We believe CARILLON’s novel
approach to addressing FMR holds significant promise for the millions of
heart failure patients who suffer from this debilitating and progressive
condition. The CE Mark approval of CARILLON is a reflection of our rapidly
growing clinical experience, which suggests that this device is uniquely
positioned to reverse the course of heart failure in this largely
under-addressed patient population. Also, we are pleased to have the
opportunity to further substantiate our initial clinical experiences through
the commencement of the TITAN II trial.”
Janusz Lipiecki, M.D., of
Clinique Pôle Santé République in Clermont Ferrand, France, one of the TITAN
and TITAN II investigators, commented: “FMR secondary to left ventricular
dilatation is associated with poor prognosis and high rates of mortality. As
a new treatment option, CARILLON offers compelling and unique attributes
given its rapid percutaneous deployment and innovative use of natural
cardiac structures to reduce mitral annulus dimension. The elegance and
ingenuity behind the design allow for customization based on patient anatomy
as well as intra-operative assessment to ensure safety. From a clinical
perspective, patients have experienced early and sustained improvements that
suggest profound utility. I am pleased to hear of the recent CE Mark
approval and excited to serve as a TITAN II investigator and further
contribute to the clinical experience.”
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 and most of them 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: 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.
For further
information contact:
Cardiac Dimensions, Inc.
David Reuter
(425) 605-5960
Allen & Caron, Inc.
Matt Clawson
(949)
474-4300