Commercial Rollout includes PRIME Study, Collecting Data on up to 300
European Patients
(KIRKLAND, WA), September 28, 2012—Cardiac
Dimensions®, Inc. today announced that it has initiated its commercial
efforts in Europe, treating the first patients with its CARILLON® Mitral
Contour System® under its Conformité Européenne (CE) Mark approval. The
CARILLON system is a novel, minimally invasive therapy for treating heart
patients suffering from functional mitral regurgitation (FMR). An estimated
70 percent of the 20 million people worldwide with heart failure also suffer
from FMR.
As part of the commercial rollout, the patients have been
enrolled in the PRIME (Percutaneous Repair in Functional Mitral
Regurgitation) Study, a prospective, multicenter post-market study registry
that builds on the clinical experience from Cardiac Dimensions’ AMADEUS,
TITAN and TITAN II studies. Long-term safety and efficacy will be evaluated
in the PRIME study through the assessment of hemodynamics, functional
capacity, heart failure hospitalizations as well as quality of life in up to
300 patients.
To support commercial efforts, Cardiac Dimensions has
established direct operations in Europe, including a dedicated sales and
clinical team focused exclusively on the successful rollout of the CARILLON
system.
“Initiation of commercial sales represents a major milestone
for Cardiac Dimensions,” stated Rick Stewart, Chief Executive Officer. “We
have spent the last few months preparing our organization for successful
training, sales, distribution and clinical support of the CARILLON
technology and are receiving a very warm reception from our early physician
customers. In addition to general excitement around the minimally invasive
CARILLON treatment, our physicians have also expressed a strong interest in
participating in additional clinical studies. With the compelling outcomes
expressed in TITAN and early positive signals coming from TITAN II, this
bodes well as we begin the PRIME study.”
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. Clinical data suggests 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, CARILLON and Mitral Contour System are registered trademarks of
Cardiac Dimensions, Inc.