Clinical expansion marked by first implant in the recently approved
INTEGRAL Trial, continuing use of the CARILLON System for Percutaneous
Treatment of Functional Mitral Regurgitation.
KIRKLAND, WA – May
4, 2011 - Cardiac Dimensions®, Inc. announced today the initiation of two
new clinical studies using the CARILLON® Mitral Contour System®, an
investigational device for percutaneous treatment of Functional Mitral
Regurgitation (FMR). The CARILLON system is a minimally invasive device
designed to repair the heart’s mitral valve and reduce FMR, a disorder that
affects most of the estimated 5 million people in the U.S. and more than 20
million people worldwide suffering from heart failure.
The INTEGRAL
Trial will assess safety and efficacy of the CARILLON device at one, three,
six and 12 months by evaluating reduction in FMR, heart size and
corresponding improvements in exercise capacity. The TITAN II study of the
CARILLON Mitral Contour System is an extension of the Company’s recent
TITAN™ trial.
Rick Stewart, President and CEO of Cardiac Dimensions,
said the very promising follow-up results from previous clinical studies of
the CARILLON system have prompted the Company to expand its clinical trial
efforts and prepare for European commercialization of the device in the near
future.
“We are very pleased with the positive feedback we are
receiving from physicians and patients involved in our clinical trials,”
Stewart said. “The fact that these patients, who have very few options
available for treating FMR, are responding so well underscores our belief in
the importance of our CARILLON device. Promising results and the ease of use
of the device have also generated strong physician interest in moving
forward with further clinical studies.”
Cardiac Dimensions also
announced that Adrian Ebner, M.D., the principal investigator of the
INTEGRAL trial, successfully performed the first implant using the CARILLON
system. Dr. Ebner performed the procedure at the Italian Hospital in
Asuncion, Paraguay on a 32-year-old man with moderate mitral regurgitation
(MR) caused by his dilated cardiomyopathy.
"The patient had been in
the hospital for several weeks prior to the procedure, but after the
CARILLON procedure we saw an immediate improvement in MR,” Dr. Ebner said.
“The patient also indicated improvement in his heart failure symptoms as
early as the following day."
Dr. Ebner has had prior experience with
the CARILLON device and continues to follow patients implanted with the
device during an earlier study. “I am extremely happy to again continue my
involvement with this therapy, as it represents a simple percutaneous option
to resolve a serious condition for a very large patient population,” Dr.
Ebner added.
About the CARILLON® Mitral Contour System
The investigational CARILLON® Mitral Contour System® combines a proprietary
implantable device and delivery system. The implant consists of a shaping
ribbon between distal and proximal anchors. It is delivered percutaneously
via jugular vein access under fluoroscopic guidance. The implant is designed
to be positioned, adjusted and gently anchored in the coronary sinus to
reshape the annulus around the mitral valve, thereby reducing mitral
regurgitation. Multiple clinical studies have shown that the reduction in
mitral regurgitation is associated with improvements in other key functional
parameters including NYHA class, 6 Minute Walk distance, and Quality of
Life.
About Cardiac Dimensions®, Inc.
Cardiac
Dimensions, based in Kirkland, Washington, develops and manufactures devices
designed for treating functional mitral regurgitation, heart failure and
related conditions. For further information visit the Cardiac Dimensions,
Inc. website at www.cardiacdimensions.com.
For further
information contact:
Cardiac Dimensions, Inc.
David Reuter
(425) 605-5960
Allen & Caron, Inc.
Matt Clawson
(949)
474-4300