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.
Allen & Caron, Inc.