|[December 18, 2012]
CardiacAssist Receives FDA IDE Approval for Use of the TandemHeart System in Pivotal Clinical Study
PITTSBURGH --(Business Wire)--
CardiacAssist, Inc., a privately-held medical technology company
headquartered in Pittsburgh, Pennsylvania, announced today that it
received Investigational Device Exemption (IDE) approval from the Food &
Drug Administration (FDA) for a pivotal clinical study of the
TandemHeart circulatory support system. The TandemHeart to Reduce
Infarct Size (TRIS) Trial will evaluate the effectiveness of ventricular
unloading on the reduction of infarct size for patients who have
suffered a severe heart attack.
"The approval of the pivotal TRIS Trial represents a major milestone for
our company and the industry," said John Marous, President & CEO of
CardiacAssist. "With the completion of our pre-clinical animal studies,
which showed a strong correlation between high degrees of ventricular
unloading and improved myocardial salvage, we are excited to extend this
concept to human trials and hopefully achieve similar clinical benefits."
Patients enrolled in the TRIS Trial will be randomized to receive either
conventional therapy or a TandemHeart devce to unload the left
ventricle along with percutaneous coronary intervention (PCI (News - Alert)). The
primary efficacy endpoint of the study is improvement in myocardial
salvage index (MSI). Additionally, the economic impact of TandemHeart
therapy will be studied through secondary endpoints including long term
mortality and the rates of repeat hospitalization and implantable
cardioverter-defibrillator (ICD) usage. A reduction in these rates could
decrease the total cost of treatment for this patient population.
The TRIS Trial is expected to begin enrollment in early 2013 and will
include up to 20 hospitals, with leadership from Principle Investigators
Biswajit Kar, M.D., Chief of the Center for Advanced Heart Failure at
Memorial Hermann Heart and Vascular Institute in Houston, Texas, and
David Holmes, M.D., Professor of Medicine at the Mayo Clinic College of
Medicine in Rochester, Minnesota, and Immediate Past President of the
American College of Cardiology (ACC).
For more information about the TRIS Trial, visit http://www.cardiacassist.com/innovation-research/tris-trial/.
The FDA-cleared TandemHeart system has provided critical heart support
to thousands of patients in the top cardiac centers worldwide. The
system's unique left atrial cannulation creates a fully percutaneous
extracorporeal blood circuit to bypass the left ventricle, augmenting
the flow of blood by up to 5.0 L/min.
Headquartered in Pittsburgh, PA, privately-held CardiacAssist is a
growing medical technology company that developed the world's first
FDA-cleared and CE-marked short-term extracorporeal circulatory support
system for both cardiologists and cardiac surgeons.
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