Jun 7 2012
CardioKinetix Inc., a medical device company pioneering a catheter-based
treatment for heart failure, announced today that it has begun
enrollment in PARACHUTE III, a post-market safety surveillance trial, in
Germany with the CE Marked Parachute™ Ventricular Partitioning Device.
After a heart attack, many heart failure patients experience enlargement
of their left ventricle causing a decrease in cardiac output resulting
in heart failure symptoms such as shortness of breath. Treatment options
for patients whose ventricle has enlarged are limited. The Parachute
device offers the first minimally invasive catheter-based treatment to
partition the damaged muscle, excluding the non-functional heart segment
from the healthy, functional segment to decrease the overall volume of
the left ventricle and restore its geometry and function.
The first implants with CE Marked Parachute devices were done in
Heidelberg, Germany by Stefan Hardt, M.D., Department of Cardiology,
Heidelberg University Clinic as part of the PARACHUTE III trial, which
is designed to evaluate the long-term safety of the Parachute implant
in a real-world setting in up to 100 patients with ischemic heart
failure at up to 20 centers in Europe. Professor Hardt reported that all
patients were treated successfully and discharged without
procedure-related complications. A successful case was also performed by
Heyder Omran, M.D., Ph.D., Department of Cardiology and internal
Medicine, St. Marien-Hospital Abt. Innere Medizin in Bonn, Germany.
"The Parachute implant system represents an important
advancement in treatment options for patients with ischemic heart
failure," said Dr. Martyn Thomas, M.D., chairman of Cardiology at St.
Thomas Hospital in London, England, and the principle investigator for
the PARACHUTE III study. "These first procedures in the PARACHUTE III
trial represent the beginning of the largest clinical data evaluation
for this new therapy to date. I am optimistic that the patients treated
with the Parachute implant will experience positive results similar to
those in prior trials of the device most recently reported during the
2012 EuroPCR meeting."
CardioKinetix plans to continue expanding its post-marketing trial
effort in Europe by adding hospitals in the UK, Spain, Italy, Belgium,
Germany, and the Netherlands in coming months. The PARACHUTE III
clinical trial will enable physicians in the European Union to increase
their experience with the technology while continuing to develop the
therapy.
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