THE WOODLANDS, Texas & BERLIN–(BUSINESS WIRE)–The Berlin Heart Group announced today that the FDA has granted
“Humanitarian Device Exemption” (HDE) approval of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD).
The Berlin Heart EXCOR® Pediatric VAD is a mechanical
cardiac support system for critically ill pediatric patients suffering from
severe heart failure. The system is designed to support pediatric patients of
all age groups, from newborns to teenagers, and is intended to bridge patients
awaiting heart transplantation from days up to several months, until a donor
heart becomes available. The Berlin Heart EXCOR® Pediatric VAD, which has
previously been approved for use in Europe and Canada,
is now the only Ventricular Assist Device that is designed specifically for the
pediatric population to be approved in the United States.
The National Principal Investigator for the Berlin Heart
EXCOR® Pediatric VAD study, Charles D. Fraser, Jr., M.D., Surgeon-In-Chief and
Head of the Division of Congenital Heart Surgery at Texas Childrens Hospital
and Professor of Surgery and Pediatrics, Baylor College of Medicine in Houston,
Texas, said, “On behalf of the many investigators, coordinators, and
administrative personnel involved in the study, I am extremely gratified by the
news that the EXCOR® Pediatric VAD has achieved an HDE approval by the FDA.
This is a landmark event for children suffering from terminal heart failure.
The medical community is now able to offer this lifesaving device to support
desperate children who would not otherwise survive while awaiting a heart
transplant. This ushers in a new era for children with heart disease. The study
involved an incredible effort from 15 centers across North American with
extensive experience in pediatric heart failure and transplantation and should
serve as a model for future collaborative device investigations involving
children, industry, medicine, and the FDA.”
Dr. Stefan Thamasett, Chairman of the Board of Berlin Heart,
said, “This milestone marks the closure of a long process, and we are very
happy that we were able to reach this for the Berlin Heart Group. Our special
thanks goes to all of the participating clinics and their doctors as well as
our countless patients and their relatives; and of course we would like to
thank our employees, because without their tireless commitment we would not
have been able to reach this goal. We are looking forward to a new and exciting
chapter in the history of Berlin Heart.”
Bob Kroslowitz, President and CEO of Berlin Hearts North
American operations, added: “Being granted HDE approval is an outstanding
achievement for the whole Berlin Heart team. The FDA worked effectively with
Berlin Heart to refine the design of the clinical trial that resulted in a
meaningful study with useful conclusions. With the approval, we are now able to
more readily offer this important lifesaving technology to this most important
patient population. We are grateful and need to especially thank our study
sites, our investigators and most importantly, the families of the children
that participated in the study. Additionally, without the support of my
colleagues in Berlin and the Berlin Heart team
in the US,
especially Mary Beth Kepler, Vice President of Regulatory Affairs, the approval
could have never been achieved.”
The EXCOR® Pediatric VAD clinical study, which enrolled the
first patient in November 2007, is the first prospective clinical trial ever
conducted to investigate the safety and benefit of a Ventricular Assist Device
in the pediatric population. Full enrollment of the trial took approximately 33
months. The following US centers participated in the IDE study: Arkansas
Childrens Hospital (AR), Boston Childrens Hospital (MA), Childrens
Healthcare of Atlanta (GA), Childrens Hospital of Wisconsin (WI), The
Childrens Hospital of Denver (CO), Lucille Packard Childrens Hospital at
Stanford (CA), Mott Childrens Hospital (MI), Mount Sinai Hospital (NY),
Pittsburgh Childrens Hospital (PA), Riley Childrens Hospital (IN), Seattle
Childrens Hospital (WA), St. Louis Childrens Hospital (MO), Texas Childrens
Hospital (TX), Childrens Hospital at the University of Alabama at Birmingham
(AL), and the University of Minnesota at Fairview (MN).
About Berlin Heart
Berlin Heart GmbH is the only company worldwide that develops, produces, and
distributes implantable and external ventricular assist devices (VADs) for
patients of every age and body size. The company offers pumps, cannulas, and
external components for internal and external use to stabilize cardiac activity
in acutely ill patients. Its products are market leaders in their respective
segments in Germany and in Europe. The company also manufactures the implantable
left ventricular assist device INCOR®, which has been designed for long-term
application in adult patients. The longest the device has supported a patient
to date is more than five years and ongoing. INCOR® is not FDA-approved, but
widely used in Europe.
Berlin Heart Inc., the companys US subsidiary, was founded in 2005
to support the North American centers. Further product information is available
from the company website: www.berlinheart.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
