The Woodlands, Texas, U.S.A. – Berlin Heart announced recently that a study published in the current issue of the New England Journal of Medicine (NEJM) concludes that survival using the Company’s EXCOR Pediatric Ventricular Assist Device (VAD) is “significantly greater” than the standard-of-care (extracorporeal membrane oxygenation, or “ECMO”) as a “bridging therapy” for children in need of a heart transplant.

The principal author, Charles D. Fraser, Jr., M.D., Surgeon-In-Chief and Head of the Division of Congenital Heart Surgery at Texas Children’s Hospital, and Professor of Surgery and Pediatrics at Baylor College of Medicine served as the National Principal Investigator for the clinical trail.

The trial was a prospective, multi-center, single-arm cohort study. Children implanted with the EXCOR Pediatric VAD as a bridge to cardiac transplantation were compared to a historical control group of children supported by ECMO that were selected from the Extracorporeal Life Support Organization registry. Seventeen pediatric cardiac centers in the United States and Canada participated in the trial.

A total of 48 patients in need of support (ages 16 and under) were divided into two cohorts based on body size. Each cohort included 24 patients, Cohort 1 the “smaller” participants and Cohort 2, the “larger” participants. Among participants in Cohort 1, median time of support was 27 days in contrast to the matched ECMO control median support time of 5 days.  In Cohort 2, the median support time was 43 days whereas the ECMO control group was supported a median of 5 days. Overall, 88% of participants in Cohort 1 and 92% of participants in Cohort 2 survived to either heart transplantation or weaning with the use of the EXCOR Pediatric Ventricular Assist Device.

“The EXCOR Pediatric Ventricular Assist Device represents a major medical advance in the treatment of children who need a heart transplant,” said Dr. Fraser. “Most of these babies and children would not otherwise survive without the support of EXCOR while awaiting donor hearts. I know that I speak for all of the medical professionals who participated that we are tremendously gratified to have been a part of this ground-breaking study.”

“Until the FDA approved EXCOR, options for mechanical circulatory support as a bridge to heart transplantation in children with severe heart failure were finite,” added Robert Kroslowitz, President and CEO of Berlin Heart’s North American operations. “More specifically, the effective period of ECMO support is typically limited to only 10 days before life-threatening complications ensue that often preclude transplantation.

The narrow duration of support afforded by ECMO is often inadequate considering current waiting times for a pediatric heart transplant (a median of 119 days for all infants in 2008). Consequently, less than 50% of the children supported on ECMO survive to undergo heart transplantation.”

“Publication of the EXCOR study results in one of the most esteemed peer-reviewed medical journals in the world offers strong testimony that the FDA’s recent approval of EXCOR represents a landmark event for children suffering from terminal heart failure,” said Kroslowitz. “Indeed, the worldwide medical community is now offered this lifesaving device to support desperate children who would not otherwise survive while waiting for a heart transplant.  No doubt, EXCOR represents a new era for treating children with heart disease.”

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 to many months, until a donor heart becomes available. The FDA granted “Humanitarian Device Exemption” (HDE) approval of Berlin Heart’s EXCOR Pediatric VAD in December 2011. The device is also approved for use in Europe and Canada.

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Few hospitals have as much experience with the Berlin Heart as DMC Children’s Hospital of Michigan. This is why the U.S. Food and Drug Administration (FDA) was eager to hear testimony from Henry L. Walters III, MD, chief of cardiovascular surgery at DMC Children’s Hospital of Michigan. Dr. Walters provided testimony about the device at a recent public hearing.

After reviewing the clinical trial data and hearing testimony from Dr. Walters and others, the device has now been approved. The Berlin Heart is the first ventricular assist device made specifically for pediatric patients. Ventricular assist devices are common in adults. But, until recently, they weren’t manufactured in pediatric sizes.

Ventricular assist devices are used when a patient needs a heart transplant, but can’t wait for a donor heart to become available. The Berlin Heart assists the failing heart until an appropriate donor heart can be found.

“A few times a year, we are faced with a situation where a child simply can’t wait for a heart transplant,” Dr. Walters said. “In these cases, the Berlin Heart works very well and the children generally stabilize and start to thrive and improve while they wait for a donor heart.”

Before the device was approved by the FDA, Dr. Walters and his colleagues used the Berlin Heart under the FDA’s “compassionate use” regulations. Since 2005, Dr. Walters and his colleagues have inserted 14 Berlin Hearts. Of the 14 patients, 10 survived to cardiac transplantation and nine of the patients are thriving today – a result directly attributable to the efficacy of the Berlin Heart. The nine survivors ranged in age from 6 months to 13 years.

Before availability of the Berlin Heart, Dr. Walters and his colleagues occasionally adapted an adult ventricular assist device for use in a child, but the results were not optimal and some patients were too small for a modified adult device.

“The Berlin Heart stands alone in filling a tremendous void in the field of pediatric cardiac failure. I can honestly say that of our nine survivors, eight were too small to have possibly accommodated any of the available adult ventricular assist devices. For these patients the Berlin Heart was truly the key to their survival,” adds Dr. Walters.

The pediatric heart transplant program at the DMC Children’s Hospital of Michigan is the largest in the state of Michigan and one of the largest in the Midwest. For 125 years the DMC Children’s Hospital of Michigan is the first and most experienced hospital in the state dedicated exclusively to the treatment of children.

A leader internationally in neurology and neurosurgery, cardiology, oncology, and diagnostic services, it is ranked one of America’s best hospitals for children. More Michigan pediatricians are trained at the Children’s Hospital of Michigan than in any other facility.

Children’s Hospital of Michigan is one of eight hospitals operated by the Detroit Medical Center (DMC). The DMC is proud to be the Official Healthcare Services Provider of the Detroit Tigers, Detroit Red Wings and Detroit Pistons.

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