July 27, 2011 – A special panel convened July 21 in Gaithersburg, Md., to review the results of the Excor pediatric ventricular assist device (VAD) investigational device exemption (IDE) clinical trial. The panel convened at the request of Bram Zuckerman, M.D., director, division of cardiovascular devices, Center for Devices and Radiologic Health of the U.S. Food and Drug Administration (FDA).
The specific charge of the panel was to review the clinical data from the trial and to make recommendations to the FDA concerning the safety and probable benefit of the Excor as it pertains to an application for humanitarian device exemption (HDE) approval. This 22-member panel was composed of a group of experts in pediatric and adult cardiology, pediatric and adult cardiac surgery, neurology, biostatistics and other areas of expertise. It also included patient, consumer and industry representatives. The panel was chaired by Clyde Yancy, M.D., chief of the division of cardiology, Northwestern University School of Medicine in Chicago.
In preparation for presenting the study results to the panel, a team representing Berlin Heart and the investigation was assembled. Working together over several months, including several face-to-face meetings, this group, now referred to as the Berlin Heart "Dream Team," worked very hard to be well prepared. The main presentation and the bulk of the clinical data and trail results was presented to the panel by the national principal investigator of the study, Charles D. Fraser, Jr., M.D., FACS, surgeon-in-chief, congenital heart surgery, Texas Children's Hospital and professor of surgery and pediatrics, Baylor College of Medicine; and Charles E. Canter, M.D., medical director, Heart Failure/Transplant Program of St. Louis Children's Hospital, and professor of pediatrics, Washington University School of Medicine.
The events of the day culminated in the public forum vote by the panel on the questions of Excor device safety and probable benefit. The panel members voted unanimously in favor of HDE approval.
The following U.S. centers participated in the IDE study:
- Arkansas Children's Hospital (Ark.)
- Boston Children's Hospital (Mass.)
- Children's Healthcare of Atlanta (Ga.)
- Children's Hospital of Wisconsin (Wis.)
- The Children's Hospital of Denver (Colo.)
- Lucille Packard Children's Hospital at Stanford (Calif.)
- Mott Children's Hospital (Mich.)
- Mount Sinai Hospital (N.Y.)
- Pittsburgh Children's Hospital (Penn.)
- Riley Children's Hospital (Ind.)
- Seattle Children's Hospital (Wash.)
- St. Louis Children's Hospital (Mo.)
- Texas Children's Hospital (Texas)
- Children's Hospital at the University of Alabama (Ala.)
- University of Minnesota at Fairview (Minn.)
While Berlin Heart awaits the final decision of the FDA, implants of the Berlin Heart Excor pediatric VAD in the United States for bridge-to-transplant patients are continuing under a continued access protocol approved by the FDA.
For more information: www.berlinheart.com