ATLANTA, Georgia - The U.S. Food and Drug Administration (FDA), Office of Cardiovascular Devices in the Center for Devices and Radiological Health (CDRH), is seeking 2 pediatric patients of varying ages and their caregivers and 1 young adult, to share their experience managing a cardiac condition due to congenital heart disease using a medical device. Examples include ventricular assist devices (VADs) that have helped provide a bridge to transplant for young patients; pacemakers and ICDs for treating life-threatening cardiac arrhythmias; or transcatheter pulmonary valves as an option to avoid open-heart surgery to help treat tetralogy of Fallot.
The patients and caregivers will participate in a panel discussion addressing topics such as what their experience has been using a medical device to manage their cardiac condition, what treatment options and risks they considered, and how they were informed about the treatment options and benefit/risk trade-offs of using the medical device. This event is for CDRH staff only, primarily for the Office of Cardiovascular Devices. The meeting has been tentatively planned for August 9th, 1:30 pm. – 3:30 pm. (EST).
In advance of the meeting, we will provide questions for the patients and caregivers that are likely to be asked. To help better understand pediatric patient needs, iCAN is seeking 2 young patient members and their caregivers and 1 young adult members who
are willing to share what it is like living with a cardiac medical condition, like heart valve or rhythm disorders
use a medical device for management of their condition, for example a pacemaker, defibrillator or ventricular assistive device (VADs)
may or may not have participated in a clinical trial using the medical device, and
would be open to sharing their personal experience for about 5-10 minutes and participate in the panel discussion.