The FDA and Pediatric Device Patients February 1, 2010

Devices and small children have always been a problematic combination.  As is the case for many therapies in children and congenital heart disease patients, we take therapies that are commonly used in adults and try to tailor them to our patients — with variable success. As would be expected, these technologies, are not designed for this population, and have limitations when employed in small patients. Large leads in small vessels, an inability to achieve high heart rates, inadequate coil spacing all complicate our use of pacemaker and ICD therapy.  I have been involved in many informal conversations as well as more organized forums where we have lamented the lack of interest/inability/lack of profitability of the device community in hearing and responding to the needs of our patients.

There may be a glimmer of hope. Congress has engaged drug companies in concentrating on pediatric issues by providing a 6-month extension on patents for drugs which have been tested in children. More recently, the Pediatric Medical Safety and Improvement Act has started to address the issues of lack of development of “pediatric-focused” products and lack of involvement of pediatric patients in clinical trials. The Pediatric EP community has been approached by the FDA to open a dialogue between pediatric electrophysiologists, and industry. Specifically, the FDA is looking for “easy fixes” for the device companies to tackle.

Please comment below with suggestions/thoughts.

Also, be sure to visit the Scientific Sessions online itinerary planner for category breakouts regarding devices and pediatric heart disease.