Pediatric and Congenital Electrophysiology Society Initiative on Device Needs in Pediatric Electrophysiology
The Heart Rhythm Society endorsed the document on October 12, 2018.
December 20, 2018—In the past 5 years, there have been several initiatives in pediatric cardiology, specifically in the heart failure and interventional cardiology domains, to develop and market devices that have been designed for the pediatric patient. PACES developed a task force in 2016 to specifically address comprehensive device development issues for the pediatric/congenital heart disease arrhythmia patient, ranging from cardiovascular implantable electronic devices to ablation catheters.
In November 2016, a PACES task force, supported by the Heart Rhythm Society, met with representatives from the FDA Center for Devices and Radiologic Health (CDRH) to discuss the present state of medical device technology as it relates to the needs in the congenital electrophysiology area. FDA leadership confirmed the intention of the FDA to work with all stakeholders, including academia and industry, to support development in the pediatric medical device ecosystem. The PACES task force clarified priority medical device development opportunities (outlined below) aimed at enhancing care options for children with arrhythmias.
In May 2017, members of the PACES task force, FDA, and industry met to discuss these issues and to share expertise in pediatric needs, development challenges, and regulatory requirements. This document reviews those issues, including specific pediatric needs and existing obstacles to development of pediatric-specific technology, and identifies opportunities to address these issues.