Challenges in the Development and Evaluation of Pediatric Heart Valve Technologies.

Background: In October 2022, the Heart Valve Collaboratory and Food and Drug Administration convened a global multidisciplinary workshop to address the unmet clinical need to promote and accelerate the development of pediatric-specific heart valve technologies.

Methods: The Pediatric Heart Valve Global Multidisciplinary Workshop was convened in October 2022. Key stakeholders, including expert clinicians in pediatric cardiology and cardiac surgery, valve manufacturers, engineers and scientists were assembled to review the current state-of-the-art, discuss unique challenges in the pre-and post-market evaluation of pediatric valve therapies, and highlight emerging technologies that show potential to address some of the key unmet needs of children with valve disease.

Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By Doing for Children.

Background: The Harmonization By Doing (HBD) program was established in 2003 as a partnership among stakeholders of academia, industry and regulatory agencies in Japan and the United States, with a primary focus on streamlining processes of global medical device development for cardiovascular medical devices. While HBD has traditionally focused on development of devices intended to treat conditions prevalent in adults, in 2016, HBD established the "HBD-for-Children" program, which focuses on the development of pediatric devices as the development of medical devices for pediatric use lags behind that of medical devices for adults in both countries.

Methods and results: Activities of the program have included: (1) conducting a survey with industry to better understand the challenges that constrain the development of pediatric medical devices; (2) categorizing pediatric medical devices into five categories based on global availability and exploring concrete solutions for the early application and regulatory approval in both geographies; and (3) facilitating global clinical trials of pediatric medical devices in both countries.

Regulatory Science, and How Device Regulation Will Shape Our Future.

Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization.

Decision analysis of retrievable inferior vena cava filters in patients without pulmonary embolism.

Background: Retrievable filters are increasingly implanted for prophylaxis in patients without pulmonary embolism (PE) but who may be at transient risk. These devices are often not removed after the risk of PE has diminished. This study employs decision analysis to weigh the risks and benefits of retrievable filter use as a function of the filter's time in situ.

Influence of age and fall type on head injuries in infants and toddlers.

Unlabelled: Age-based differences in fall type and neuroanatomy in infants and toddlers may affect clinical presentations and injury patterns.

Objective: Our goal is to understand the influence of fall type and age on injuries to help guide clinical evaluation.

Design/setting/participants: Retrospectively, 285 children 0-48 months with accidental head injury from a fall and brain imaging between 2000 and 2006 were categorized by age (infant ≤1 year and toddler=1-4 years) and fall type: low (≤3 ft), intermediate (>3 and <10 ft), high height falls (≥10 ft) and stair falls.

Biomechanics of the toddler head during low-height falls: an anthropomorphic dummy analysis.

Object: Falls are the most common environmental setting for closed head injuries in children between 2 and 4 years of age. The authors previously found that toddlers had fewer skull fractures and scalp/facial soft-tissue injuries, and more frequent altered mental status than infants for the same low-height falls (
Methods: To identify potential age-dependent mechanical load factors that may be responsible for these clinical findings, the authors created an instrumented dummy representing an 18-month-old child using published toddler anthropometry and mechanical properties of the skull and neck, and they measured peak angular acceleration during low-height falls (1, 2, and 3 ft) onto carpet pad and concrete.

Physiological and pathological responses to head rotations in toddler piglets.

Closed head injury is the leading cause of death in children less than 4 years of age, and is thought to be caused in part by rotational inertial motion of the brain. Injury patterns associated with inertial rotations are not well understood in the pediatric population. To characterize the physiological and pathological responses of the immature brain to inertial forces and their relationship to neurological development, toddler-age (4-week-old) piglets were subjected to a single non-impact head rotation at either low (31.

In situ deformations in the immature brain during rapid rotations.

Head trauma is the leading cause of death and debilitating injury in children. Computational models are important tools used to understand head injury mechanisms but they must be validated with experimental data. In this communication we present in situ measurements of brain deformation during rapid, nonimpact head rotation in juvenile pigs of different ages.