A new pain management therapy has been cleared for use in adolescents thanks to a groundbreaking collaboration between the UCSF-Stanford Pediatric Device Consortium (PDC), AtriCure, Inc., and the U.S. Food and Drug Administration (FDA).

On January 4th, AtriCure announced that the FDA cleared its cryo nerve block (cryoNB) devices cryoICE ® and cryoSPHERE™ for post-operative pain management in patients aged 12 and above. The expanded claims were allowed based on real-world evidence (RWE) developed by researchers at the PDC. RWE is an emerging area of regulatory science where evidence derived from real-world data (captured outside of traditional clinical trial settings) is used to evaluate the potential risks and benefits of a device or drug and inform regulatory decision making.

A research team including UCSF pediatric surgeons Dr. Olajire Idowu and Dr. Sunghoon Kim has been awarded a grant to support commercialization of the "Prolapse Whisperer", a novel medical device to treat and prevent recurrent stomal prolapse. Stomal prolapse occurs when the bowel near the stoma, a surgically created intestinal opening, intussuscepts from within causing possible bowel obstruction and ischemia (restriction in blood supply to tissues). Current treatments include manual reduction by force or a surgical procedure. Unfortunately, neither is durable and additional recurrences are common.