Core Insights - Johnson & Johnson MedTech has received FDA approval for an expanded indication of the TRUFILL n-BCA Liquid Embolic System for the embolization of the middle meningeal artery (MMA) to treat symptomatic subacute and chronic subdural hematoma (cSDH) as an adjunct to surgery [2][3] Group 1: Product and Approval Details - TRUFILL n-BCA has been a trusted solution in neurovascular embolization for over 25 years, originally approved in 2000 for treating arteriovenous malformations (AVMs) [4] - The approval is based on findings from the MEMBRANE randomized controlled trial, which showed TRUFILL n-BCA to be superior in effectiveness compared to the standard of care for embolization in MMA for treating symptomatic cSDH [3][4] - cSDH is often caused by minor head trauma, particularly in older adults and those on anticoagulation therapy, with recurrence rates estimated between 10% to 20% [2] Group 2: Clinical Significance - The MEMBRANE study demonstrated a positive treatment effect in favor of TRUFILL n-BCA, reinforcing its potential to improve outcomes for patients with cSDH [4][9] - The embolization of the MMA offers a minimally invasive endovascular approach, targeting smaller brain vessels that contribute to hematoma persistence and regrowth [2][3] Group 3: Industry Context - Johnson & Johnson MedTech is committed to addressing complex health challenges, including those related to neurovascular care, and aims to provide innovative technologies that improve patient outcomes [5][6] - The company is recognized as a global leader in various medical fields, including cardiovascular solutions, and is focused on tackling significant health issues such as heart failure and stroke [5][6]