TransMedics Receives FDA IDE Approval to Initiate Next-Generation OCS Heart Trial

Core Insights - TransMedics Group, Inc. has received conditional approval from the FDA for its Investigational Device Exemption (IDE) to initiate the Next-Generation OCS ENHANCE Heart trial, which aims to transform organ transplant therapy for patients with end-stage organ failure [1][3] Group 1: Trial Details - The ENHANCE trial consists of two parts: Part A focuses on prolonged heart perfusion using the OCS™ Heart System, while Part B aims to demonstrate the superiority of OCS Heart perfusion in donation after brain death (DBD) cases compared to static cold storage methods [2] - The total sample size for the ENHANCE trial is expected to exceed 650 patients, potentially making it the largest heart preservation trial for transplant globally [2] Group 2: Company Overview - TransMedics is a leader in portable extracorporeal warm perfusion and assessment of donor organs for transplantation, headquartered in Andover, Massachusetts [4] - The company was founded to address the unmet need for better organ transplantation solutions and has developed technologies to preserve organ quality and assess organ viability prior to transplant [4]