RTI Surgical Initiates ADMIRE Study for Cortiva Allograft Dermis in Breast Reconstruction
核心洞察
RTI Surgical has enrolled the first patient in the ADMIRE study to evaluate Cortiva Allograft Dermis (搜索) for implant-based breast reconstruction.
The ADMIRE study is a prospective, multi-center, dual-arm, non-randomized clinical trial involving 467 female patients undergoing two-stage breast reconstruction.
Cortiva ADM, processed with RTI’s Tutoplast Tissue Sterilization Process, is being investigated for its safety and effectiveness in pre-pectoral breast reconstruction.
RTI Surgical has announced the enrollment of the first patient in the ADMIRE (Acellular Dermal Matrix Investigation in Breast Reconstruction) study. This Investigational Device Exemption (IDE) study is designed to evaluate the safety and effectiveness of Cortiva Allograft Dermis (搜索) (ADM) in implant-based breast reconstruction. The study is a significant step towards providing clinically validated options for surgeons and patients undergoing breast reconstruction as part of breast cancer (搜索) treatment.
Cortiva ADM is a graft derived from human dermis and processed using RTI’s proprietary Tutoplast Tissue Sterilization Process. It is commonly used in soft tissue repair. The ADMIRE study is a prospective, multi-center, dual-arm, non-randomized clinical study that will enroll 467 female patients undergoing two-stage breast reconstruction using the pre-pectoral technique. The study protocol was developed with advice and input from the FDA.
Study Design and Objectives
The ADMIRE study is designed to support RTI’s pre-market approval application for a breast reconstruction indication. The primary objective is to confirm the safety and effectiveness of Cortiva ADM in this specific application. The study's dual-arm, non-randomized design allows for a comprehensive evaluation of the allograft dermis in a real-world clinical setting.
Expert Perspectives
Amanda LoGuidice PhD, Chief Scientific Officer of RTI Surgical, stated, "Our goal is to provide surgeons and patients with clinically validated options that meet the individual needs of those undergoing breast reconstruction as part of breast cancer (搜索) treatment. This study, the first allograft IDE in this field, underscores our commitment to advancing patient care through innovative, evidence-based solutions. We are eager to progress through this trial and deliver solutions that we believe will improve outcomes for patients."
Dr. Suhail A. Kanchwala, National Principal Investigator for the study and Associate Professor of Surgery at the University of Pennsylvania, added, "I am excited to lead this important clinical trial as the National Principal Investigator. This study represents a significant step forward in advancing patient care...our collaborative efforts will generate meaningful data that can shape the future of breast reconstruction and, hopefully, will set new standards in improving patient outcomes and quality of life."
About RTI Surgical
RTI Surgical (RTI) is a leading Contract Development and Manufacturing Organization (CDMO) focused on innovation and tissue engineering in regenerative medicine. They partner with Original Equipment Manufacturers (OEMs) to develop customized solutions that promote healing, accelerate recovery, and help prevent complications. RTI's portfolio of biological materials is used in plastic and reconstructive surgery, sports medicine and orthopedics, cardiac, and neuro and spine surgery.