Tuesday, November 28, 2023
RTI Surgical has received the green light from the U.S. Food and Drug Administration (FDA) to conduct a clinical study involving Cortiva® Allograft Dermis for implant-based breast reconstruction. This approval enables the company to investigate the safety and effectiveness of Cortiva® Allograft Dermis specifically in this area.
Cortiva® Allograft Dermis implants, processed using the Tutoplast® Tissue Sterilization Process, fall under Section 361 human cell and tissue products (HCT/Ps). Presently, their use is limited to repair, replacement, reconstruction, or augmentation of soft tissue.
The FDA's approval of the Investigational Device Exemption (IDE) is a crucial milestone for RTI Surgical. It represents a significant step toward obtaining FDA pre-market approval (PMA) for Cortiva® allograft implants. RTI Surgical aims to establish itself as a prominent medical device company in regenerative medicine, offering a diverse portfolio to address patients' unique needs, especially in breast reconstruction.
To support its PMA application and gain approval for Cortiva® Allograft Dermis in breast reconstruction, RTI Surgical has developed a comprehensive clinical study. Scheduled to begin enrolling patients in the first half of 2024 across multiple U.S. sites, this study demonstrates the company's commitment to ensuring the safety and effectiveness of its product.
This development underscores RTI Surgical's strategic goals and dedication to advancing medical devices in regenerative medicine, emphasizing solutions tailored to meet the requirements of surgeons and their patients.
Source: prnewswire.com
