RTI Surgical announces that the U.S. FDA has granted Investigational Device Exemption approval for a clinical study designed to confirm the safety and effectiveness of Cortiva Allograft Dermis in implant-based breast reconstruction.
Processed using the TutoplastTissue Sterilization Process, Cortiva Allograft Dermis implants are currently regulated as Section 361 human cell and tissue products and restricted to homologous use for the repair, replacement, reconstruction, or augmentation of soft tissue.
Olivier Visa, president and CEO of RTI Surgical, emphasizes the company’s commitment to advancing patient care by providing human acellular dermal matrix for individuals undergoing breast reconstruction as part of their breast cancer treatment.
“This milestone marks a significant step toward obtaining FDA pre-market approval (PMA) for our Cortivaallograft implants,” Visa says. “It reinforces our strategic objective of becoming a leading medical device company in regenerative medicine by offering a diverse portfolio that enables surgeons to better address the unique needs of their patients.”
In consultation with the FDA, RTI Surgical developed a comprehensive clinical study to support its PMA application to obtain an indication for use in breast reconstruction. Patient enrollment is scheduled to begin in the first half of 2024 at various sites across the United States.