Sam Brusco, Associate Editor11.27.23
RTI Surgical has been granted investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) for a clinical study of its Cortiva allograft dermis in implant-based breast reconstruction.
Processed using RTI’s Tutoplast tissue sterilization, Cortiva are regulated as Section 361 human cell and tissue products (HCT/Ps) and restricted to homologous use for soft tissue repair, replacement, reconstruction, or augmentation.
The company emphasized human acellular dermal matrix (ADM)’s use for those undergoing breast reconstruction as a part of their breast cancer treatment.
"This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva allograft implants,” RTI’s president and CEO Olivier Visa told the press. “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."
Consulting with the FDA, RTI said it developed a comprehensive clinical study to support its premarket approval (PMA) application to gain an indication for breast reconstruction. The company said that patient enrollment in the study is expected to start in the first half of 2024 at a number of sites across the U.S.
Headquartered in Alachua, Fla., RTI develops and delivers surgical implants across the dental, plastic & reconstructive surgery, sports medicine, spine, trauma, and urology/urogynecology specialties.
Processed using RTI’s Tutoplast tissue sterilization, Cortiva are regulated as Section 361 human cell and tissue products (HCT/Ps) and restricted to homologous use for soft tissue repair, replacement, reconstruction, or augmentation.
The company emphasized human acellular dermal matrix (ADM)’s use for those undergoing breast reconstruction as a part of their breast cancer treatment.
"This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva allograft implants,” RTI’s president and CEO Olivier Visa told the press. “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."
Consulting with the FDA, RTI said it developed a comprehensive clinical study to support its premarket approval (PMA) application to gain an indication for breast reconstruction. The company said that patient enrollment in the study is expected to start in the first half of 2024 at a number of sites across the U.S.
Headquartered in Alachua, Fla., RTI develops and delivers surgical implants across the dental, plastic & reconstructive surgery, sports medicine, spine, trauma, and urology/urogynecology specialties.