RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction

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ALACHUA, Fla., Nov. 27, 2023 /PRNewswire/ -- RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis in implant-based breast reconstruction.

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Provider:

PR Newswire

Retrieved on:

Monday, November 27, 2023

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Tags:

ADM, RTI Surgical, Safety, RTI, Food, Surgeon, Breast cancer, Patient, Regenerative medicine, FDA, IDE, Trial of the century, Breast reconstruction, Investigational device exemption, PMA, Health, Dermis, Medical imaging

Geotags:

FLORIDA, UNITED STATES

Organisation:

RTI SURGICAL

Summary

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ALACHUA, Fla., Nov. 27, 2023 /PRNewswire/ -- RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva® Allograft Dermis in implant-based breast reconstruction.
Olivier Visa, President and Chief Executive Officer of RTI Surgical, emphasized the company's commitment to advancing patient care by providing human acellular dermal matrix (ADM) for individuals undergoing breast reconstruction as part of their breast cancer treatment.
"This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva® allograft implants.
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.

RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva® Allograft Dermis in Breast Reconstruction

ALACHUA, Fla., Nov. 27, 2023 /PRNewswire/ -- RTI Surgical, a leading global medical device organization, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for a clinical study designed to confirm the safety and effectiveness of Cortiva^® Allograft Dermis in implant-based breast reconstruction. Processed using the proprietary Tutoplast^®Tissue Sterilization Process, Cortiva^® Allograft Dermis implants are currently regulated as Section 361 human cell and tissue products (HCT/Ps) and restricted to homologous use for the repair, replacement, reconstruction or augmentation of soft tissue.

Olivier Visa, President and Chief Executive Officer of RTI Surgical, emphasized the company's commitment to advancing patient care by providing human acellular dermal matrix (ADM) for individuals undergoing breast reconstruction as part of their breast cancer treatment. "This milestone marks a significant step towards obtaining FDA pre-market approval (PMA) for our Cortiva^®allograft implants. 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.

This significant development underscores RTI Surgical's dedication to advancing medical innovation and elevating patient care.

About RTI Surgical
RTI Surgical (RTI) is an industry leading global medical device organization with expertise in HCT/P and medical device regulatory pathways. RTI partners with OEM customers to develop and deliver surgical implants across diverse market segments including Dental, Plastic & Reconstructive Surgery, Sports Medicine, Spine, Trauma and Urology/Urogynecology. RTI is headquartered in Alachua, Fla., and has manufacturing facilities in the United States and Europe. The company is accredited in the U.S. by the American Association of Tissue Banks. For more information, visit www.rtisurgical.com.

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SOURCE RTI Surgical