The Food and Drug Administration (FDA) has recently granted RTI Surgical Inc. Investigational Device Exemption (IDE) approval for a clinical study of Cortiva® Allograft Dermis in breast reconstruction. This approval marks a significant milestone in the development of innovative solutions for breast reconstruction procedures.
Breast reconstruction is a surgical procedure performed to restore the shape, size, and appearance of a breast after a mastectomy or lumpectomy. It is an essential part of the overall treatment plan for many women who have undergone breast cancer surgery. Traditionally, breast reconstruction has been performed using autologous tissue or implants. However, these methods have their limitations and may not always provide satisfactory results.
RTI Surgical Inc., a leading global surgical implant company, has developed Cortiva® Allograft Dermis as an alternative solution for breast reconstruction. Allograft dermis is a human tissue graft derived from donated cadaveric skin. It undergoes a rigorous screening and processing procedure to ensure safety and efficacy.
The IDE approval granted by the FDA allows RTI Surgical Inc. to conduct a clinical study to evaluate the safety and effectiveness of Cortiva® Allograft Dermis in breast reconstruction procedures. The study will involve a group of patients who will undergo breast reconstruction using Cortiva® Allograft Dermis and will be closely monitored for any adverse events or complications.
The use of allograft dermis in breast reconstruction offers several potential advantages over traditional methods. Firstly, it eliminates the need for additional surgery to harvest autologous tissue from another part of the body, reducing surgical time and potential donor site complications. Secondly, allograft dermis provides a scaffold for the patient’s own cells to grow and integrate, resulting in a more natural-looking and feeling reconstructed breast.
Moreover, Cortiva® Allograft Dermis has been shown to have excellent handling characteristics, making it easy for surgeons to shape and position during the reconstruction procedure. It also has a low risk of infection and rejection, as it undergoes a thorough sterilization process and is processed to remove immunogenic components.
The clinical study will provide valuable data on the safety and effectiveness of Cortiva® Allograft Dermis in breast reconstruction. If successful, it could potentially revolutionize the field of breast reconstruction by offering a viable alternative to autologous tissue and implants.
Dr. Camille Cash, a board-certified plastic surgeon, expressed her enthusiasm about the FDA’s approval, stating, “The IDE approval for the clinical study of Cortiva® Allograft Dermis in breast reconstruction is a significant step forward in providing women with more options for achieving natural-looking and feeling breasts after mastectomy. This innovative approach has the potential to improve patient outcomes and satisfaction.”
Breast cancer survivors who are considering breast reconstruction should consult with their healthcare providers to determine if they are eligible to participate in the clinical study. The results of this study will contribute to the growing body of evidence supporting the use of allograft dermis in breast reconstruction and may pave the way for its widespread adoption in the future.
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