Medical Device Network

FDA approves breast reconstruction trial using human ADM

The FDA has granted an IDE for a trial investigating the FlexHD in breast reconstruction, despite the agency previously implicating a higher risk profile for the device when used off-label.

The US Food and Drug Administration (FDA) has approved MTF Biologics’s trial using the FlexHD Pliable device in breast reconstruction after the agency granted an investigational device exemption (IDE).

The clinical study, which will launch in late next year, will evaluate the safety and effectiveness of the device for implant-based breast reconstruction.

The FlexHD Pliable is a human acellular dermal matrix (ADM). ADMs act as a scaffold for patient tissue to grow into and proliferate. The FDA has cleared some ADMs for use in hernia surgery, though the agency has not yet cleared or approved any of the implants for use in breast reconstruction.

MTF Biologics, a non-profit organisation headquartered in New Jersey, US, said it will enrol patients undergoing mastectomy and implant-based breast reconstruction across sites in the US. Data from the study will be used to support a pre-market approval application for the device for breast reconstruction.

ADMs have been extensively used off-label by surgeons in breast reconstruction surgery. The FDA has previously stated that, after conducting its own analysis, FlexHD and Becton Dickinson’s AlloMax may have higher risk profiles compared to other ADMs in this indication. The FDA did note limitations in its study including non-randomised design and different surgeon practices, and the companies do not currently endorse the implants' use in breast reconstruction.

The FDA’s IDE approval signifies the need for additional clinical data when assessing the benefits and risks of potentially approving the use of ADMs for this indication.

According to a 24 October statement by MTF Biologics, it is the first recipient of an IDE for a human acellular dermal matrix. In October 2022, The Plastic Surgery Foundation received an IDE for its acellular dermal matrix derived from non-human tissue – this trial involving an estimated 352 participants is currently ongoing (NCT05316324).

MTF Biologics CEO Joe Yaccarino said: "MTF Biologics is committed to ensuring the safety and efficacy of our tissues and dedicated to supporting plastic and reconstructive surgeons and the patients they care for each day. We look forward to beginning this important clinical study and advancing efforts to ensure that surgeons and patients have access to FlexHD Pliable.”

In April 2023, MTF Biologics launched an acellular human reticular dermal allograft to treat wounds such as diabetic foot ulcers and venous leg ulcers.