Cellmyx, which offers autologous adipose grafting and transfer products, announces that the U.S. FDA has granted 510(k) clearance for intelliFat® BOD™, a single-use kit for macro, micro, and nano fat tissue harvesting, processing, and transfer. Specifically, intelliFat BOD uses a patient’s own body fat, clinically referred to as adipose tissue, to aid in patient recovery and healing.
Moreover, intelliFat BOD preserves cellular and tissue micro-architecture of adipose, eliminating residual oil emulsion and blood, thereby providing a tissue byproduct that is minimally manipulated in accordance with FDA guidelines for human cell and tissue products. Kits are sterile, disposable, and contain components to harvest, process, and transfer autologous adipose tissue for use as an alternative, and/or as an adjunct, to surgery for filling soft-tissue defects and promoting healing in plastic and cosmetic surgery, among other procedures.
Physicians feel empowered, according to Cellmyx officials. They have the assets they need right to perform this procedure without incising, stitching, or scarring the patient. intelliFat BOD streamlines procedure times to under 30 minutes with its harvesting, processing, and transfer system. Patients experience no discomfort or downtime during or post-procedure and may return to normal social activities immediately with clearance from their provider, Cellmyx officials add.
The intelliFat® 510(k) specifically includes procedures for plastic, cosmetic, and reconstructive surgery.