Lipogems announces new FDA clearance
In a recent press release, Lipogems, a leading international tissue repair company, today announced the U.S. Food and Drug Administration 510(k) clearance for expanded indications and labeling of The Lipogems® System for adipose tissue transfer.
Lipogems’ historical offering provides a single-use, disposable device which processes autologous adipose tissue for use as an alternative, and/or as an adjunct, to surgery for filling soft tissue defects and promoting healing in orthopaedics, plastic surgery, and a number of other surgical specialties.
Lipogems’ new FDA clearance better defines the indications as harvesting, concentrating and transferring of autologous adipose tissue, and expands the initial indications into the field of arthroscopy (i.e. minimally invasive surgery in joints). In addition, the updated FDA clearance defines that the Lipogems System preserves the cell and tissue micro-architecture of the adipose tissue, eliminates residues of oil emulsion and blood, and provides a tissue that is minimally manipulated in accordance with FDA guidelines for Human Cell and Tissue Products.