Soft Tissue Defect Void Filler
Supports Soft Tissue Where Weakness Exists
Volumetric muscle loss (VML) refers to a muscle injury so severe that it exceeds the body’s natural capacity to repair the muscle deficit. Soft tissue injuries such as VML occur in military and civilian settings, due to trauma (e.g., blast injuries on the battlefield or automobile accidents). These injuries can also occur as part of a surgical procedure or from a variety of congenital and acquired conditions. VML injuries often result in permanent loss of muscle function and unsightly cosmetic disfigurement, both of which can negatively affect Wounded Warrior and patient self-esteem and quality of life. Current therapeutic options are limited, and new strategies are necessary for effective management of soft tissue injuries like VML.KeraNetics™, in collaboration with experts in the field of regenerative medicine, is developing a product that will provide a solution for VML and other soft tissue injuries in Wounded Warriors and civilian trauma patients, among others. This product is called KeraGenics® Muscle and is indicated for use to temporarily address volume deficits in soft tissue injuries. By providing a void filler to address the volume deficit, the window for more aggressive (or advanced) therapeutic intervention may be increased, which can be particularly important in times of war when evacuation from lower echelons of trauma care is uncertain. Intended users include trauma, orthopaedic, and plastic / reconstructive surgeons who treat patients presenting with muscle or soft tissue defects. KeraGenics® Muscle should not be used in injuries where voids exceed 20% (or a maximum of 25 mL) of a given tissue or where suture of the product is required. This product will be restricted to use by order of a physician.