DePuy Synthes Trauma announced today the U.S. launch of CONFORM® Flex with Q-PACK® Technology, the only pre-hydrated demineralized cancellous bone tissue matrix designed for use in trauma-related extremity procedures (foot and ankle, hand and wrist), including fusion, and for filling bone voids. The announcement was made here at the 2015 Orthopaedic Trauma Association (OTA) Annual Meeting.
The new biologic implant, which is available in cube and strip configurations, is both osteoconductive (provides a natural scaffold for new bone growth) and osteoinductive (stimulates new bone formation). It resists migration after implantation, readily absorbs and retains bone aspirate, blood and saline, and can be osteogenic (accelerates bone growth) when combined with bone marrow aspirate. The implant is also highly flexible and may be compressed up to 50 percent of its original size.
CONFORM Flex is offered with Q-PACK Technology, an ambient temperature packaging method that enables the tissue form to come in a fully hydrated state, eliminating the rehydration step required in procedures using other implants of this kind. The tissue form is ready for use immediately out of the package.
“What I appreciated about CONFORM Flex was the ease of use and its ability to conform easily in the joints that I had prepared for fusion,” said Stephen Carley, MD, Mary Washington Hospital in Fredericksburg, Virginia. “I was especially impressed by the way it maintained its position and integrity during positioning and compression of the fusion sites with internal fixation.”
CONFORM Flex is processed by the Musculoskeletal Transplant Foundation (MTF), resulting in tissue quality and safety through their approach to donor selection and allograft processing. During processing, the natural growth factors that provide CONFORM Flex with its osteoconductive properties and conformability are exposed, and pH is restored to a normal physiologic range allowing optimal cell viability and function. Processing and packaging are performed under controlled aseptic condition. ISO Class 4 certified clean rooms are used to ensure the finished tissue form passes USP <71> sterility tests.