Meghan Grimaldi (508)828-3246
FOR IMMEDIATE RELEASE
DEPUY SYNTHES TRAUMA LAUNCHES NEW BIOLOGIC IMPLANT ® TO AID HEALING AND FORMATION OF NEW BONE IN TRAUMA SURGERY
New CONFORM® FLEX Only Pre-Hydrated Biologic for Trauma-Related Extremity Procedures
San Diego, CA – October 8, 2015 -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 osteoconductive¹ (provides a natural scaffold for new bone growth) and osteoinductive²,³ (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.4 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 theMusculoskeletal 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.
About DePuy Synthes Companies
DePuy Synthes Companies of Johnson & Johnson provides the most comprehensive orthopaedic and neurological solutions in the world. The company offers an unparalleled breadth of products, services, programs and research and development capabilities. DePuy Synthes Companies’ solutions in the specialties of joint reconstruction, trauma, neurological, craniomaxillofacial, spinal surgery and sports medicine are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information visit, www.depuysynthes.com .
*A division of DePuy Orthopaedics, Inc.
**CONFORM Flex is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product); pursuant to 21 CFR 1271.
CONFORM and Q-PACK are registered trademarks of the Musculoskeletal Transplant Foundation.
©DePuy Synthes 2015. All rights reserved.
¹ CONFORM with Q-PACK®: An Evaluation of a Pre-Hydrated Fully Demineralized Cancellous Scaffold Seeded with Human Mesenchymal Cells (white paper); Musculoskeletal Transplant Foundation 2011. (00014CI)
² Data on file at MTF
³ M. Urist, “Bone Formation by Autoinduction.” Science, 1965; 150: 893-899.
4 Mclain R., Fleming J., Boehm C., Muschler G. Aspiration of Osteoprogenitor Cells for Augmenting Spinal Fusion: Comparison of Progenitor Cell Concentration from the Vetebral Body and Iliac Crest. J Bone Joint Surg. 2005; 2655-2661.