RAYNHAM, MA, 04/28/2009 — DePuy Spine, Inc. announced the launch of HEALOS® Fx Injectable Bone Graft Replacement (HEALOS® Fx), the company's first bone graft solution designed specifically for minimally invasive spine surgery (MIS). HEALOS® Fx is a moldable, injectable version of HEALOS® Bone Graft Replacement, which is the company's osteoconductive and osteogenic (when combined with bone marrow aspirate) bone graft substitute which has been shown to achieve fusion rates equivalent to autograft in peer-reviewed, published human clinical studies.(1),(2)
HEALOS® Fx is a ready-to-use fibrous material that can be molded for open applications or injected via cannulas of differing lengths to reach difficult implantation sites in minimally invasive or small void surgical environments. The original form of HEALOS, which exists as pre-formed strips of varying sizes, has been available for more than seven years in the U.S. and has been used in more than 65,000 procedures nationwide.
The new HEALOS® Fx is a bone graft option for precise placement into difficult-to-reach surgical sites, particularly around pedicle screws and the interbody space, said Kornelis Poelstra, M.D., Ph.D., University of Maryland Shock Trauma, Baltimore. In addition, since the chemical composition of HEALOS and HEALOS® Fx is identical, the compelling safety and performance records of the graft material have been well established."
HEALOS Fx, which has a cohesive consistency when saturated with the patient's bone marrow, provides both a continuous scaffold for bone formation and the osteoprogenitor cells needed to initiate new bone growth. The material is resorbed and remodeled into new bone as part of the healing process. HEALOS® Fx was designed using proprietary DePuy Spine nanotechnology which promotes osteoprogenitor cell attachment and maturation. HEALOS® Fx comes with a self-contained mixing and delivery device that allows for a smooth, simple mixing motion to create a uniform graft material in less than one minute.
HEALOS is a proven technology platform that we are now able to offer in a new form to provide surgeons greater versatility, particularly when performing MIS procedures," said Ian Burgess, Worldwide VP of Research and Development for DePuy Spine.
HEALOS® Fx is compatible with DePuy Spine's minimally invasive VIPER2 Pedicle Screw Fixation System and can also be used with the LifeNet Health® VERTIGRAFT® portfolio of interbody spacers. HEALOS® FxInjectable Bone Graft Replacement, combined with autogenous bone marrow, is intended for use in filling bony voids or gaps of the skeletal system (i.e., the extremities, spine, and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone.
1 Khoueir, P; Oh, BC; DiRisio, DJ; Wang, MY. "Multilevel Anterior Cervical Fusion Using a Collagen-Hydroxyapatite Matrix with Iliac Crest Bone Marrow Aspirate: An 18-Month Follow-up Study." Neurosurgery 2007;61(5):963-971.
2 Kitchel S. "A Preliminary Comparative Study of Radiographic Results Using Mineralized Collagen and Bone Marrow Aspirate vs. Autologous Bone in the Same Patients Undergoing Posterior Lumbar Interbody Fusion with Instrumented Posterolateral Lumbar Fusion." The Spine Journal 2006;6(4):405-412.
About DePuy Spine, Inc.
DePuy Spine, Inc. is an operating company of DePuy, Inc., a Johnson & Johnson company, one of the world's leading designers, manufacturers, and suppliers of orthopaedic devices and supplies. We are known throughout the medical world for the development, manufacture, and marketing of innovative solutions of a wide range of spinal pathologies.