Archive for March, 2008

Medtronic hails release of fracture risk tool by WHO

Medtronic logoMedtronic Inc. has hailed the World Health Organization (WHO) for releasing a fracture risk tool. The 10-year fracture risk model FRAX™ is clinically based and has been developed by WHO and Dr. John A. Kanis, professor emeritus at the University of Sheffield in the U.K. The tool places patients with a prior record of clinical spinal fracture under the high risk category.

VertiFlex gets FDA clearance for Silverbolt

SilverboltVertiFlex Inc. has announced receiving 510K clearance from the FDA for the Silverbolt™ Percutaneous Multi-Level Rod (MLR) System. The system delivers two rods in one screw for multi-level spine stabilization applications. The Silverbolt MLR System offers an alternative to other more invasive approaches that cause more blood loss and late patient recovery by percutaneously stabilizing multiple vertebral levels of the spine.

MRI, CT more sensitive in detecting bone erosions

Magnetic resonance imaging (MRI) and computed tomography (CT) produce better detection of bone erosion in rheumatoid arthritis (RA) than radiography, according to research published in Arthritis Research & Therapy. The early detection of bone erosion is very important in the treatment of patients with rheumatoid arthritis. Dr Møller Døhn of the Copenhagen University Hospital said, “The number of erosions detected on CT indicate that CT is a very sensitive method for detecting bone erosions in RA wrist bones, possibly even more sensitive than MRI.”

Osteotech gets FDA nod for Plexur M(TM) Biocomposite

Plexxur BiocompositeOsteotech Inc. has received FDA approval for its 510(k) submission for its Plexur M(TM) Biocomposite. Plexur M is intended for use in filling bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. During the healing process, Plexur M is remodeled and replaced by host bone. When heated, Plexur M becomes moldable and pliable, which allows surgeons various options for use during surgery. During the cooling process, Plexur M hardens, providing a versatile porous scaffold to help in regeneration of damaged and diseased bones.

Osteotech’s president and CEO Sam Owusu-Akyaw has indicated that the company intends to file an additional submission for the use of this product in spinal applications during the second quarter of the year.

New rheumatoid arthritis drug to treat IL6 secretion

Bone Medical LogoThe latest data from Bone Medical’s rheumatoid arthritis (RA) program indicates that BN006 is capable of inhibiting secretion of IL6. The lead drug candidate has been developed to inhibit the secretion of TNF, which is a cytokine associated with the inflammatory process that perpetuates RA. BN006 is now also found to inhibit IL6 secretion by macrophage type cells in culture with a clear dose-response relationship. IL6 is one of the important targets in new therapeutics for the treatment of RA.