ArthroCare Corp. announced that it has received clearance from the FDA to market its Parallax® Contour® Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures. The newly cleared Indication Statement provides that the Contour device is indicated for use during kyphoplasty or vertebral augmentation procedures.

Read the full story here

Pfizer Inc. has announced the suspension of the osteoarthritis clinical program for the investigational compound tanezumab following a request by the U.S. Food and Drug Administration (FDA). The worldwide suspension which is effective immediately follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab.

Read the full story here

Prolia, a new injectable drug to treat osteoporosis in postmenopausal women at high risk of fractures has been approved by the US Food and Drug Administration (FDA).The federal agency has announced that approving Prolia, made by Amgen, offers postmenopausal women with osteoporosis at high risk of fractures another treatment option. Osteoporosis is a disease that weakens bone and makes it more likely to break.

Read the full story here

Stryker announced that it has been declared in compliance with FDA manufacturing standards and has satisfied issues raised in a 2007 warning letter over quality issues in its reconstructive implant factory that manufactured the Stryker Trident hip implant in New Jersey.

The warning in 2007 found that quality control failures contributed to problems with the implants, including the presence of staph infections causing bacteria and other quality control issues. The issues included reports of patients who continued to experience discomfort and pain after hip replacement surgery, improper wear of the hip implants and squeaking.

The company still has 2  outstanding warnings from FDA over manufacturing in Ireland or how the company sterilized its discontinued cranial implant kits.

Stryker is one of the world’s largest medical devices companies operating in the global orthopedic market.

The FDA has approved the drug to treat rheumatoid arthritis, Actemra, the only product on the market that will actively prevent this inflammatory process at the source. Although there are 9 biologically designed products on the market that will treat certain forms of arthritis, Actemra is the only drug that is targeting the disease at the molecular level.

Actemra prevent the arthritis by effectively halting the processing ability of a specific molecular protein known as Interleukin 6 which is known to cause inflammation in the bones and joints of the human body.

A recent study, conducted by researchers at University of Rochester Medical Center and presented at the annual meeting of the American Society for Bone and Mineral Research in Denver, indicated that a drug already approved to heal bone loss from osteoporosis may also help to prevent and reverse the damage to cartilage that leads to osteoarthritis. Currently, there are no drugs to treat cartilage loss in osteoarthritis, a condition that’s expected to affect some 50 million Americans by 2020. Parathyroid hormone, sold as the prescription drug teriparatide (Forteo), is already approved by the FDA to maintain and heal bone, and earlier studies have suggested that it also affects cartilage cells.

The FDA has approved Austin surgical device maker LDR’s ROI-C cervical cage. This product helps in standalone cervical fusion surgeries, making it less necessary to use thick cervical plates that contribute to dysphagia or difficulty swallowing. LDR CEO Christophe Lavigne said “The entry of the ROI-C cervical cage into the U.S. market represents a huge step for us in continuing to provide innovative, surgeon-friendly solutions for varied spinal pathologies.”

Drug maker Bristol-Myers Squibb has received the FDA approval for a broader labeling of its rheumatoid arthritis drug, Orencia. Orencia can now also be used to treat patients with moderate-to-severe rheumatoid arthritis of less than or equal to two years duration. Orencia was initially approved for the treatment of moderate-to-severe rheumatoid arthritis patients who did not respond to other drugs.

MAKO Surgical Corp. has announced that it received two 510(k) clearances from the US Food and Drug Administration to market both the Company’s proprietary Version 2.0 Tactile Guidance System(tm) (TGS(tm)), branded as the MAKO RIO(tm), and its bicompartmental knee resurfacing implant system, branded as RESTORIS(r) MCK. MAKO currently expects to commercially launch both the RIO(tm) system and the RESTORIS(r) MCK system in the first half of 2009. Obtaining the FDA 510(k) clearance for each of these products represents the achievement of a key milestone towards the continuing commercialization of innovative technology that restores patient quality of life.

Biospace med has announced that data from a clinical study of its FDA-cleared ‘EOS’ 3D x-ray orthopedic imaging system conducted by a Montreal-based hospital-”EOS: A New Breed of X-Ray Imager Using Low-Dose Slot-Scanning to Achieve High-Quality Images”-showed that the EOS ultra-low-dose orthopedic imaging system makes possible “better image quality” than CR imaging while using nearly 10 times less radiation.” EOS is designed to capture head-to-toe images of patients in a standing, weight-bearing position while reducing up to 90% of the radiation dose compared to a conventional x-ray and up to 1000 times less radiation than a conventional CT scan.