Articles in the Bones / Orthopaedics Category
ETEX Corporation, an advanced biomaterials company, announced that the FDA has granted 510(k) clearance of CarriGen® Porous Bone Substitute Material. CarriGen is available for immediate sale through ETEX’s independent sales force. CarriGen builds upon the clinically proven benefit of ETEX nanocrystalline calcium phosphate technology by adding the advantage of increased porosity and pore size. CarriGen is the first highly porous bone graft substitute that sets hard upon implantation for a complete defect fill…
A research team led by Mayo Clinic has found a national trend toward younger, more diverse patients having total knee replacement surgery. The findings were presented today at the 2010 annual meeting of the American Academy of Orthopaedic Surgeons in New Orleans. Data from the Centers for Disease Control and Prevention’s National Hospital Discharge Survey were compared for 1990-1994 and 2002-2006 for patients having total knee replacements (also known as total knee arthroplasty). About 800,000 procedures were performed in 1990-1994, and 2.1 million in 2002-2006…
The ongoing wars in Iraq and Afghanistan have resulted in uniquely destructive patterns of combat injuries, including limb-threatening injuries to the knee. In the March special issue of Techniques in Knee Surgery military surgeons serving in Operation Iraqi Freedom and Operation Enduring Freedom share their experience with managing these high-energy injuries of the knee…
Heel pain is a very common foot problem. The sufferer usually feels pain either under the heel (planter fasciitis) or just behind it (Achilles tendinitis), where the Achilles tendon connects to the heel bone. Even though heel pain can be severe and sometimes disabling, it is rarely a health threat. Heel pain is typically mild and usually disappears on its own; however, in some cases the pain may persist and become chronic (long-term). There are 26 bones in the human foot, of which the heel (calcaneus) is the largest…
Porter Adventist Hospital is among the first in the country to receive designation as Blue Distinction Centers in two surgical services that have recently been added to the Blue Cross and Blue Shield Association’s expansion of its Blue Distinction® designation. Anthem Blue Cross and Blue Shield has designated Porter as a Blue Distinction Center for Spine SurgerySM and as a Blue Distinction Center for Knee and Hip ReplacementSM for demonstrating commitment to quality care in surgery and better overall outcomes for patients. St…
Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced that results from a clinical trial of Caldolor® (ibuprofen) Injection will be presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, Louisiana. A poster presentation of the study, entitled “A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in Post-Operative Orthopedic Adult Patients,” will be presented daily March 10 - 12 from 12:00 p.m. to 1:00 p.m. Neil Singla, M.D…
Following the recent announcement from Manchester-based Synexus that they had randomised 2,700 patients in just ten months for an osteoporosis study, the company has once again demonstrated that it is possible to recruit the agreed number of patients within the study deadline by recruiting 87% of patients to another study for the same therapeutic area. This trial, for a major biotech, involved eleven of Synexus’ twenty six dedicated recruitment centres across the UK, Europe and South Africa. There were nine US sites also taking part…
As many as half of all women and a quarter of men over the age of 50 can expect to sustain a fractured bone related to osteoporosis or low bone density. To enhance prevention and treatment of these fragility fractures, NewYork-Presbyterian Hospital/Columbia University Medical Center has implemented an innovative program called Own the Bone™ developed by the American Orthopaedic Association. “Research has shown that patients who have had a fragility fracture are four times more likely to experience another fracture than those who have never had a fracture…
Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has evaluated the content of the Company’s Complete Response submission for Prolia(TM) (denosumab) in the treatment of postmenopausal osteoporosis and classified it as a Class 2 resubmission. With the Class 2 designation, the FDA set a corresponding Prescription Drug User Fee Act (PDUFA) action date of July 25, 2010…
BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009…
