Archive for the 'General Orthopedics' Category

Ortho Kinematics Launches Multi-Site Clinical Study Of KineGraph VMA(TM)

Ortho KinematicsOrtho Kinematics has announced that it has begun a multi-site clinical study of the KineGraph VMA™, and that the initial 23 patients have been enrolled. The study will help determine which types of patients are best evaluated with KineGraph VMA testing. The KineGraph VMA is designed to provide functional diagnostic information to spine surgeons to be used in conjunction with MRI and plain X-rays.

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Winston Laboratories Receives Notice of Compliance for CIVANEX(TM) For Treatment Of Osteoarthritis

Winston LaboratoriesWinston Laboratories, Inc. has announced that it has received Notice of Compliance (NOC) from the Therapeutics Drug Directorate, Health Canada for its New Drug Submission (NDS) for CIVANEX ™ (zucapsaicin cream 0.075%) for the , treatment of the signs and symptoms of osteoarthritis. Since there is no systemic absorption of civamide, CIVANEX™ can be administered in combination with other systemic pain relief medications.

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High-Strain Tendons Repair Less Often

tendonIn a discovery that seems counterintuitive, a study appearing in the May 21st Journal of Biological Chemistry has found that tendons in high-stress and strain areas, like the Achilles tendon, actually repair themselves less frequently than low-stress tendons. This study sheds some light on the increased susceptibility of certain tendons to injury during aging. Tendons, composed of collagen and other proteins, serve to connect muscle to bone and thus are vital for movement.

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Stryker Trident Plant is FDA Compliant

strykerStryker 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.

TiGenix to acquire Orthomimetics

TiGenixTiGenix strengthens its product portfolio and biomaterials platform through the acquisition of Orthomimetics, a privately held medical technology company based in Cambridge, the United Kingdom. This acquisition fits with TiGenix’ growth strategy of becoming a leading player in the promising and fast-growing field of regenerative medicine. Orthomimetics’ flagship product, Chondromimetic™, is an off-the-shelf, resorbable implant for the minimally invasive repair of small osteochondral (cartilage and underlying bone) defects.

AlterG Develops Anti-Gravity Treadmill from NASA Technology

AlterGAlterG, Inc. has developed an anti-gravity treadmill using NASA technology that can provide users the feeling of moving about in less than 1 G. Anti-gravity treadmills. It is being sold under the name of Alter-G and is becoming common in hospitals, rehab centers, and sports facilities. Anti-G treadmills allow people to improve mobility and health, recover from injury and surgery more effectively, overcome medical challenges that limit movement, and enhance physical performance.

ACR: Tocilizumab Protects Joints Better than Methotrexate Alone

University of Pennsylvania School of MedicineUniversity of Pennsylvania School of Medicine researchers said that the investigational biologic agent tocilizumab appeared to prevent joint erosion among rheumatoid arthritis patients better than treatment with methotrexate alone. Over a two-year period, 75% of the people taking tocilizumab 4 mg/kg showed no radiographic progression or joint damage compared with 66% of patients taking methotrexate alone (P=0.0239).

Skylight Healthcare Systems Launches of iCarePassport(TM)

Skylight Healthcare SystemsSkylight Healthcare Systems launched iCarePassport, a breakthrough patient care and outcomes system for ongoing patient engagement that delivers hospitals the ability to provide personalized communication throughout the continuum of care. iCarePassport includes industry standard outcomes modules that patients can easily complete online which provide healthcare organizations information critical to monitoring and measuring evidence-based quality outcomes. iCarePassport provides surgeon-prescribed, diagnosis-specific, and personalized content that has flexible data gathering applications for patients and clinicians.

FDA to decide on Xiaflex shortly

AuxiliumAuxilium Pharma is awaiting a decision from the FDA on its key pipeline candidate, Xiaflex, for the treatment of Dupuytren’s Contracture. The drug has received favorable recommendation from the FDA’s Arthritis Advisory Committee. Dupuytren’s Contracture is a condition that affects the connective tissue in the palm known as palmar fascia. The company estimates that about 240,000 people suffer from Dupuytren’s in the US and the EU. This represents significant commercial opportunity for Auxilium.

Anika Therapeutics receive Canadian regulatory approval for Monovisc

MonoviscAnika Therapeutics Inc, a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, received approval from Canadian regulators to market Monovisc, an injected treatment for osteoarthritis (OA) of the knee. The product is already being marketed in the European Union (EU). Monovisc is the only single-injection visco-supplement approved for the relief of joint pain in all synovial joints.

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