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Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

The U.S. Food and Drug Administration has accepted for review the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron® Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer. Palliative treatment helps to relieve symptoms associated with advanced prostate cancer.

12 Mar 2010

2010 AAOS conference highlights ways to prevent orthopaedic traumas in children

Over the years, all terrain vehicles (ATVs) and motocross motorcycles have gained popularity and marketed as toys to consumers. These high-velocity machines can weigh between 300 and 600 pounds, and run on average between 25 and 60 miles per hour, while some even reach maximum speeds of 75 miles per hour.

11 Mar 2010

Cogent Healthcare, Seton Medical Center to develop exclusive hospitalist care delivery system

Cogent Healthcare today announced a new hospital medicine affiliation with 375-bed Seton Medical Center, located in Daly City, Calif., and the Daly City Hospitalist Medical Group, an existing Seton physician group, to develop a distinctive hospitalist care delivery system.

11 Mar 2010

HyperBranch Medical Technology's surgical sealants to be marketed under new name – Adherus Surgical Sealants

HyperBranch Medical Technology, Inc. announced today that it will begin to market their surgical sealants under a new product identity – Adherus Surgical Sealants.

11 Mar 2010

2010 AAOS meeting highlights advancements in back and spine treatment options

11 Mar 2010

$Advances in back care and treatment options for slipped disc, spine surgery and vertebral fractures$

Advances in back care and treatment options for slipped disc, spine surgery and vertebral fractures

Approximately 21 million visits were made to physicians' offices due to back problems in 2006. While countless adults experience back pain and stiffness, many suffer from serious spine and back conditions -including injury, herniated discs and the deterioration of the vertebrae. Three new studies presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) detail advances in back care and treatment options for specific back and spine conditions.

10 Mar 2010

ESWT applied with SANUWAVE’s Ossatron device results in 80% healing rate of nonunions of the tibia

SANUWAVE Health, Inc.,, an emerging medical technology company focused on the development and commercialization of non-invasive, biological response activating devices in the regenerative medicine area, today announced that a journal article titled Extracorporeal Shock Wave Therapy for Nonunion of the Tibia, was published in the March 2010 issue of the Journal of Orthopedic Trauma.

10 Mar 2010

Stryker's Orthopaedics division to feature two of its latest hip systems at AAOS conference

Stryker Corporation's Orthopaedics division announced today that it will feature two of its latest hip systems at this year's annual American Academy of Orthopaedic Surgeons conference being held in New Orleans – the Rejuvenate Modular Primary Hip System and the ADM Mobile Bearing Acetabular System with X3.

From Stryker 10 Mar 2010

Artificial periosteum heals serious bone injuries

A husband and wife research team has found a way to use the sleeve-like cover on bone to heal serious bone injuries faster and more simply than current methods. And they've developed an artificial sleeve that spurs fast healing when a car wreck, bomb blast or disease leaves too little cover.

10 Mar 2010

SMISS launches online series of CME-accredited education modules for spine surgeons

Since its founding in 2007, the Society for Minimally Invasive Spine Surgery (SMISS) has become the pre-eminent professional society for MIS surgeons. On March 1, 2010, the organization’s educational activities expanded dramatically with the launch of SMISS Highlights, an online series of CME-accredited education modules that are free of charge for spine surgeons.

10 Mar 2010

ETEX receives FDA marketing clearance for CarriGen Porous Bone Substitute Material

ETEX Corporation, an advanced biomaterials company, announced today 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.

9 Mar 2010

RepRegen's Strontium-based bioactive glass platform encourages osteoblast cell activity and proliferation

RepRegen™, the ‘smart biomaterials’ company previously known as BioCeramic Therapeutics, announced today that data from an in vitro study has demonstrated that its patented Strontium-based bioactive glass platform promotes osteoblast cell activity and proliferation. If in vivo studies, which are currently underway, demonstrate similar results, then RepRegen believes its platform has the potential to significantly improve the repair and regeneration of hard-tissue, such as bone.

9 Mar 2010

Comparative study reveals no clinical advantages of mobile bearing knee systems over fixed bearing knee systems

Stryker Corporation's Orthopaedics' division today announced at the American Academy of Orthopaedic Surgeons Conference that its recent FDA-monitored Investigational Device Exemption study found no statistical difference in clinical outcomes between its mobile bearing and traditional fixed bearing knee systems. In contrast, Stryker continues to be very pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers significant advantages over mobile bearing knees on wear rates and overall value.

9 Mar 2010

X-spine Systems, Gamma Spine announce exclusive agreement for minimally invasive spinal fixation technology

X-spine Systems, Inc., a global manufacturer of implants and instruments for spinal surgery, announced today that it has entered into an exclusive license agreement with Gamma Spine for the development and distribution of its minimally invasive spinal fixation technology. Gamma Spine, founded by Dr. Vijay Goel, Ph.D., will participate in the development process with X-spine.

9 Mar 2010

Orthofix International announces sale of vascular business assets to Covidien

Orthofix International N.V. announced today it has sold the assets of its vascular business, including its AV-Impulse® mechanical compression technology, to Covidien.

9 Mar 2010

FDA grants Axis Surgical Technologies marketing clearance for C-MOR Visualization Device

Axis Surgical Technologies, Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration to market their C-MOR™ Visualization Device for use in diagnostic and operative arthroscopic and endoscopic procedures. The self-contained portable direct-imaging tool provides illumination and visualization of an interior cavity through either a natural or surgical opening.

8 Mar 2010

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant. A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.

8 Mar 2010

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

biospace med announced today that it has received 510(k) clearance from the FDA to market the Company’s sterEOS 2D/3D workstation for pediatric use in spine applications. The Company’s EOS ultra-low-dose imager previously has been FDA-cleared for use in pediatrics and adults, while sterEOS has previously been FDA-cleared for adult use in spine.

8 Mar 2010

Osteotech's MagniFuse Bone Graft generates $1M in revenue

Osteotech, Inc., a leader in the emerging field of biologic products for regenerative healing, announced today that its MagniFuse™ Bone Graft has generated its first $1 million in revenue during the four month period beginning with the limited launch of the product in late October 2009. Osteotech began the first phase of its strategic limited launch of MagniFuse with the release of three procedure specific forms for posterior cervical and posterolateral spine fusion and spinal deformity procedures.

8 Mar 2010

Pioneering 'brain-washing' treatment helps reduce disability in babies with haemorrhage

The research, led by Andrew Whitelaw, Professor of Neonatal Medicine at the University of Bristol, and Ian Pople, paediatric neurosurgeon at North Bristol NHS Trust, has shown that, after a haemorrhage, the fluid inside the ventricles contains substances potentially toxic to the immature brain.

8 Mar 2010

Spine News and Research

Abbott's sNDA for new six-month 45-mg formulation of Lupron Depot: FDA accepts for review

2010 AAOS conference highlights ways to prevent orthopaedic traumas in children

Cogent Healthcare, Seton Medical Center to develop exclusive hospitalist care delivery system

HyperBranch Medical Technology's surgical sealants to be marketed under new name – Adherus Surgical Sealants

2010 AAOS meeting highlights advancements in back and spine treatment options

Advances in back care and treatment options for slipped disc, spine surgery and vertebral fractures

ESWT applied with SANUWAVE’s Ossatron device results in 80% healing rate of nonunions of the tibia

Stryker's Orthopaedics division to feature two of its latest hip systems at AAOS conference

Artificial periosteum heals serious bone injuries

SMISS launches online series of CME-accredited education modules for spine surgeons

ETEX receives FDA marketing clearance for CarriGen Porous Bone Substitute Material

RepRegen's Strontium-based bioactive glass platform encourages osteoblast cell activity and proliferation

Comparative study reveals no clinical advantages of mobile bearing knee systems over fixed bearing knee systems

X-spine Systems, Gamma Spine announce exclusive agreement for minimally invasive spinal fixation technology

Orthofix International announces sale of vascular business assets to Covidien

FDA grants Axis Surgical Technologies marketing clearance for C-MOR Visualization Device

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

Osteotech's MagniFuse Bone Graft generates $1M in revenue

Pioneering 'brain-washing' treatment helps reduce disability in babies with haemorrhage

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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