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| News in Brief - June 2009 Brief items of the latest industry news... |
| Appointments - June 2009 Stay up to date with the latest changes in personnel... |
| Synthes Agree Settlement Over Clinical Trial Payments - June 2009 Synthes has agreed a settlement with The Office of the Attorney General... |
| FDA Approves ‘Total Ankle Replacement’ System - June 2009 The U.S. FDA has approved a total ankle replacement system for... |
| Actifuse™ Can Provide ‘Gold Standard’ Lumbar Spine Disease Therapy - Study - June 2009 ApaTech has presented new clinical data for its synthetic bone... |
| Prostate Cancer Patients Susceptible to Bone Loss - June 2009 GTx, Inc. has announced that, in a recent Phase III clinical... |
| Once-Daily VTE Drug ‘Significantly More Effective’ - June 2009 Data from the pivotal Phase III RECORD4 clinical trial has... |
| Easyspine Gains Japan Approval - June 2009 LDR has obtained approval in Japan to market their Easyspine... |
| LPE Medical and Orthoplastics Form Orthoproducts Group - June 2009 In what is an important development in the UK Orthopaedic supply... |
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Company News In Brief
 curasan AG presented research results on Cerasorb® M at the 57th Congress of the Association of South-German Orthopaedic Surgeons.
The bone substitute’s use in acetabular cup revisions was highlighted in a lecture that reported the positive experiences for filling defects during hip endoprostheses replacement procedures. Surgeons achieved good bone consolidation with Cerasorb® M in over 30 patients between the ages of 60 and 90 years.
“Because of the aging population, orthopaedic surgeons will be increasingly confronted with the problem of cup loosening in older patients”, said Dr. Wolf-Dietrich Hübner, Director of the Medical Division at curasan AG.
“This will inevitably lead to an increase in the number of revision procedures required.”
Particularly in older women, bone stock instability frequently becomes apparent during operations, with bone cement used to fill defects. This makes further replacements very difficult. Many patients also do not have enough endogenous bone to fill large defects. This provided the impetus for Prof. C. H. Siebert and Dr. S. Berger to investigate the use of the Cerasorb® M bone substitute and construction material for this.
Cerasorb® M (ß-tricalcium phosphate) was used in over 30 operations - in 13 of these cases mixed with autogenous bone. The subsequent observation period was at least 2 years. In 27 cases, treatment results were satisfactory, even though four patients received replacement under septic conditions. “These results are clearly attributable in large measure to Cerasorb® M’s phase purity of over 99%”, said Dr. Hübner.
“Furthermore, there is no potential for disease transmission with Cerasorb® M, in contrast to established products made from human or bovine bone material.”The Patents Court, in the High Court of Justice of England and Wales, has ruled as invalid 7 out of the 10 claims asserted against Smith & Nephew of the Negative Pressure Wound Therapy (NPWT) patent EP 0620720, that is licensed to Kinetic Concepts, Inc. The three other claims asserted in the patent remain in effect in the UK but are subject to appeal.
This judgement has invalidated the main claim of the EP 0620720 patent. This complements the German decision in March where the Federal Munich Patent Court ruled (subject to appeal) that all claims of the patent are invalid.
“This ruling has no impact on Smith & Nephew’s ability to sell gauze-based NPWT systems, and we will continue our efforts to ensure that clinicians have options in NPWT. We intend to pursue the remaining asserted claims as a matter of urgency,” said Robin Carlstein, Senior Vice President of Advanced Wound Devices at Smith & Nephew.Hospital de São João, one of Portugal’s largest hospitals, has selected Sectra as its provider of PACS products and services.
Throughout the agreement, Sectra will supply PACS solutions and direct service and support to Hospital de São João. With this order, Sectra is the main contractor in digital radiology solutions for all five public hospitals in Porto.
Hospital de São João is located in Porto, the second-largest city in Portugal. In total, the hospital performs approximately 300,000 examinations annually, a figure that is projected to grow to 400,000 over the next few years with the integration of other clinical departments such as gastro-enterology, cardiology and other image-producing departments.
“Sectra has extensive experience in delivering and servicing mission-critical IT systems,” said Afonso Pedrosa, IT Manager at Hospital de São João.
“Being the main contractor for all public hospitals in Porto demonstrates the true strength of Sectra’s competitive position and our commitment to fulfilling our customers’ needs, and highlights the skill and dedication of our highly professional team,” says Carlos Cardoso, President of Sectra Iberia.Synthes Agree Settlement Over Clinical Trial Payments Synthes has agreed a settlement with The Office of the Attorney General for the state of New Jersey to resolve allegations that the company failed to disclose financial conflict of interests among doctors who conducted clinical testing on its products. Under the Assurance of Voluntary Compliance agreement, Synthes must disclose any future payments made by the company to physicians conducting US-based clinical trials on its devices, as well as any investments held by such physicians in the devices they test. Synthes has also agreed to stop paying clinical trial physicians with company stock or stock options. The investigation focused on allegations that most doctors conducting clinical trials for Synthes’ ProDisc total disc replacement system, ProDisc-L and ProDisc-C had a financial stake in the outcome. In a letter to the FDA, the Attorney General, Anne Milgram, called for the Synthes agreement terms to become “best practices” for disclosure among medical device makers. She said the “apparently common” practice of clinical trial physicians being paid by - or holding considerable stock in - companies whose products they are testing is wrong, and leaves the clinical trial process lacking in integrity. The letter called upon the FDA to more effectively address the problem by adopting rules that require full public disclosure. The Synthes issue stemmed from when ProDisc was developed by the start-up company Spine Solutions. The ProDisc clinical investigators were said to be offered substantial investment opportunities in Spine Solutions, as well as consulting contracts that included gifts of company stock and stock options. Synthes subsequently bought Spine Solutions in 2003, but failed to fully disclose these conflicts of interest to the FDA. Milgram said that Synthes’ failure to adequately disclose “should have been obvious from even a cursory review of its FDA submissions,” yet the FDA “did nothing” and ultimately approved Synthes applications for approval without delay or further inquiry into the apparent conflicts. Although admitting no wrongdoing, Synthes has agreed to publicly disclose, on its website, any financial relationships with doctors conducting its clinical research trials. The company has also committed to disclosing such financial conflict of interest to the research institutions that serve as clinical trial locations, and to the FDA. Synthes has also made further concessions such as the cutting the practice of paying compensation based on clinical trials, and offering a series of measures aimed at maintaining financial transparency in the area. Synthes will also pay the state a total of $236,000 as reimbursement for fees and costs related to the investigation. Milgram said the Synthes settlement was the first of its kind because of its disclosure provisions, as well as its ban on compensating clinical researchers with company stock, which was an “unacceptable” widespread industry practice. Milgram also announced that her office issued subpoenas “to five major medical device manufacturing companies seeking information about their business practices.” Two of these companies were confirmed as Stryker and Biomet, who said they were currently in the process of evaluating the scope of the subpoenas and their respective responses. “Medical device makers have a duty to make certain that clinical trial results are accurate and unbiased,” Milgram said. “In creating these financial incentives for doctors, Synthes and the rest of the industry have done the exact opposite. Going forward, if the industry will not address this problem voluntarily, we most certainly will.” This news follows on from the 18-month period of deferred agreements with the US Justice department in regards to ‘kickbacks’ that led to substantial settlement payments from Smith & Nephew, DePuy, Biomet and Zimmer. FDA Approves ‘Total Ankle Replacement’ System The U.S. FDA has approved a total ankle replacement system for arthritic or deformed ankles that may preserve some range of motion in the joint. The Scandinavian Total Ankle Replacement (STAR) System from Small Bone Innovations is a mobile-bearing device, which relies on bearings that move across a surface of polyethylene, a flexible plastic - the first of its type. Once arthritis or injury destroys the cartilage that cushions the ankle bone, the joints can become painful enough to warrant total ankle replacement. The STAR System is an alternative to fusion surgery and may allow for greater rotation and movement in the joint. "This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle," said Daniel Schultz, director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.” The FDA has already cleared several fixed-bearing ankle devices, which are also options to fusion surgery. In fixed-bearing ankle system, the articulating surface is molded, locked or attached to one of its metallic components. For two years, researchers followed a subgroup of a 224-patient clinical study and found that the STAR system demonstrated similar rates of adverse events, surgical interventions and major complications as fusion surgery. As a condition of FDA approval, the company will evaluate the safety and effectiveness of the device during the next eight years. Actifuse™ Can Provide ‘Gold Standard’ Lumbar Spine Disease Therapy - Study ApaTech has presented new clinical data for its synthetic bone graft, Actifuse™, suggesting that it can provide a preferable alternative to the current ‘gold standard’ therapy, Iliac Crest Bone Graft (ICBG), in the treatment of patients with degenerative lumbar spine disease.  Three new studies presented at the North American Spine Society (NASS) Spring Break Meeting have shown that Actifuse™ has the potential to be as clinically effective as ICBG, without the problems associated with the latter.
The first study involved 38 patients with a diagnosis of lumbar stenosis, followed up two years after treatment with Actifuse™ as part of a standard lumbar fusion procedure. Fusion rates were graded at two years in excess of 81%. Results also showed a 68% decrease in pain experienced pre-operatively, as measured by the Visual Analogue Scale (VAS) (8.0 pre-operatively to 2.6 at two years), with 95% of patients reporting satisfaction levels that were good or excellent. There were no incidences of infection, bone graft complications or instrumentation failures.
The authors concluded that that both clinical results and fusion rates were comparable to those routinely achieved with ICBG, without any adverse effects.
The second study involved 69 patients with degenerative lumbar spine disease, of which 45% had two levels fused, and 41% were fused at three or more levels. All patients underwent a standard posterolateral spinal fusion using Actifuse™. 81% of patients had radiographic evidence of bilateral bridging bone one year after surgery. 57% of patients reported relief from back pain, and 67% reported relief of leg pain. The authors concluded that Actifuse™ is an excellent alternative to ICBG for posterolateral spinal fusion in patients requiring surgical treatment for degenerative disease of the lumbar spine.
In a third study presented at NASS Spring Break, rhBMP-2, a widely-used biological treatment, was shown to be associated with double the levels of new leg pain compared to Actifuse™ following Minimally Invasive Transforaminal Lumbar Interbody Fusion (MITLIF), a standard procedure for spinal fusion.
483 patients undergoing single level MITLIF were assessed: 411 were given rhBMP-2 and 93 Actifuse™. The incidence of new post-operative leg pain with rhBMP-2 is twice that seen with Actifuse. In addition, post-operative VAS scores for upper and lower leg pain at 6-12 weeks were significantly lower in patients given Actifuse™.
“These results for Actifuse™ are very exciting. We are proud to provide a new option for physicians in the treatment of degenerative lumbar spine disease” said ApaTech CEO Simon Cartmell.
“These data further demonstrate ApaTech’s leadership in the science of silicon and the biostimulative effects of Actifuse™.”
Prostate Cancer Patients Susceptible to Bone Loss GTx, Inc. has announced that, in a recent Phase III clinical trial of advanced prostate cancer patients being treated with androgen deprivation therapy (ADT), nearly one in four placebo group subjects developed bone fractures or critical bone loss (>7% loss) within two years. The analysis of placebo group subjects was from the Phase III clinical trial evaluating toremifene 80mg for the prevention of bone fractures in men with prostate cancer on ADT. The results demonstrate the risk of fracture for men with prostate cancer on ADT. During the two year trial, 9.9% of these men had a nontraumatic fracture (morphometric vertebral fracture or clinical fragility fracture), and nearly one in four, 23.9%, experienced either a nontraumatic fracture or greater than 7% bone loss, a predetermined level of bone loss at which men were considered to be at high risk for fracture and were removed from the study for safety reasons. “The toremifene 80mg Phase III clinical trial is the first large prospective study evaluating fractures in men with prostate cancer on ADT. The data from this clinical trial underscore that men on ADT are indeed at high risk for skeletal fractures,” said Daniel Lin, Chief of Urologic Oncology, University of Washington School of Medicine, and a Principal Investigator in the study. “ADT is an important treatment for men with prostate cancer. However, ADT itself over time can cause serious, life threatening side effects, such as fractures.” The two year, double-blind, placebo-controlled, randomized study of 1,389 ADT patients, was conducted at approximately 150 clinical sites in the United States and Mexico. The primary endpoint was new morphometric vertebral fractures measured by dual X-ray absorptiometry (DEXA). Key secondary endpoints included bone mineral density, lipid changes, hot flashes, and gynecomastia. In the study, toremifene 80mg treatment demonstrated statistically significant reductions compared to placebo in new morphometric vertebral fractures (the primary endpoint), in all nontraumatic fractures, and in first of either a nontraumatic fracture or greater than 7% bone loss. Toremifene 80 mg treatment compared to placebo also resulted in statistically significant increases in bone mineral density at the lumbar spine, hip, and femur; improvements in lipid profiles including a reduction in LDL, triglycerides and total cholesterol and an increase in HDL; and improvements in breast pain and tenderness. Toremifene 80 mg was well tolerated. Among the most common adverse events that occurred in over 2% of study subjects were joint pain (treated 7.3%, placebo 11.8%), dizziness (treated 6.3%, placebo 5.0%), back pain (treated 5.9%, placebo 5.2%), and extremity pain (treated 5.0%, placebo 4.4%). Once-Daily VTE Drug ‘Significantly More Effective’ Data from the pivotal Phase III RECORD4 clinical trial has shown that Bayer’s novel anticoagulant Xarelto® (rivaroxaban), taken as one tablet, once-daily, was significantly more effective at reducing the occurrence of venous blood clots following elective total knee replacement surgery (TKR) than twice-daily injectable, enoxaparin. These results make Xarelto the only oral anticoagulant to have demonstrated superior efficacy compared to enoxaparin at its higher US-approved dosing regimen of 30mg twice-daily for venous thromboembolism (VTE) prevention in patients undergoing TKR. Professor Beverley Hunt, Consultant Haematologist and Medical Director of Lifeblood: The Thrombosis Charity, said: “We want to ensure that every adult admitted to hospital in the UK receives appropriate prevention against hospital-acquired clots, which are the number one cause of preventable deaths in hospital care. We welcome rivaroxaban which has the advantages of being a tablet and has proven to be superior to the gold standard in clinical trials after knee replacements. In addition to these efficacy advantages, rivaroxaban has other benefits compared with currently available treatment options because it is given as a one tablet, once-daily, fixed-dose regimen that eliminates the need for any routine monitoring (such as clotting, liver function etc) or dose adjustment. VTE causes 10% of all deaths from UK hospital stays - up to 32,000 people each year. More than half of the 90,434 people undergoing elective hip or knee replacement every year in England could develop a potentially fatal blood clot if no preventative treatment is given. RECORD4 forms part of the RECORD clinical trial programme, which involved more than 12,500 elective total hip or knee replacement surgery patients. Prof Ajay Kakkar, Professor of Surgical Sciences at the Barts and London School of Medicine and Dentistry, and Director of the Thrombosis Research Institute, said: “Data from the RECORD 4 study confirm the efficacy and safety of the novel anticoagulant rivaroxaban, demonstrated in three previous studies. Rivaroxaban will add to our armamentarium of thrombosis-preventing strategies and help in their use after hospital discharge.” Easyspine Gains Japan Approval LDR has obtained approval in Japan to market their Easyspine posterior osteosynthesis system. The Easyspine system was approved by the Ministry of Health, Labor and Welfare, working closely with the Yufu Itonaga Company in Tokyo to obtain this approval. The Yufu Itonaga Company will distribute and support the Easyspine line. Kaoru Sakamoto, President and CEO of Yufu Itonaga comments, “We have been working very diligently and closely with LDR for almost 3 years to achieve this important milestone. We are proud to be the first in Japan to obtain approval to market a spine system that is delivered sterile to the customer, a very important benefit of the Easyspine system. We have a very strong organization that is prepared and eager to serve our Japanese surgeon customers.” Developed in France by LDR Médical with strong surgeon involvement, Easyspine has been used successfully in thousands of procedures worldwide to date. Its patent-pending pedicle screw design, with integrated multi-axial capability, provides flat-on-flat screw to rod purchase, and can achieve a variety of rigidities by accommodating rods of different thicknesses. Christophe Lavigne, CEO of LDR said: “The benefit of being able to offer a system that is delivered sterile gives us a strong advantage over other companies.” LPE Medical and Orthoplastics Form Orthoproducts Group In what is an important development in the UK Orthopaedic supply base, Orthoplastics and LPE Medical, have been integrated within a new group called Orthoproducts. LPE Medical will be renamed as Orthoponents Ltd and both companies will be part of the new group. The aim is to provide the Orthopaedic device manufacturers globally with a stronger supply partner with a full range of services. Orthoplastics will continue to supply implantable and non-implantable grades of plastics from its existing facility near Manchester, England and Orthoponents will continue to provide project management, metal components as well as contract clean and pack from its current facility on the south coast of the UK. There are no plans to consolidate the facilities so product and process validations and qualifications remain unchanged. For LPE, it is a change of name only. This integration is tightly focused on the Orthopaedic Industry and is expected to continue to deliver superior customer service and quality to the global Orthopaedic community. For further information regarding the transaction or the capabilities of the two companies, they can be contacted at the following:
Stay up to date with the latest changes in personnel  Medsmart Solutions have appointed two new members to their team as the company continues to expand its operations.
A supplier of a wide range of clinical technology products for use in orthopaedic and reconstructive surgery, Medsmart Solutions continue to evolve, bringing innovative products to the global medical market.
The new appointments, Jonathan Warner and Robert Woodcock, will be responsible for new business development and marketing respectively.
Jonathan Warner, who joins the company as Business Development Manager, is a graduate of the University of Northumbria and has substantial international sales experience opening up new business opportunities in Europe, North America and the Caribbean. He is now looking to use that knowledge and experience to help drive Medsmart Solutions forward into new markets worldwide.
 Robert Woodcock joins the company as Marketing Manager after several years developing and managing an extensive marketing operation for a major UK based organisation.
Both Jonathan and Robert are looking forward to bringing all that experience to bear in helping to raise the profile of Medsmart Solutions across the globe.
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