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Electronic Health Records For The U.S. Difficult To Do, But Could Pay Off
"Creating an electronic health record for every American by 2014 is a big part of Obama"s agenda but it may be easier said than done," CNN Money reports. "For one, the cost can be prohibitive - easily running into the tens of millions of dollars. Getting physicians on board can be challenging. And the sheer magnitude of implementing the technology can be overwhelmingly cumbersome - translation: try creating a system for a hospital that serves 600,000 patients." The ambitious idea is to eventually create a network between hospitals and doctors offices all across the nation (Goldman, 7/31).

$90 Million In Recovery Act Funds To Bolster Water Services In Indian Country And Create Jobs
The U.S. Environmental Protection Agency (EPA) and the U.S. Department of Health and Human Service"s (HHS) Indian Health Service (IHS) announced $90 million in funds from the American Recovery and Reinvestment Act of 2009 for improved access to vital drinking water and wastewater services in the American Indian and Alaska Native communities. The funds will be invested in "shovel ready" infrastructure projects designed to better protect human and environmental health in Indian Country and to create jobs.
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Definitive Outcomes Of Radiofrequency Ablation For Barrett's Esophagus Using The HALO Ablation System Reported At The Digestive Disease Week
Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago this week, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett"s esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S. registry of 429 patients, a randomized trial comparing ablation to endoscopic resection, and the largest European series to date in patients with high-grade dysplasia and early cancer.
Public Health

FDA Approves SBi's S.T.A.R.(R) Total Ankle Replacement System

Small Bone Innovations, Inc. (SBi), a leading provider of innovation, products, technology and education for the small bone & joint segment of the orthopedics industry, announced that the U.S. Food and Drug Administration (FDA) has approved SBi"s Scandinavian Total Ankle Replacement (S.T.A.R.®) system to treat U.S. patients. S.T.A.R. has received pre-market approval (PMA) to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. S.T.A.R. has more than 19 years of clinical experience and the current design has been implanted in over 15,200 patients worldwide. Additionally, there have been 35 peer-reviewed clinical outcomes papers published on S.T.A.R.; SBi believes that this number of papers is more than any other mobile-bearing total ankle arthroplasty device. A U.S. Investigational Device Exemption (IDE) Clinical Trial of S.T.A.R. was initiated in August, 2000 as a prospective, multi-center controlled pivotal study to compare the safety and efficacy of S.T.A.R. to ankle fusion (the current standard of care). The study, which followed patients for a minimum of 24 months, is the only U.S. IDE clinical trial to have been completed on a three-piece, mobile-bearing, non-constrained, uncemented total ankle replacement system. More than 670 patients were enrolled in the pivotal and continued access phases of the IDE clinical trial. The lead investigators were Roger A. Mann, MD, of Oakland Bone & Joint Specialists, Oakland, CA and consulting surgeon at the Steadman-Hawkins Clinic, Vail, CO and Michael J. Coughlin, MD, of the Idaho Orthopaedic Institute at St. Alphonsus Regional Medical Center, Boise, ID. Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The "Instructions for Use" and "Patient Labeling" issued by the FDA indicate that "S.T.A.R. patients had superior effectiveness compared to ankle fusion and had comparable safety results compared to ankle fusion in the clinical trials. No other total ankle replacement system can make this claim." Additionally, Mr. Viscogliosi continued, "S.T.A.R. was less invasive than fusion, with less blood loss, shorter operating time, and better pain relief. We are now able to provide surgeons and their patients with a proven, advanced technology that we believe will change the standard of care from fusion to total ankle arthroplasty." Currently, there are a few 510(k) ankle replacement devices cleared for U.S. marketing as an alternative to fusion. All of these ankle replacements are fixed-bearing devices that limit motion and are indicated for use with bone cement. "S.T.A.R. is the only FDA-approved total ankle replacement system for uncemented use, which allows for better bone in-growth, stabilization and bone preservation," Mr. Viscogliosi concluded. Thomas A. Crowley, President of SBi, said: "We expect high patient demand for the S.T.A.R. total ankle replacement system and we will strategically manage that demand through a controlled introduction and surgeon training, supported by continued long term follow-up of patients for eight years." Roger A. Mann, MD said: "There is already widespread awareness and interest in the S.T.A.R. ankle replacement among U.S. foot and ankle surgeons. For those of us who participated in the clinical trial and have observed the successful clinical outcomes among our patients, this may well be an important moment in orthopedics, similar to those we"ve seen in hip, knee and spine, when the gold standard transitioned from fusion to arthroplasty." Surgeons mentioned in this release provide consulting services to SBi. Small Bone Innovations, Inc.


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