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Complexity in Medical Technology

SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(TM) Stents More Cost Effective Than Bypass Surgery in Many Patients With Complex Coronary Artery Disease

... on patient characteristics, notably lesion complexity as defined by the SYNTAX Score," said Dr. Cohen. ... fell into the lower or intermediate terciles of complexity had similar rates of MACCE at 12 months. The ... coronary anatomy based on lesion frequency, complexity and location, and assigns a score to each ....

SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery

... defining a new measure for anatomical complexity that seeks to provide guidance to physicians on ... coronary anatomy based on lesion frequency, complexity and location, relying on data from the SYNTAX ... into the lower or intermediate terciles of complexity had similar rates of MACCE (Major Adverse ...

New England Journal of Medicine Publishes Results from Boston Scientific's Landmark SYNTAX(TM) Trial

... broke new ground by scientifically defining a new measure for anatomical complexity -- the SYNTAX(TM) Score(TM) -- which characterizes vasculature based on lesion number, complexity and location. In fact, PCI patients in the lower one-third of raw SYNTAX ...

First Cancer Diagnostic Test Based on Rosetta Genomics' Proprietary MicroRNA Technology Receives Regulatory Approval

... test is based on, have enabled Columbia University Medical Center's High complexity Molecular Pathology Laboratory to develop a highly sensitive and specific ... cancer, is now approved through Columbia University Medical Center's High complexity Molecular Pathology Laboratory. In Addition, the company expects two ...

Vectibix(R) in Combination With Chemotherapy Significantly Improved Progression-Free Survival in First-Line Metastatic Colorectal Cancer

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of ...

Velos, Inc. Releases Software to Support Cancer Centers With New Workflow and Content for NCI Clinical Trials Reporting Program

... and email reporting processes now have a streamlined, single system with one data source, resulting in multiple CTRP-ready outputs. Despite the complexity of the new reporting requirements, all the new content was prepared by Velos teams, using flexible toolkits in the system, with no changes to core ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of ...

AcelRx Announces Positive Phase 2 Results from a Study of ARX-01 Sufentanil NanoTabs in Treating Post-Operative Pain

... IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal. About ARX-01 ...

Diabetes Experts Issue New Recommendations for Inpatient Glycemic Control - Call for Systemic Changes in Hospitals Nationwide

... trial results, it would be a serious error to conclude that judicious control of glycemia in hospitalized patients is not warranted." The complexity of inpatient glycemic management necessitates a system approach that facilitates safe practices that reduce the risk for errors and episodes of ...

AcelRx Initiates a Phase 2 Study to Evaluate Functionality of Its ARX-01 Sufentanil NanoTab PCA System

... IV delivery mode poses infection risk as well as predisposition to analgesic gaps due to infiltrated and dislodged IV catheters. Additionally, the complexity and programmability of IV PCA pumps introduce opportunities for medication errors, which in some instances may be fatal. About ARX-01 ...

EPSScentral Responds to Pandemic Alert

... that transform business and assure the organizational mission at the speed of work. A hallmark is EPSScentral's ability to reduce organizational complexity as processes grow and supporting technologies evolve. Using EPSScentral's approach, their large private and public sector clients typically realize a ...

New Weight Loss Hope for People with Diabetes

... to lose weight- balancing macronutrients like carbohydrates and protein, with overall calories, all while keeping their blood sugar in check. The complexity causes many people to give up due to frustration," explains Dr. Gary Foster, Director of the Center for Obesity Research and Education of the Temple ...

Pfizer and Medivation Initiate Phase 3 Trial of Dimebon Added to Donepezil in Patients with Alzheimer's Disease

... of Dimebon monotherapy in patients with mild-to-moderate AD and builds on results of the first pivotal trial of Dimebon in AD. "Due to the complexity of Alzheimer's disease, the condition often requires combination treatment to help relieve symptoms and slow disease progression," said Bengt ...

CDC Analysis Finds Unique Social and Behavior Intervention Helps Reduce MRSA Rates Up to 62% in Study Hospitals

... of individuals, families, communities, organizations and our natural environment by helping people use concepts emerging from the new science of complexity . Visit www.plexusinstitute.org . The Robert Wood Johnson Foundation focuses on the pressing health and health care issues facing our ...

ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance

... endpoints in patients with CDI . The public comment period for the new draft guidance expires on March 19, 2009. OGD has acknowledged the complexity of the issues involved, and specifically stated that the Agency will carefully consider all comments before responding to ViroPharma's Citizen ...

Independent Data Monitoring Committee Recommends Resuming Enrollment of Non-Squamous NSCLC Patients in the Motesanib MONET1 Trial

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of ...

Researchers Discover Metabolite Linked to Aggressive Prostate Cancer

... invasiveness. This suggests sarcosine as a potential target for future drug development. "This research gets at characterizing the chemical complexity of a sample of cancer progression. In the future, this science will drive how doctors make treatment recommendations for their patients," says study ...

Nplate(R) Approved in the European Union for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modelled by computer or cell culture systems or animal models. The length of ...

Wrist Access Safer, Easier for Many Patients Undergoing Minimally Invasive Treatment of Blocked Heart Arteries

... are extremely low; only 0.3 percent had bleeding complications. None suffered nerve damage. An overnight stay may be advisable, depending on the complexity of the intervention performed, not because of the access approach. The radial approach isn't appropriate for all patients, including those who ...

Isogen Retains Strategic Partner Sheridan Road Financial to Meet Global Biopharma Demand

... its presence in the biopharma industry. "Isogen will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply," said Edwards. "Regulators in the U.S. and Europe increasingly require sterile clinical trials supplies ...

Isogen Launches Major New Facility to Address Global Biopharma Demand

... outsourced alternatives. "Isogen's facility launch will help our customers address major industry dynamics that are reshaping the face and complexity of sterile clinical trials materials supply," said Les Edwards, CEO, Isogen. "Regulators in the U.S. and Europe increasingly require sterile clinical ...

Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized 'Moderate Complexity' by FDA

... the FDA for marketing last month, Xpert MRSA/SA BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate complexity CLIA categorization. The test runs on Cepheid's GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections ...

Boston Scientific to Release Broad Range of Clinical Trial Data on the Performance of TAXUS(R) Coronary Stent Systems at TCT 2008

... Chief Medical Officer at Boston Scientific. "We also plan to present additional detail on the SYNTAX Score -- a new scientific measure for anatomical complexity designed to provide guidance to physicians is assessing treatment options for LM and 3VD patients." Schedule of Events Sunday, October 12 (all ...

Complete Genomics and the Institute for Systems Biology Announce Partnership to Conduct the First Human Genome Population Study

... institute headquartered in Seattle and dedicated to the study and application of systems biology. ISB seeks to use systems methods to unravel the complexity of human biology and identify strategies for predicting and preventing significant diseases such as cancer, diabetes and AIDS. ISB's systems approach ...

Johns Hopkins University Researchers to Clinically Assess Rosetta Genomics' miRview(TM) Squamous Assay

... With Current Diagnostic Methods A Test Based on the miRview(TM) Technology First Approved for Clinical use Through Columbia University's High complexity Molecular Pathology Lab Earlier This Year Rosetta Genomics is Expecting to Launch miRview(TM) Squamous Later This ...

Novel Photoconductive Life Science Research Innovation Enables Rapid, Reproducible, and Non-Invasive Cellular Excitation

... of excitable cells, such as neurons. This novel research innovation will enable researchers to significantly expand the depth, breadth, and complexity of experimental research approaches aimed at understanding and addressing areas of unmet healthcare need such as in Parkinson's disease, Alzheimer's, ...

MicroRNA First Disclosed by Rosetta Genomics may Increase Efficacy of Imatinib (Gleevec(R)(1)) in Glioblastoma

... technology, differentiating squamous from non squamous non small cell lung cancer, is now approved through Columbia University Medical Center's High complexity Molecular Pathology Laboratory. In Addition, the company expects two additional microRNA diagnostic tests applying its technology will be validated ...

Rosetta Genomics Identifies Potential microRNA Biomarkers in Blood Serum

... technology, differentiating squamous from non squamous non small cell lung cancer, is now approved through Columbia University Medical Center's High complexity Molecular Pathology Laboratory. In Addition, the company expects two additional microRNA diagnostic tests applying its technology will be validated ...

Human Genome Sciences Completes Enrollment in Second Phase 3 LymphoStat-B(R) Trial

... have done a tremendous job in completing the randomization and initial dosing of BLISS-52 and BLISS-76 on our original timeline, despite the size and complexity of these studies," said Ann L. Wang, Vice President, Clinical Operations, HGS. "They have enrolled nearly 1700 patients worldwide into these Phase 3 ...

First Molecular Tem-PCR Test to Identify Multiple Forms of Staph and MRSA Obtains CLIA Certificate

... the test was performed. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Centers for Disease Control and Prevention (CDC) ...

XTENT Announces Positive Six-Month CUSTOM III Trial Data Presented at EuroPCR Meeting

... said Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and Principal Investigator for the CUSTOM III clinical trial. "Given the complexity of the patient population from CUSTOM III, we are excited about the results, which are consistent with the outcomes observed from the CUSTOM I and ...

New CoMotion(R) Trials Software by General Dynamics Enables Rapid, Interactive Sharing of Real-time Data for Clinical Trials

... clinics or other medical facilities located worldwide. As more trials adopt computer-based systems to capture electronic data, the volume and complexity of information increases. As a result, software-based tools are needed to streamline the organization, interpretation and decision-making ...

Shire Strives to Increase Adherence Among Chronic Kidney Disease Stage 5 Patients

... conditions. "Nonadherence to phosphate binder therapy is a serious problem and has become a growing issue among CKD Stage 5 patients due to the complexity of managing the condition," said William Finn, MD, professor of Medicine, University of North Carolina School of Medicine at Chapel Hill. "It ...

More Than 1.5 Million Americans Sickened, Injured or Killed by Medication Errors Each Year; Seniors Most at Risk

... "Studies repeatedly demonstrate that most patients do not take their medications as prescribed. A significant cause of this noncompliance is the complexity of the dosage regimens that patients are expected to follow," says Dr. Craig K. Svensson, Pharm.D., Ph.D., Dean of the Purdue University College of ...

XTENT Announces Positive Two-Year CUSTOM I and One-Year CUSTOM II Trial Data for Novel Drug-Eluting Stent System

... "These long term results are exceptional. CUSTOM I and II are unlike any other early stage drug-eluting stent trial because of the lesion length and complexity of the patients treated in these trials," said Professor Eberhard Grube, M.D., chief of cardiology at the HELIOS Heart Center in Siegburg, Germany, ...

Aranesp Phase 3 Study in Patients with Active Cancer Not Receiving Concurrent Chemotherapy or Radiotherapy Presented at AACR Annual Meeting

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time ...

Aranesp ``145 Study'' Shows No Difference in Survival in Patients with Small-Cell Lung Cancer

... and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time ...

Reata's Synthetic Triterpenoids Profiled in Nature Reviews Cancer

... mechanism of the Synthetic Triterpenoids with that of "targeted therapies" currently in vogue in the cancer field. Dr. Sporn argues that the genetic complexity of cancer requires the use of agents with a multi-factorial mode of action, rather than those with high affinity for a single, specific molecular ...
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