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DFine Europe GmbH Accepts Terms Of Preliminary Injuction Issued By German Court For Medtronic GmbH
Medtronic, Inc. announced that DFine Europe GmbH has accepted the terms of a preliminary injunction granted to Medtronic GmbH by a German Competition Court. The preliminary injunction stops DFine Europe GmbH from using certain misleading marketing claims related to Medtronic"s Kyphon® Balloon Kyphoplasty products in Germany.
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First National Study To Examine Rock Climbing-Related Injuries
In the past decade the popularity of rock climbing has dramatically increased. It has been estimated that rock climbing is now enjoyed by more than 9 million people in the U.S. each year. A new study by researchers at the Center for Injury Research and Policy of the Research Institute at the Nationwide Children"s Hospital found that as the popularity of the sport has escalated, so have the number of injuries. Study findings revealed a 63 percent increase in the number of patients that were treated in U.S. emergency departments for rock climbing-related injuries between 1990 and 2007.
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Pluristem Therapeutics Receives European Regulatory Approval For Placental-Derived Stem Cell Clinical Trial
Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX: PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the Paul Ehrlich Institute (PEI), the German competent authority in the European Union, has approved the Company"s Clinical Trial Application (CTA) and granted approval to begin clinical trials with its placental-derived adherent stromal cell product, termed PLX-PAD, for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). In addition, Pluristem has already received approval from the Ethics Committee and, as previously announced, the US Food & Drug Administration (FDA) had cleared the Company"s Investigational New Drug (IND) application to initiate a similar trial in the United States. Both approvals of the CTA and IND clear the way for the world"s "first-in-man" clinical trial using PLX-PAD.
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SPECT MPI With Cardiolite(R) Used In BARI 2D Study To Evaluate Type 2 Diabetes And Coronary Artery Disease Treatment Strategies

Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, announced today that the company"s leading imaging agent, Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), was used in a recently completed five-year study examining appropriate treatment regimens for patients with type 2 diabetes and coronary artery disease. The results of this study, known as The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D), will be presented by the University of Pittsburgh Graduate School of Public Health at a special symposium on Sunday, June 7, 2009, from 4:15 p.m. - 5:15 p.m. (CT) at the American Diabetes Association 69th Scientific Sessions in New Orleans. In the study, SPECT myocardial perfusion imaging (MPI) with Cardiolite® was used to objectively identify coronary artery disease during initial patient recruitment and for subsequent one, three and five-year follow-up of patients enrolled in the study to determine the impact of therapy on left ventricular ejection fraction (LVEF), ischemic burden and scar. One of the two primary objectives for the BARI 2D study was to determine if a strategy of initial elective coronary revascularization combined with aggressive medical therapy results in a lower five-year mortality compared with a strategy of initial aggressive medical therapy alone. Lantheus Medical Imaging, Inc. provided support for the study. "As the number of patients affected by a combination of type 2 diabetes and coronary artery disease continues to rapidly increase, the results of the BARI 2D study could potentially impact millions and better inform patient management decisions as clinicians seek to establish the best possible course of treatment for this growing patient population," stated Don Kiepert, president and chief executive officer of Lantheus Medical Imaging, Inc. "We are proud to have supported and supplied our product for this pivotal clinical effort and recognize the importance of improving treatment protocols for patients with type 2 diabetes to manage cardiovascular risk and prevent further complications." About Cardiolite® Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) is one of the world"s most widely-used cardiac imaging agents and the only technetium labeled myocardial perfusion agent that has been used to image more than 40 million patients. For almost two decades, Cardiolite® has played a vital role in the diagnosis and management of patients with known or suspected coronary artery disease. Cardiolite® is the first technetium labeled myocardial perfusion tracer to provide physicians with prognostic information that can be helpful in making patient management decisions. Cardiolite® is the subject of more than 10,000 publications and the imaging agent of choice within several post marketing cardiology clinical trials -DIAD, COURAGE, ERASE, INSPIRE and CHRISTMAS - which have resulted in changes in patient care. Cardiolite® leads the way with the most FDA approved clinical indications as a myocardial perfusion imaging agent. Indication and Important Safety Information Regarding Cardiolite® Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite® evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent"s labeling). It is usually not possible to determine the age of a myocardial infarction or to differentiate a recent myocardial infarction from ischemia. Exercise and pharmacologic stress testing should be performed only under the supervision of a qualified physician. Cardiolite® has been rarely associated with acute severe allergic events of angioedema and urticaria. The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell. For full prescribing information, please visit http://www.cardiolite.com. Cardiolite® is a registered trademark of Lantheus Medical Imaging, Inc. Lantheus Medical Imaging, Inc.


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