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La. Gov. Jindal Signs Law Expanding Protections For Health Workers Who Refuse Services
Louisiana Gov. Bobby Jindal (R) on Tuesday signed into law a bill (HB 517) that expands health care provider "conscience" protections beyond abortion to also include refusals to provide emergency contraception or participate in certain other procedures, the New Orleans Times-Picayune reports. The law provides job protection and legal immunity to "any person" who refuses to provide abortion services, distribute "abortifacient drugs," work on research involving embryonic stem cells or cloning, or participate in physician-assisted suicide or euthanasia. According to the Times-Picayune, the provision that refers to abortifacient drugs is intended to include EC but not other forms of birth control.Jindal"s administration said the law is necessary to protect the individual rights of doctors, nurses, pharmacists and other health care workers whose personal beliefs might conflict with their professional duties. Opponents of the law, including the Planned Parenthood Federation of America and the American Civil Liberties Union, argue that it will restrict patient access to accurate information and timely services (Barrow/Anderson, New Orleans Times-Picayune, 7/8).
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The Family Support Foundation For Mental Illness Launches New Website
The Family Support Foundation for Mental Illness announces today the official launch of http://www.fsfmi.org, a website devoted to increasing awareness and understanding of mental illness issues, supporting legislation that benefits those suffering from mental illness and their families, and fundraising and events that help support qualifying families with significant unreimbursed mental healthcare expenses and other non-profit organizations that have been strong and effective leaders on issues consistent with the Foundation"s mission.
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Rhode Island Hospital First In Country To Enroll Patient In New National Study For Treating Recurrent Chest Wall Breast Cancer
Rhode Island Hospital is one of only four sites across the country to participate in a new clinical trial called the DIGNITY Study. The study will investigate the effectiveness of a chemotherapeutic agent, ThermoDox, used in conjunction with mild hyperthermia (a form of heat therapy) for treating recurrent chest wall breast cancer.
Public Health

Devax Receives IDE Approval To Commence DIVERGE II

Devax, Inc. announced that the U.S. Food and Drug Administration has conditionally approved an Investigational Device Exemption ("IDE") for its AXXESS™ Biolimus A9® Eluting Bifurcation Stent System (AXXESS System), allowing the company to initiate a pivotal clinical trial (DIVERGE II) of the device in the United States. The DIVERGE II study is a multicenter, blinded, controlled, randomized trial comparing the treatment of bifurcation lesions with the AXXESS stent to standard techniques with conventional stents. The Principal Investigator is Jeffrey Moses, M.D., Professor of Medicine and Director of the Center for Intravascular Therapy at Columbia University Medical Center in New York. Bifurcation lesions occur in approximately 20% of patients that are treated for ischemic heart disease with coronary angioplasty and stenting. Recent large scale clinical studies, such as SYNTAX and LEADERS, have shown that lesions located at vessel bifurcations increase the frequency of major adverse cardiac events by as much as 40% compared to lesions in straight vessel segments. Currently, there is no stent with an FDA approved indication for use in bifurcation lesions. Devax has implanted over 430 AXXESS stents in two clinical studies conducted outside the United States. The second of these studies, DIVERGE I, enrolled 302 patients at 16 clinical centers in Europe, Australia, and New Zealand. The 9 month follow up for these patients was presented last October at the Transcatheter Therapeutics conference in Washington, D.C. The data, published in the March 23, 2009 issue of the Journal of the American College of Cardiology, show high rates of clinical success and low rates of restenosis compared to other studies of bifurcations. Discussing the significance of the study, Professor Moses said, "DIVERGE II will be a landmark study because there are many novel aspects to the trial. The AXXESS stent is the first drug eluting stent dedicated solely to bifurcation lesions. We see these types of lesions frequently in daily practice, and they are difficult to treat with conventional stents and techniques. Also, this study is the first randomized study to compare a lesion-specific drug eluting stent to a standard device in a complex vessel anatomy." "This is the first IDE approval of a drug eluting stent specifically designed for use in coronary bifurcations," said Jeff Thiel, President and CEO. "We have focused our attention on being the first to market in the United States with a dedicated DES, and this is an important step toward that goal." The Devax AXXESS System technology is a proprietary self-expanding Nitinol stent specifically designed for the treatment of coronary and vascular bifurcation lesions. The conical shape of the stent is designed to conform to the bifurcation anatomy and provide full access to both branches for additional interventional procedures. Devax, Inc., a private emerging medical device company located in Irvine, California, is engaged in the development of solutions for the treatment of atherosclerotic disease in coronary arteries. Devax, Inc.


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