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Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

Genentech, Inc., a wholly owned member of the Roche Group, announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin® (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer.

23 Apr 2010

BSD-2000 Hyperthermia System combined with chemotherapy promising for children with high-risk tumors

BSD Medical Corporation today reported clinical study data showing that hyperthermia, using the BSD-2000 Hyperthermia System, combined with chemotherapy has the potential to improve control rate and long-term survival for the treatment of children with high-risk cancer who have a dismal prognosis.

23 Apr 2010

SVS publishes first supplement on diversity articles to Journal of Vascular Surgery

The Society for Vascular Surgery published its first supplement on diversity articles to its Journal of Vascular Surgery in April 2010.

23 Apr 2010

Tryton Medical widens European availability of Side Branch Stent System

Tryton Medical, Inc., the leading developer of stents designed to definitively treat bifurcation lesions, today announced the launch of the TRYTON Side Branch Stent™ System in Austria, Belgium, Denmark, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal, Spain, and the United Kingdom. The stent is used to treat bifurcation lesions, the largest unmet need confronting interventional cardiology.

23 Apr 2010

Genetic tests that may replace biopsies

Genetic tests conducted on blood samples may replace the current biopsies when it comes to checking if immune systems are rejecting new organs of heart transplant patients. The test would be far less invasive and uncomfortable as compared to the biopsies, not to mention more affordable.

23 Apr 2010

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

23 Apr 2010

Cytori announces launch of PureGraft 250 fat grafting technology at ASAPS meeting

Cytori announces the product launch of PureGraft 250, a revolutionary fat grafting technology that standardizes the graft preparation process for use in aesthetic body contouring at the American Society of Aesthetic Plastic Surgeons meeting.

23 Apr 2010

Boston Scientific introduces new Kinetix Guidewire for use in PCI procedures

Boston Scientific Corporation today announced the launch of its new Kinetix™ Guidewire for use in percutaneous coronary intervention (PCI) procedures. Guidewires are small flexible wires physicians use to deliver interventional devices such as drug-eluting stents. The Kinetix Guidewire features a unique micro-cut nitinol sleeve designed for significantly improved torque control compared to conventional spring coil guidewires.

23 Apr 2010

Cognitive behavior therapy works better as couples therapy for alcohol-dependent women

Barbara McCrady and Elizabeth Epstein wanted to know whether cognitive behavior therapy worked better for alcohol-dependent women when delivered as couples therapy than when delivered as individual therapy. They reported recently that both treatment methods worked well, but women treated in couples therapy maintained their gains a bit better than those in individual therapy. Also, women suffering from depression in addition to alcohol-dependence did better in couples therapy. Their paper appeared recently in the Journal of Consulting and Clinical Psychology.

22 Apr 2010

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Valor Medical's CEO, H. Clark Adams, announced today that Valor's European clinical trial was finalized with 30 patients treated. Mr. Adams stated, "The trial took longer than expected because there are current approved therapies which were used as a first line of therapy. Patients who were enrolled to be treated with Valor's Neucrylate were not always acceptable candidates for these standard-of-care therapies.

22 Apr 2010

IL-10 Gene Therapy helps repair damaged lungs found unfit for transplant

Promising research brings hope for the almost two thousand lung transplant candidates who currently make up The United Network for Organ Sharing's (UNOS) wait list. A new technique that uses gene therapy to help repair damaged lungs previously found unfit for transplant shows promise for addressing the critical shortage of healthy donor organs.

22 Apr 2010

Increase in mammographic density associated with increase of breast cancer in EPT study participants

An increase in breast density appears to be the culprit behind an increase of breast cancer found in women participating in the estrogen and progestin therapy study, a part of the Women's Health Initiative (WHI). That is the finding of a new WHI analysis led by Celia Byrne, PhD, assistant professor at Georgetown Lombardi Comprehensive Cancer Center, and presented during the AACR 101st Annual Meeting 2010 in Washington, DC.

22 Apr 2010

ISHLT announces new guidelines for heart transplant recipients

The International Society for Heart and Lung Transplantation (ISHLT) today announces new guidelines to standardize care for heart transplant patients worldwide. The guidelines demonstrate a united effort to decrease complications, improve outcomes and increase patient survival rates among heart transplant recipients. The guidelines will be presented during today's symposium The ISHLT Guidelines for Heart Transplant Recipients: Towards an International Consensus at the ISHLT 30th Annual Meeting and Scientific Sessions at the Hilton Chicago.

22 Apr 2010

ASTRO President speaks on radiation therapy for treatment of prostate cancer at MEDCAC meeting

ASTRO President Anthony Zietman, M.D., spoke before the Medicare Evidence Development and Coverage Advisory Committee meeting today on radiation therapy for treatment of localized prostate cancer. MEDCAC provides advice and recommendations to the Centers for Medicare and Medicaid Services for what is covered by Medicare and Medicaid, based on scientific evidence.

22 Apr 2010

First-of-its-kind conference on personalized medicine for pediatric patients

The world's leading experts in pediatric pharmacogenomics and personalized medicine are gathering at a first-of-its-kind conference in Kansas City to change the way childhood diseases and illnesses are treated through personalized medicine.

22 Apr 2010

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

StemCells, Inc. announced today that it has submitted a protocol to the FDA for initiation of a second clinical trial of its proprietary HuCNS-SC human neural stem cells in neuronal ceroid lipofuscinosis, which is also often referred to as Batten disease.

22 Apr 2010

Non-invasive coronary CTA cost-effective alternative to invasive cardiac catheterization for CAD evaluation

According to a study conducted at Thomas Jefferson University (TJU), non-invasive coronary computed tomography angiography (CTA) is a cost-effective alternative to invasive cardiac catheterization in the care of patients who have positive stress test results but a less than 50 percent chance of actually having significant coronary artery disease (CAD). The study will be published in the May issue of the American Journal of Roentgenology.

22 Apr 2010

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

The US Food and Drug Administration (FDA) has approved Zortress® (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

22 Apr 2010

Cook Medical enrolls first patient in Formula PTX Balloon Expandable Renal Stent trial

Angiotech Pharmaceuticals, Inc. today announced Cook Medical, a license holder of Angiotech's paclitaxel technology, has enrolled the first patient in its landmark Formula PTX clinical trial. The trial is the first of its kind to evaluate the safety and effectiveness of a paclitaxel-eluting stent to treat renal artery disease, the narrowing of the arteries that supply blood to the kidneys.

22 Apr 2010

Legal case asks who to blame for medical device failure

The New York Times: A legal case now pending asks a question increasingly faced by the medical world -- "who should be held accountable when a company sells a flawed product that can injure or kill patients? Is it the company or the people who run it?"

22 Apr 2010

Medical Procedure News

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

BSD-2000 Hyperthermia System combined with chemotherapy promising for children with high-risk tumors

SVS publishes first supplement on diversity articles to Journal of Vascular Surgery

Tryton Medical widens European availability of Side Branch Stent System

Genetic tests that may replace biopsies

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Cytori announces launch of PureGraft 250 fat grafting technology at ASAPS meeting

Boston Scientific introduces new Kinetix Guidewire for use in PCI procedures

Cognitive behavior therapy works better as couples therapy for alcohol-dependent women

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

IL-10 Gene Therapy helps repair damaged lungs found unfit for transplant

Increase in mammographic density associated with increase of breast cancer in EPT study participants

ISHLT announces new guidelines for heart transplant recipients

ASTRO President speaks on radiation therapy for treatment of prostate cancer at MEDCAC meeting

First-of-its-kind conference on personalized medicine for pediatric patients

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

Non-invasive coronary CTA cost-effective alternative to invasive cardiac catheterization for CAD evaluation

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

Cook Medical enrolls first patient in Formula PTX Balloon Expandable Renal Stent trial

Legal case asks who to blame for medical device failure

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