Navigation Links
FDA Approves Label Change for Non-Invasive Fibroid Treatment
Date:4/7/2009

TIRAT CARMEL, Israel, April 7 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable uterine fibroids. Under the new labeling, the agency allows physicians to treat up to 100% of the fibroid compared to its previous restriction to only treat up to half the fibroid tissue.

"In allowing doctors to destroy the entire fibroid, we believe the FDA has demonstrated further confidence in the safety and efficacy of the non-invasive ExAblate system," said Haywood L. Brown, MD, Chair of Obstetrics and Gynecology/Maternal-Fetal Medicine at Duke Medicine in Durham, North Carolina.

The FDA label change was based on a growing body of evidence supporting the system's safety and efficacy, including the results of a study published in the August 2007 edition of Obstetrics and Gynecology demonstrating that patients experience longer and improved symptom reduction as a greater volume of the fibroid is destroyed.

"We're extremely pleased that the FDA approved this important label change and believe this underscores the safety of our system, the only non-invasive treatment for uterine fibroids available today," said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. "We remain committed to continuously expanding our treatment indications and applications through research. An ongoing research study is evaluating the potential of treating fibroids with the ExAblate system to enhance fertility when other potential causes of women's infertility have been ruled out. The study will compare birth rates of women who underwent ExAblate treatment to those who had a surgical myomectomy."

"Evidence supports removing fibroids that distort the uterine cavity to increase pregnancy rates a
'/>"/>

SOURCE InSightec Ltd
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Brazilian National Biosafety Technical Committee Approves Monsanto Company Insect-Protected Corn Trait
2. FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
3. FDA Approves ACAM2000(TM) Vaccine for Protection Against Smallpox
4. NJ Board of Pharmacy Approves Wedgewood Pharmacy Technician-Training Program
5. FDA Approves Expanded Labeling for Campath(R) to Include First-line Treatment for Leading Form of Adult Leukemia
6. FDA Approves New 300mg Loading Dose Tablet for PLAVIX(R) (clopidogrel bisulfate)
7. FDA Approves Administration of LEXIVA(R) with Lower Dose of Boosting Medication Ritonavir
8. FDA Approves DORIBAX(TM) for the Treatment of Complicated Intra-Abdominal and Complicated Urinary Tract Infections
9. FDA Approves IXEMPRA(TM) (ixabepilone), a Semi-Synthetic Analog of Epothilone B, for the Treatment of Advanced Breast Cancer
10. FDA Approves Genzymes Renvela(TM) for Dialysis Patients
11. FDA Approves New SPRYCEL(R) (Dasatinib) Product Labeling for Patients with Chronic-Phase CML
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... PA (PRWEB) January 15, 2014 The Pittcon ... publisher of Food Safety Tech , an e-Journal and ... signed an agreement for the second year for the co-location ... Pittcon 2014. The partnership provides that the registration fee to ...
(Date:1/15/2014)... 2014 Cynvenio, a cancer diagnostics company ... genomic analysis of tumor cells in the bloodstream, today ... cancer decision support application powered by CollabRx, Inc. ... genomic test, Therapy Finder will provide breast cancer patients ...
(Date:1/15/2014)... 15, 2014 This webinar will focus ... clinical safety assessment in biosimilars. , Regulatory frameworks are ... drug development, however the complex nature of biopharmaceuticals makes ... and efficacy extremely challenging. Based on the specific aspects ...
(Date:1/15/2014)... VA (PRWEB) January 15, 2014 Two ... have continued their sponsorship of an annual competition for ... in, and access to, innovative STEM study. The competition ... TEAMS: Tests of Engineering Aptitude, Mathematics, and Sciences ...
Breaking Biology Technology:Pittcon Announces Second Year Partnership With Food Safety Tech 2Pittcon Announces Second Year Partnership With Food Safety Tech 3Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 3Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5
... Americans living with colorectal cancer will develop liver ... their disease. Radiofrequency ablation, a minimally invasive treatment ... cancer cell death with minimal associated injury to ... their life by nearly three years, note researchers ...
... ... ... EDMONTON , March ... ...
... ) as forefront representative of the company,s new expansive corporate interests. , ... , , ... ... ...
Cached Biology Technology:Living longer: Colon cancer patients gain time with radiofrequency ablation treatment 2Living longer: Colon cancer patients gain time with radiofrequency ablation treatment 3BioMS Medical Announces 2009 Year End Results 2BioMS Medical Announces 2009 Year End Results 3BioMS Medical Announces 2009 Year End Results 4BioMS Medical Announces 2009 Year End Results 5BioMS Medical Announces 2009 Year End Results 6BioMS Medical Announces 2009 Year End Results 7BioMS Medical Announces 2009 Year End Results 8BioMS Medical Announces 2009 Year End Results 9BioMS Medical Announces 2009 Year End Results 10DDS Technologies USA, Inc. (DDSU) Appoints Mina Mar Group as Its Corporate Advisor for a Merger 2DDS Technologies USA, Inc. (DDSU) Appoints Mina Mar Group as Its Corporate Advisor for a Merger 3DDS Technologies USA, Inc. (DDSU) Appoints Mina Mar Group as Its Corporate Advisor for a Merger 4DDS Technologies USA, Inc. (DDSU) Appoints Mina Mar Group as Its Corporate Advisor for a Merger 5DDS Technologies USA, Inc. (DDSU) Appoints Mina Mar Group as Its Corporate Advisor for a Merger 6
(Date:4/23/2014)... "I think one can argue that if we were to ... else that we canthen we can solve the climate problem ... world,s foremost climate researchers, in the current issue of ... to take significant action on climate change now makes it ... the problem, Wigley explains in an exclusive Bulletin ...
(Date:4/22/2014)... Winsor Lowe, interim director of the University of Montana,s Wildlife ... the Proceedings of the National Academy of Sciences ... , ... U.S. Geological Survey, the University of Washington, the Cary Institute ... Forest Service Northern Research Station examined 664 water samples collected ...
(Date:4/22/2014)... PETA International Science Consortium Ltd.,s nanotechnology expert will ... for nanomaterial hazard assessment" at the 7th International ... in Antalya, Turkey. , Dr. Monita Sharma will ... the US National Academy of Sciences, " Toxicity Testing ... ," which recommends use of non-animal methods involving human ...
Breaking Biology News(10 mins):Is nuclear power the only way to avoid geoengineering? 2New research focuses on streamwater chemistry, landscape variation 2
... telltale paw prints with huge 10 centimetre-long nails spoke volumes. ... the most northerly sighting of a grizzly bear. The discovery ... the sole preserve of the polar bear -- Nanuk is ... evidence of the barren ground grizzly bear (Ursus arctos) was ...
... great mysteries in plant science. , Scientists have known since ... of its dramatic effects on plant growth and development since ... works. , In this week's Nature, Indiana University Bloomington biologists ... the protein that, with auxin, influences how and when plant ...
... Proteome Systems, a leading international proteomics company, today ... collaborate on an integrated solution for the analysis ... study of many diseases, including cancer, influenza and ... its GlycomIQ software, a comprehensive platform for the ...
Cached Biology News:Grizzlies set to invade high Arctic? 2At long last, scientists figure out how plants grow 2Integration of Agilent's MS technology, Proteome Systems' software to help scientists in proteomics research 2
Anti-Chicken IgY, (IgG) F(ab')2 Fragment Specific....
Presenilin 2 Immunogen: Synthetic peptide corresponding to residues 31-47 of human Presenilin 2. Storage: -20 C, Avoid Freeze/Thaw Cycles...
Recognizes TWIK-2. Does not cross react with any other known proteins....
Sheep polyclonal to ErbB 2 ( Abpromise for all tested applications). Antigen: Recombinant full length c-ErbB2 protein (Human). Entrez GeneID: 2064 Swiss Protein ID: P04626...
Biology Products: