FDA Clears ExAblate Fertility Enhancement Study in Women With Uterin...(m invasive surgeries. To date over 4000 ...),Health

Date:5/28/2008

m invasive surgeries. To date, over 4,000 women around the world have chosen to undergo the non-invasive ExAblate treatment for their symptomatic uterine fibroids over invasive surgery. Should this trial confirm our expectations, more women will be able to choose a non-invasive treatment."

In October 2007, the European designated Notified Body changed the CE Mark to enable European women with uterine fibroids who may want to become pregnant to consider MRgFUS as a treatment option with their physicians. This change was made based on accumulating data from studies demonstrating that women safely gave birth after undergoing MRgFUS treatment. The ExAblate system received the CE Mark for uterine fibroids in October 2002 and the FDA approved the system as a treatment for symptomatic uterine fibroids in 2004 for patients who had finished their family planning.

About Uterine Fibroids

Uterine fibroids are benign growths in the uterus that affect more than 30% of women of childbearing age. Symptomatic women suffer from extensive and prolonged menstrual bleeding, anaemia, pain, pressure and often infertility. Existing treatment options include hysterectomy, myomectomy and uterine artery embolization that are invasive and minimally invasive, involving hospitalization and several weeks of recovery time. ExAblate is an outpatient procedure and patients return home the same day and to work within one to two days.

About ExAblate

ExAblate is the first system to use the breakthrough MRgFUS technology that combines MRI - to visualize the body anatomy, plan the treatment and monitor treatment outcome in real time - and high intensity focused ultrasound to thermally ablate tumors inside the body non-invasively. MR thermometry, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated and surrounding tissue is spared. Approved by the U.S. Food and Drug Admin
'/>"/>

SOURCE InSightec Ltd Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4
Related medicine technology :

1. FDA Clears Advanced Test for Monitoring Metastatic Colorectal Cancer
2. American Fertility Association Calls for Expanded Research to Advance New Technology to Screen Embryos for Genetic Abnormalities
3. HealthMedias Strongest Single Quarter Results: Growth Driven by Product Enhancements, New Partnerships
4. CellCyte Genetics Signs Collaborative Agreement With Northwestern Universitys Feinberg School of Medicine to Perform Disease Model Outcome Study of CellCytes CCG-TH30 Product Candidate
5. NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
6. First Patient Enrolled in Global Phase III Study of Bevacizumab and Trastuzumab in Early Breast Cancer
7. Abbott Presents Long-Term Data From Extension Study Showing Adult Crohns Patients Treated With HUMIRA(R) (Adalimumab) Maintained Remission
8. QuatRx Pharmaceuticals Announces Presentation of Further Data from Ophena(TM) (Ospemifene) Phase 3 Study for Treatment of Symptoms of Vulvovaginal Atrophy
9. Romark Laboratories Completes Enrollment in U.S. Phase II Study of Nitazoxanide for Chronic Hepatitis C Genotype 1 Non-Responders
10. Uroplasty Highlights Clinical Results From a Study of the Urgent(R) PC Neuromodulation System
11. Study Finds QIAGENs HPV Test Offers Greater Long-term Protection From Cervical Disease Than the Pap