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 and decrease the rates of miscarriage," Dr. Brown added. This trial tests the premise in women who have not been eligible for minimally invasive treatment.

The Fertility Enhancement study is being conducted at the Mayo Clinic in Rochester, Minnesota; Duke University in Durham, North Carolina; Willowbend Health and Wellness in Plano, Texas; and Focused Ultrasound Northwest in Renton, Washington. For more information on the study please visit http://www.clinicaltrials.gov/

To date, InSightec has reported 54 pregnancies, 22 deliveries with 11 ongoing pregnancies with women who previously underwent the ExAblate procedure.

About ExAblate(R) 2000

ExAblate is the first system to use the MR guided focused ultrasound 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. The ExAblate system was approved by the U.S. Food and Drug Administration in 2004 as a treatment for symptomatic uterine fibroids. Over 4,500 women have been treated worldwide to date. ExAblate(R) 2000 received the European CE Mark certification for pain palliation of bone metastases in June 2007.

About InSightec

InSightec Ltd. is a privately held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $120 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/

    Media Contact:
    Hollister Hovey
    Lazar Partners
    +1-646-871-8482
    hhovey@lazarpartners.com


'/>"/>
SOURCE InSightec Ltd
Copyright©2009 PR Newswire.
All rights reserved

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:10/11/2017)... NJ (PRWEB) , ... October 11, 2017 , ... Personal eye wash is a basic ... one eye at a time. So which eye do you rinse first if a dangerous ... have Plum Duo Eye Wash with its unique dual eye piece. , “Whether ...
(Date:10/11/2017)... ... October 11, 2017 , ... Disappearing forests and increased emissions ... over 5.5 million people each year. Especially those living in larger cities are affected ... based in one of the most pollution-affected countries globally - decided to take action. ...
(Date:10/10/2017)... ... October 10, 2017 , ... ... program has won a US2020 STEM Mentoring Award. Representatives of the FirstHand program ... in Volunteer Experience from US2020. , US2020’s mission is to change the trajectory ...
(Date:10/10/2017)... PITTSBURGH, PA (PRWEB) , ... October 10, 2017 ... ... this year’s recipients of 13 prestigious awards honoring scientists who ... be presented in a scheduled symposium during Pittcon 2018, the world’s leading conference ...
Breaking Biology Technology:
(Date:4/18/2017)... Calif. , April 18, 2017  Socionext Inc., a global ... of a media edge server, the M820, which features the company,s ... recognition software provided by Tera Probe, Inc., will be showcased during ... at the NAB show at the Las Vegas ... ...
(Date:4/13/2017)... , April 13, 2017 According to a ... Identity Authentication, Identity Analytics, Identity Administration, and Authorization), Service, Authentication Type, Deployment ... the IAM Market is expected to grow from USD 14.30 Billion in ... Rate (CAGR) of 17.3%. ... MarketsandMarkets Logo ...
(Date:4/11/2017)... , April 11, 2017 No two ... researchers at the New York University Tandon School ... Engineering have found that partial similarities between prints ... used in mobile phones and other electronic devices ... The vulnerability lies in the fact that ...
Breaking Biology News(10 mins):