News | February 08, 2013

EDAP Submits for FDA Review of its Ablatherm High Intensity Focused Ultrasound

HIFU system designed to treatment low-risk, localized prostate cancer

Ablatherm-HIFU EDAP TMS SA FDA Pre-Market Approval Radiation Oncology

February 8, 2013 — EDAP TMS SA announced the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on Jan. 31, 2013 for the company's Ablatherm-HIFU (high intensity focused ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.

Prostate cancer is currently the most common form of cancer among men in the United States with approximately 238,000 new cases for 2013. In addition, men are being diagnosed at an earlier age and at earlier stages of the disease.

Marc Oczachowski, chief executive officer of EDAP TMS, remarked, "We have clearly seen a paradigm shift in prostate cancer, as patients are diagnosed earlier than ever before. Low risk patients need a middle ground between radical treatment, which is often overly-aggressive, and the anxiety of 'watchful waiting.' Ablatherm-HIFU is well-positioned to address this unmet medical need by providing a unique non-invasive and fully robotic treatment option."

Oczachowski concluded, "The PMA submission to the FDA represents a significant milestone in the U.S. regulatory process for Ablatherm-HIFU. The EDAP team, together with its clinical, regulatory and legal advisors, has devoted six years to conducting the United States clinical trial that studied Ablatherm-HIFU as a treatment for localized prostate cancer. I am very proud of the team, and we will continue to work closely with the agency during the final stages of the process."

 

For more information: www.edap-tms.com, www.hifu-planet.com

Related Content

Gamma Knife radiosurgery has become the preferred radiation therapy option for patients with brain tumors at facilities like the Northwestern Medicine Cancer Center, pictured here

Gamma Knife radiosurgery has become the preferred radiation therapy option for patients with brain tumors at facilities like the Northwestern Medicine Cancer Center, pictured here. The technology is favored largely for its ability to precisely target tumors while sparing healthy tissue.

Feature | Radiation Oncology | April 11, 2019 | By Jeff Zagoudis
Brain tumors are some of the most complicated forms of cancer to treat due to their extremely sensitive location.
Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill. Interview with Mark Pankuch, Ph.D.

Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill.
 

Feature | April 02, 2019 | Dave Fornell, Editor and A.J. Connell
April 2, 2019 — Here is the list of the most popular content on the Imaging Technology News (ITN) magazine w
Mississippi Cancer Center Combines RayStation and TomoTherapy for Prostate Cancer Case
News | Treatment Planning | March 08, 2019
Anderson Regional Cancer Center in Meridian, Miss., has treated its first patient using the combination of RaySearch's...
Videos | Proton Therapy | February 28, 2019
ITN Associate Editor Jeff Zagoudis speaks with ...
360_NW_Proton_Center_Inclined_Room_THUMBNAIL
360 Photos | 360 View Photos | February 28, 2019
This is a 360 view of Treatment Room 3 (of 4) at the N...
While surgery is still the gold standard for lung cancer treatment, radiation therapy can offer a less invasive approach with quicker recovery times

While surgery is still the gold standard for lung cancer treatment, radiation therapy can offer a less invasive approach with quicker recovery times.

Feature | Lung Cancer | February 27, 2019 | By Jeff Zagoudis
Lung cancer is the second most common cancer for both men and women in the United States,...
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Radiology Business | February 22, 2019
Imaging Technology News has been recognized with three award nominations from the Jesse H.
The top article from January was about researchers in Sweden using computed tomography (CT) to image the soft tissue of an ancient Egyptian mummy’s hand down to a microscopic level. Non-destructive imaging of human and animal mummies with X-rays and CT has been a boon to the fields of archaeology and paleopathology. Most popular radiology articles and news in January 2019.

The top article from January was about researchers in Sweden using computed tomography (CT) to image the soft tissue of an ancient Egyptian mummy’s hand down to a microscopic level. Non-destructive imaging of human and animal mummies with X-rays and CT has been a boon to the fields of archaeology and paleopathology.

Feature | February 01, 2019 | A.J. Connell and Dave Fornell
February 1, 2019 — Here is the list of the most popular content on the Imaging Technology News (ITN) magazine website
Laurent Levy, CEO of Nanobiotix, explains the use of his company’s nanoparticles to enhance the radiation sensitivity of tumor tissue to improve patient outcomes

Laurent Levy, CEO of Nanobiotix, explains the use of his company’s nanoparticles to enhance the radiation sensitivity of tumor tissue to improve patient outcomes. The metallic-based nanoparticles show up on CT scans so it can be used as a permanent fiduciary marker to track tumor response. The images show the initial tumor and enhancement areas due to the nanoparticles and the resulting outcomes following treatment. Photo by Dave Fornell

Feature | Radiation Oncology | January 30, 2019 | By Dave Fornell
Artificial intelligence (AI) has been the hot topic discussed at all trade shows, and the...