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   제목   SonaCare Medical Receives FDA De Novo Clearance for Sonablate 450
   작성자   관리자     작성일   2015-12-24
   이메일       조회수   339
   첨부파일 Sonacare FDA승인자료.pdf Sonacare FDA승인자료.pdf(174,237byte) 없음 (174,237)
 
Charlottesville, Virginia, October 13, 2015 -- The US Food and Drug Administration has approved SonaCare 
Medical’s Sonablate 450 
focused ultrasound system for the ablation of prostate tissue. Focused ultrasound enables treatment of organ-
confined prostate 
disease while preserving surrounding healthy tissue, without radiation or surgery. 

Sonacare 250“For men with conditions like prostate cancer, the option of a non-invasive procedure that can 
selectively target and 
treat diseased tissue is very appealing,” says Neal Kassell, MD, Chairman of the Focused Ultrasound 
Foundation. “American men 
have been traveling overseas for focused ultrasound treatment for prostate diseases for years, and we are 
pleased that they will 
now have access to this innovative treatment at leading centers in the United States.” 

More than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is 
the leading clinical 
application of the technology -- more than 50% of the patients who have undergone focused ultrasound around 
the globe have had 
prostate disease treated. 

The technology has been successfully used to treat a wide variety of diagnoses, including benign prostatic 
hyperplasia (BPH), 
partial gland cancer, localized whole-gland prostate cancer, and recurrent prostate cancer.

“I believe that we are at a pivotal point in prostate care,” said Michael Koch, MD, Sonablate trial 
investigator and Chairman of 
the Department of Urology at Indiana University. “Simultaneous advances in imaging, fusion technologies, and 
now more focused 
therapies are going to allow us to precisely diagnose prostate conditions and ablate these targeted areas 
rather than perform 
whole gland prostate surgery, which carries a significant burden on quality of life. Focused ultrasound will 
become the work-
horse of subtotal prostate therapy.”

Sonablate-Probe
In addition to Sonablate, EDAP’s Ablatherm focused ultrasound system for treating the prostate is under FDA 
review and may be 
approved soon. Focused ultrasound devices have been cleared to treat the prostate in more than 40 countries 
since the first 
approval in 2000. Several systems for focused ultrasound ablation of prostate tissue are commercially 
available or being 
researched in other geographic regions with differing guidance methods (ultrasound vs. magnetic resonance 
imaging) and approach 
(transrectal or transurethral).

Focused ultrasound is a non-invasive, radiation-free method to treat localized prostate cancer. Using real-
time image guidance, 
the physician directs a focused beam of ultrasound energy to a selected volume in the patient’s prostate 
gland. The energy heats 
the targeted tissue at the focal point and thermally coagulates the targeted cells within seconds. This 
process is repeated until 
the selected volume or the entire gland is destroyed. 

Focused ultrasound treatments are performed with no incisions, leading to few complications and minimal 
discomfort, enabling 
patients to return to daily activities rapidly. Because there is no radiation involved, the procedure can be 
repeated, if 
necessary.

About Focused Ultrasound
Focused ultrasound is an early-stage therapeutic technology with the potential to transform the treatment of 
many serious medical 
disorders. Focused ultrasound is currently approved in the U.S. to treat uterine fibroids and relieve pain 
from bone metastases. 
There are a growing number of clinical applications in various stages of research and development around the 
world, including 
Parkinson’s disease, essential tremor, breast cancer, pancreatic cancer and brain tumors. 

About the Focused Ultrasound Foundation
The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by 
accelerating the 
development of focused ultrasound. Working to clear the path to global adoption, the Foundation coordinates 
and funds research, 
fosters collaboration, and builds awareness. The Foundation is dedicated to ensuring that focused ultrasound 
finds its place as a 
mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the 
Foundation has 
become the largest non-governmental source of funding for focused ultrasound research.

http://www.fusfoundation.org/news/129-press-room/1668-fda-approves-first-focused-ultrasound-system-for-
treating-the-prostate
     
 
         

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