High-intensity Focused Ultrasound - History

History

The first investigations of HIFU for non-invasive ablation were reported by Lynn et al. in the early 1940s. Extensive important early work was performed in the 1950s and 1960s by William Fry and Francis Fry at the University of Illinois and Carl Townsend, Howard White and George Gardner at the Interscience Research Institute of Champaign, Ill., culminating in clinical treatments of neurological disorders. In particular High Intensity ultrasound and ultrasound visualization was accomplished stereotaxically with a Cincinnati precision milling machine to perform accurate ablation of brain tumors. Until recently, clinical trials of HIFU for ablation were few (although significant work in hyperthermia was performed with ultrasonic heating), perhaps due to the complexity of the treatments and the difficulty of targeting the beam noninvasively. With recent advances in medical imaging and ultrasound technology, interest in HIFU ablation of tumors has increased.

The first commercial HIFU machine, called the Sonablate 200, was developed by the American company Focus Surgery, Inc. (Milipitas, CA) and launched in Europe in 1994 after receiving CE approval, bringing a first medical validation of the technology for benign prostatic hyperplasia (BPH). Comprehensive studies by practitioners at more than one site using the device demonstrated clinical efficacy for the destruction of prostatic tissue without bloodloss or long term side effects. Later studies on localized prostate cancer by Murat and colleagues at the Edouard Herriot Hospital in Lyon in 2006 showed that after treatment with the Ablatherm (EDAP TMS, Lyon, France), progression-free survival rates are very high for low- and intermediate- risk patients with recurrent prostate cancer (70% and 50% respectively) HIFU treatment of prostate cancer is currently an approved therapy in Europe, Canada, South Korea, Australia, and elsewhere. Clinical trials for the in the United States Sonablate 500 are currently ongoing for prostate cancer patients and those who have experienced radiation failure.

Magnetic Resonance Guided Focused Ultrasound MRgFUS was first cited in the article "On-line MRI monitored noninvasive ultrasound" by Hynynen K., Damianou C., Darkazanli A., Unger E., Levy M., SchencK J. in Proceedings of the annual international conference of the IEEE engineering in medicine and biology society,October 1992. “MR-guided focused ultrasound surgery,” Cline HE, Schenck JF, Hynynen K, Watkins RD, Souza SP, Jolesz FA Journal of Computer Assisted Tomography was published nearly the same time. U.S. Patent #5247935. had been previously Filed on March 19, 1992 The technology was later transferred to InsighTec in Haifa Israel in 1998. The InsighTec ExAblate 2000 was the first MR Guided focused ultrasound system to obtain FDA market approval in the United States.

Haifu Model JC and JC200 by ChongQing Haifu Ltd. are complete ultrasound guided tumor treatment systems, and they were CE approved in 2005 for benign and malignant tumors.

HIFU-2001(Sumo Corporation Ltd) is an enhanced technology treatment system that does not require anesthesia. Since 2001 it has been used in Asian countries to treat Liver/Pancreas/Bladder/Uterus/Kidney. CFDA/CE/ISO 13845 Approved!

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