Insightec(R), a global healthcare company focused on creating the next generation of patient care, announced it received market approval by The National Medical Products Administration (NMPA), the Chinese agency for regulating drugs and medical devices (formerly the China Food and Drug Administration, or CFDA).
The approval for the Exablate(R) 4000 (Exablate Neuro) platform, will enable unilateral Focused Ultrasound treatment for patients living with debilitating tremor from Essential Tremor and Tremor-dominant Parkinson's Disease that has not responded to medications.
"This achievement reflects positive momentum to bring Focused Ultrasound to movement disorder patients in China," commented Maurice R. Ferre MD, Insightec CEO and Chair of the Board of Directors. "We are committed to improving the quality of life of patients in China and worldwide with impactful therapeutic treatments."
MR-guided Focused Ultrasound (MRgFUS), also referred to as high-intensity Focused Ultrasound, delivers acoustic energy precisely to the Vim of the thalamus, considered to be responsible for tremor, to heat and ablate the tissue. The procedure does not require surgical incisions, implants or anesthesia.
Nearly 60 leading neurosurgeons in medical centers around the globe are treating patients with hand tremor from Essential Tremor or Tremor-dominant Parkinson's Disease on a regular basis with the Exablate Neuro. Performed in a single session in an MRI suite, many patients experience immediate tremor relief with minimal side effects, returning home the same day.
"There are millions of people in China living with diminished function due to hand tremors from Essential Tremor and Tremor-dominant Parkinson's Disease," said Peng Qiu, Insightec China Country Manager. "Our elderly communities will now have an option that uses highly advanced technology that is less invasive."
Exablate Neuro has received marketing approval for Essential Tremor from the U.S. Food and Drug Administration (FDA) and regulatory bodies in Argentina, Australia, Canada, Chile, Europe, Israel, Japan, Kazakhstan, Korea, Russia, Taiwan and Turkey.
Insightec's Exablate Body system is used in 20 hospitals across China to treat symptomatic uterine fibroids.
Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate(R) Neuro platform uses Focused Ultrasound, guided by MRI, to provide tremor relief to patients with Essential Tremor and Tremor-Dominant Parkinson's Disease. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. Insightec is headquartered in Haifa, Israel, and Miami, with offices in Dallas, Shanghai and Tokyo. For more information, please visit: www.insightec.com.
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