Insightec: The Taiwanese Food and Drug Administration (TFDA) Approved Exablate Neuro for the Treatment of Essential Tremor

Food and Healthcare Press Releases Wednesday November 29, 2017 09:00
HAIFA, Israel--29 Nov--PRNewswire/InfoQuest

INSIGHTEC , the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the Taiwanese Food and Drug Administration (TFDA) has approved its Exablate Neuro system for the treatment of essential tremor in patients who do not respond to medication.

Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions. The treatment is done under Magnetic Resonance Imaging (MRI) guidance which provides real-time imaging and temperature monitoring. Due to its non-invasive nature, the treatment carries minimal risk of surgical complications such as infections or bleeding. The treatment is performed in a single session with no anesthesia, allowing patients to experience immediate tremor improvement.

The approval was based on data from a randomized, double-blind clinical study conducted in eight medical centers in North America and Asia. The study demonstrated the safety and efficacy of non-invasive thalamotomy with Exablate Neuro.

"This newly TFDA approved Exablate Neuro provides a new treatment option for patients with essential tremor without some of the complications associated with surgery," said Dr. Liu, President of Taiwan Society for Stereotactic Functional Neurosurgery and Radiosurgery. "Furthermore, this technology holds promise for additional neurosurgical procedures," he concluded.

"INSIGHTEC is committed to expanding its footprint into global markets," said Qui Peng, Country Manager, Greater China at INSIGHTEC. "We are very pleased that Taiwanese essential tremor patients now have access to a non-invasive treatment which can greatly improve their quality of life," he added.

Exablate Neuro is also approved by the Japanese Ministry of Health, Labor and Welfare (MHLW), Korean Food and Drug Administration (KFDA) the US Food and Drug Administration (FDA) and Health Canada for the treatment of essential tremor. Exablate Neuro is also approved in Europe and Israel.

ABOUT INSIGHTEC

INSIGHTEC is the world leader and innovator of MR-guided Focused Ultrasound (MRgFUS). The company's non-invasive platforms, Exablate and Exablate Neuro, are proven technology based on sound clinical evidence for treating essential tremor, painful bone metastases and uterine fibroids. The company is dedicated to improving patient lives by collaborating with physicians, medical institutions, academic researchers and regulatory bodies around the world.

For more information, please visit: http://www.insightec.com
Media Contact
Xen Mendelsohn Aderka, VP of Marketing
Xenm(at)Insightec(dot)com
+972-4-8131309
Source: INSIGHTEC

Latest Press Release

The ImplantCenter Marks a New Era in the Hungarian Private Dental Service

The ImplantCenter has recently opened the brand-new operating room suited for more complex treatments. This comes alongside numerous additions such as the launch of the four cosy apartments to rest after treatments at the clinic and an implant education...

Merck and Pfizer Provide Update on Phase III JAVELIN Lung 200 Trial of Avelumab Monotherapy in Previously Treated Patients with Advanced Non-Small Cell Lung Cancer

Merck and Pfizer Inc. (NYSE: PFE) today announced results from the Phase III JAVELIN Lung 200 trial comparing avelumab* to docetaxel in patients with unresectable, recurrent or metastatic non-small cell lung cancer (NSCLC) whose disease progressed after...

PharmaMar Licenses Fully Synthetic Marine-derived Payloads to Seattle Genetics for Use in Drug Conjugates

PharmaMar (MCE: PHM) has announced today the signing of an exclusive licensing agreement with Seattle Genetics Inc. (SGEN: NASDAQ GS) under which Seattle Genetics receives exclusive worldwide rights to certain PharmaMar proprietary molecules for the...

After multiple failed procedures at other medical institutions, Colorado man successfully treated for Atrial Fibrillation at Texas Cardiac Arrhythmia Institute at St. David#s Medical Center

"I was thinking I was on top of the world," Wiseman said. "I was keeping myself in shape. I was taking care of myself mentally and physically. My relationship was solid." Then, during a routine medical exam while serving in the military in California,...

World#s Leading Health Organizations Release Third Edition of Widely Used Resource on Family Planning

Global Handbook Gives Health-Care Providers Accurate and Practical Guidance for Counseling Clients Family planning is considered a development "best buy" and a life-saving intervention for millions of women and girls. Crucial to the success of family...

Related Topics