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

Historic Deal Signed Between Panacea Biotec and Serum Institute of India

Panacea Biotec Ltd. (PBL), India's leading biopharmaceutical company and among the largest manufacturer of vaccines, has signed two long-term collaboration agreements with Serum Institute of India Pvt. Ltd. (SII), world's largest manufacturer of vaccines...

The Consumer Health of Merck Walks the Talk with its WE100 Movement

- Consumer Health accelerates its WE100(R) movement by launching new partnership programme with pharmacists in the UK on enabling 100 years of healthy living - Femibion(R) celebrates working mums with new "MumPlus" campaign - Expansion of Vitamin D brand...

Mindray launches BeneVision N1 for uninterrupted monitoring during intra and out-of-hospital patient transport

The revolutionary transport solution extends intelligent monitoring to out-of-hospital transport settings such as ambulances, helicopters, and civic flights. Mindray, a global medical equipment solution provider, announced the release of BeneVision N1...

Photo Release: Fujitsu works with the Thai Red Cross Society to contribute to society through the annual 20th FTH Voluntary Blood Donation Day

Ms. Krittinee Sivakul, Head of HR & Administration Group, Fujitsu (Thailand) Co., Ltd. (FTH) led a group comprising company management and staff at a special executives and 187 employees of the company recently donated blood to the Thai Red Cross...

Systech Europe(TM) Announces Rapid Expansion of Customer Base and Pharmaceutical Serialisation Partners Ready to Meet the FMD Regulation

Systech International , the global technology leader in serialisation, track and trace, and brand protection grew its European presence in 2017 by 50% with new accounts in France, Germany, Greece, Turkey, and Finland. The company also added new...

Related Topics