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

Merck Signs Distribution Agreement with Avanti(R) Polar Lipids

Merck , a leading science and technology company, today announced that it has entered into an agreement with Avanti(R) Polar Lipids to be the exclusive multinational distributor of the USA-based company's research lipids portfolio outside of the United...

Xultophy(R) Significantly Reduces Blood Sugar Levels, Body Weight and Risk of Hypoglycaemia for People With Type 2 Diabetes in Real-World Setting

Newly published data from real-world European clinical practice has shown that Xultophy(R) (insulin degludec/liraglutide) significantly reduced blood sugar levels in people with type 2 diabetes after six months.[1] The study looked at people with type 2...

Tresiba(R) Reduces Hypoglycaemia Regardless of Blood Sugar Level

People with either type 1 or type 2 diabetes treated with Tresiba(R) had fewer episodes of low blood sugar (hypoglycaemia) compared with people on insulin glargine U100 regardless of whether they had achieved blood sugar targets.[1] These new post-hoc...

Ryzodeg(R) Significantly Reduces the Risk of Low Blood Sugar in People With Type 2 Diabetes who Fast During Ramadan

In people with type 2 diabetes who fast during Ramadan, Ryzodeg(R) (insulin degludec/insulin aspart) reduced the overall rate of low blood sugar (hypoglycaemia) including severe episodes by 62% and the rate of nocturnal hypoglycaemia by 74% versus...

Interim Results of First-Ever Global Survey Show People with Type 2 Diabetes Underestimate their Cardiovascular Risk

- Globally, cardiovascular disease (CVD) is the most common cause of death in people with type 2 diabetes[1] - 1 in 3 respondents considered themselves to be at low risk of CVD[2] - 1 in 6 respondents had never discussed type 2 diabetes and...

Related Topics