INSIGHTEC’s system for the treatment of essential tremor approved by FDA
12 July, 2016
The system based on ultra-sound waves offers a new, non-invasive treatment, which does not require. Elbit Medical’s share – a major shareholder in INSIGHTEC – leaped following the announcement
The system based on ultra-sound waves offers a new, non-invasive treatment. Elbit Medical’s share – a major shareholder in INSIGHTEC – leaped following the announcement
Israeli med-tech company INSIGHTEC, the developer of a non-intrusive ultrasound device for the treatment of internal tumors has been approved by the U.S food and drug administration (FDA) after passing phase III testing. The system is intended for essential tremor patients unresponsive to pharmaceutical treatment. Elbit Medical Technologies, a subsidiary of Elbit Systems, holds 31.4% of INSIGHTEC’s shares. Following the announcement of the FDA approvment, Ebit Medical’s share surged by more than 15% in the TLV stock exchange.
INSIGHTEC’s Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity.
Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life.
This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.
INSIGHTEC is an Israeli MR-guided Focused Ultrasound (MRgFUS) company Founded in 1999. The company develops and distributes the Exablate platform which provides non-invasive treatments for a variety of oncology and gynecology indications.
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