xxx

Download 3-Year Clinical Study Data

Sort By

In the beginning of 2020, Insightec announced the first Treatment Center in Latin America when Red de Salud UC CHRISTUS in Chile started treating patients with Essential Tremor and Tremor-dominant Parkinson’s Disease. Then COVID-19 changed the world and Chile has been focused on managing a major health crisis. As soon as the restriction on elective procedures was lifted in early September, the Focused Ultrasound team at UC CHRISTUS restarted their Incisionless Neurosurgery program, with a clear objective to keep patients safe.
(more…)

John is an artist. He has been for his entire life. It’s part of his identity. What would you do if what makes you uniquely you was being taken away from you?
(more…)

Living better, living longer

Across the globe there are many cultural perspectives on how to, as Spock might say, live long and prosper. Two cultures that have been able to show longevity are the people of Okinawa, Japan and Sardinia, Italy. The inhabitants of these two areas have the highest rate of centenarians in the world (22 centenarians/100,000 inhabitants). These are locations referred to as Blue Zones­–a demographic and/or geographic area in the world with an oversize concentration of centenarians and supercentenarians. [1]

(more…)

Guest blog by Pravin Khemani, MD, Swedish Neuroscience Specialists – Movement Disorders

I recently conducted a telemedicine appointment for a patient living with a movement disorder. I’ve been doing more of these lately. As the video feed began, the camera appeared shaky, and I had trouble understanding the patient’s garbled voice. I saw trees in the background, children playing ball and it seemed that the patient was taking a walk in the park while conducting his appointment!

(more…)

Beverly McGowan’s story is one of perseverance through relaxation.
(more…)

It is exciting to work at a company that has developed truly ground-breaking technology. What makes every day inspiring is the realization that our technology can help people live active and productive lives.
(more…)

Effective July 12 2020 Neuravive, the MR-guided focused ultrasound treatment for medication-refractory essential tremor, is a Medicare covered benefit in all 50 states.
(more…)

Guest blog by Dr. Aaron Bond, Semmes Murphey Clinic

I have been involved with focused ultrasound since the early days of the first research cases. At that time, I was a resident at the University of Virginia and Dr. Jeffrey Elias was the leading investigator in an Insightec-sponsored pilot study to evaluate MR-guided focused ultrasound to treat essential tremor.

(more…)

INSIGHTEC is pleased to announce that The Blue Cross Blue Shield Association has made another POSITIVE coverage decision for MR-guided focused ultrasound treatment for medication-refractory Essential Tremor.

(more…)

When I am nervous, my hands shake and my palms get sweaty. My heart beats faster and my stomach acid churns like it’s trying to make butter. Sometimes, my head wobbles like I’m a bobblehead doll. Of those symptoms, the only one other people can see is the shaking.
(more…)

There could be many reasons why you are seeking out medical information on essential tremor. You may want to see if you have related symptoms, you may have been diagnosed with ET and want to learn more, or perhaps a friend or a loved one is experiencing either of these scenarios and you want to help.
(more…)

I recently spoke with Andrew – an INSIGHTEC Clinical Account Manager (CAM) – about the flow of an essential tremor treatment day through his eyes. An INSIGHTEC Clinical Account Manager (CAM) helps Treatment Centers offering focused ultrasound run an effective and efficient service line.
(more…)

People living with tremor from Essential Tremor (ET) and tremor-dominant Parkinson’s Disease (PD) can feel overwhelmed by the challenges they face on a daily basis. Fortunately, there are organizations working tirelessly to support these patient communities.

(more…)

“Jab! switch to a cross, follow up with a hook, end with an upper cut. I want to hear you breathing after each punch! Do it again!”

(more…)

Marcello, Franco and Antonello, three brothers aged 54, 57 and 60, had been suffering from the same familial disease for more than thirty years – Essential tremor. All three decided to have Magnetic Resonance-guided Focused Ultrasound treatment to try and relieve the tremor that had been disrupting their normal life.

(more…)

When I reached out to Gary, he was recoating the deck at his home in Oregon. This is just one of the projects he would have struggled to do until his recent focused ultrasound treatment for essential tremor.

(more…)

A university professor visited Nanin to inquire about Zen.
Nanin served tea. He poured his visitor’s cup full, and then kept on pouring.
The professor watched the overflow until he no longer could restrain himself. “It is overfull. No more will go in!”
“Like this cup,” Nanin said, “you are full of your own opinions and speculations.  How can I show you Zen unless you first empty your cup?”

(more…)

“On the golf course, everything is starting to click for me!” said my father at dinner. “My knees, my elbows, my neck…”

Getting old can be rough, and humor is one way to help get through life’s day-to-day challenges. There is also scientific support for the fact that socializing with others [1] is a part of a trifecta of strategies to help maintain quality of life and which includes:
1. Exercising your body,
2. Exercising your mind, and
3. Socializing with family and friends

(more…)

Press play below to listen to Beverly McGowan’s journey to tremor relief:

Beverly McGowan is a nurse practitioner who has worked with patients both at the V.A. and with Medicare for more than fifteen years. This work continually presents her with opportunities to provide compassionate care and to educate people regarding their health, including evaluating their medications and ensuring the best quality of life for one and all.

(more…)

Fixing things around the house, playing golf, painting or dinner with friends may allow us to balance stress in our lives. However, these activities may add anxiety and frustration to the daily challenges of people living with essential tremor.

(more…)

Last month, we connected with Health Educator Lisett to learn about  INSIGHTEC’s Tremor Program Services, which provides education to patients and caregivers on essential tremor as well as FDA-approved treatment options, with an emphasis on INSIGHTEC’s Neuravive treatment. This month, I would like to introduce you to Yasmina, another Educator at INSIGHTEC.

(more…)

Press play below to listen to Bob’s journey to tremor relief.

 

Bob Walker hails from Alabama. About 15 years ago, he noticed the shaking when he tried to do daily activities like drinking and writing. After visiting a neurologist, he was diagnosed with essential tremor and started taking medications. Unfortunately, they did not work for him, and his hand tremor got progressively worse.

(more…)

Let’s face it—tremors can be really embarrassing when they happen in public. In a world that craves normalcy, tremors may be perceived as abnormal behavior. No one knows this better than people who suffer from tremor-related movement disorders, such as Essential Tremor (ET) and tremor-dominant Parkinson’s Disease (PD).

(more…)

Today I attended a celebration to mark the 100th patient to be treated at Rambam Hospital in Haifa, Israel using Focused Ultrasound surgery for essential tremor or tremor from tremor-dominant Parkinson‘s disease.

The event was hosted by the Israeli company INSIGHTEC, which developed and manufactures the medical device used to perform the incisionless surgery, and which is in use in over 60 centres worldwide.
(more…)

An interview with Hanane Chabainou, CRNP

When patients go to a neurosurgeon, they are often very anxious about what to expect from surgery. Will it be painful? What are the potential side effects? What tests are required? What is the recovery period? As a Nurse Practitioner at a Parkinson’s Disease and Movement Disorders Center, Hanane Chaibainou, CRNP describes the beautiful moments she experiences in her role providing answers to ease patient and caregiver anxiety about neurosurgical procedures.

I spoke with Hanane about her experience working alongside a neurosurgery team with procedures such as MRI-guided focused ultrasound to treat tremors in patients with essential tremor and tremor-dominant Parkinson’s disease.
(more…)

Who has a brain procedure and then asks her girlfriend who accompanied her, “What do you want to do now?” Karen Dopher. Just two months ago, she underwent Neuravive focused ultrasound to treat her essential tremor. That very same day, she went on a 2-mile hike and went out to dinner. Here she is at the beach the very next day.
(more…)

When you or your loved one has been diagnosed with an illness, multiple questions begin to run through your mind. What exactly does my diagnosis mean? What treatments are available? What should I expect during the treatment? Are there treatment centers near me?

While searching the internet for answers to these questions and many more, aren’t there times you wish you could pick up the phone and speak to someone directly instead of asking Alexa? INSIGHTEC, an innovative, forward-thinking company established Tremor Program Services for that precise purpose. Tremor Program Services is designed to increase awareness and provide education to patients and caregivers on essential tremor and FDA-approved treatment options, with a focus on Neuravive. Neuravive is an incisionless treatment performed using the FDA-approved Exablate Neuro focused ultrasound device.
(more…)

The Doctors on CBS recently aired a segment focused on Jodi and her story living with essential tremor for more than a decade.

(more…)

Bats! That’s right. We owe a debt a gratitude to bats because without them, we may not have ultrasound technology. In 1794, it was first discovered that bats send calls (i.e., sounds) out to the environment to locate and identify objects in their path.

(more…)

Meet Paul Flick. He is 58 years old. Originally from New Jersey, he now resides in Florida with his wife after moving a mere 23 times. He received his BS in Information Systems from Drexel and is employed as a Systems Analyst. His travels and interactions with people from many cultures have made him understand that  what he does every day is “resolve problems for people.”

When Paul was younger, he used to visit his grandmother. While he noticed her hand tremors, he chalked it up to her elderly age. Then, in his late 30’s, they began holding out their hands to compare whose tremor was worse that day.

(more…)

One day at lunch with an internist, Peter Muller had a Eureka moment. He had lived the last 33 years frustrated by not knowing why he could not control shaking in his arm, and suddenly he was given a clue. The internist told him that he may have Essential Tremor (ET). On a visit to a movement disorder specialist the potential diagnosis became a reality.

(more…)

This month I was fortunate to interview Donna P. to learn about her experience as a research subject in the Neuravive focused ultrasound clinical trial for ET.

Donna brings an enthusiasm for life in everything she does, whether that is cooking her favorite delicacies or playing games with her grandchildren. This is why when the opportunity came for her to do something about her essential tremor (ET), she took the bull by the horns.

Donna has lived with essential tremor for over 30 years. While medications worked for her early on, over time their effectiveness wore off. Her neurologist wanted to do more to ease her suffering, but the options were limited.

(more…)

While essential tremor (ET) is the most common form of tremor in adults, each case can be very different. Yet even with this variability, a physician diagnosing ET focuses on identifying symptoms that are consistently seen across people who suffer from it.

Neurologists specializing in movement disorders have a tool kit they use to identify and assess the severity of ET. I sat down with Paul S. Fishman M.D., Ph.D., a Professor of Neurology, Adjunct Professor of Pharmacology and Neurobiology at the University of Maryland School of Medicine, and Chief of Neurology for the Maryland VA Health Care System, to learn more about how ET is diagnosed. Dr. Fishman also spoke about how practical it is to use telemedicine to perform an exam without having the patient travel to the hospital.

(more…)

Early in December of 2018, I had the pleasure to attend the play Swimming with Kate–one woman’s deep dive with essential tremor (ET). MaryCae Asay wrote and performed the play about her life with ET.

(more…)

Thanksgiving and Christmas Day are two of those many food-focused holidays I would rather avoid. And like many suffering from ET, I would give anything to get through one family gathering without worrying over how I will get my food to my mouth without spilling, dropping, or stumbling around.

(more…)

We are all doing it – going straight to WebMD instead of the real MD. According to a recent study, more than one-third of U.S. adults use the Internet to self-diagnose their medical condition. However, less than half — 41 percent — say that a doctor confirmed the diagnosis they made from online research.1

(more…)

According to scientists, we have more knowledge about stars than we have about the human brain. Our brain may only weigh 3 pounds, but it is complex and mysterious. When you consider that we have around 86 billion neurons1 (formerly believed to be 100 billion) that create more than 100,000 chemical reactions in the brain every second, it makes sense that our understanding of the brain continues to evolve over time.

(more…)

Thomas took great pride in playing darts. His father had schooled him well in this family tradition that went back decades. However, when his father reached his 60’s, he was diagnosed with essential tremor. At that point, his hand shook so much that he could no longer throw the darts with precision.

(more…)

Billy Williams always led an active, happy life defined by work, hobbies and family. After four years in the Air Force, Billy went to work at Western Union. After 28 years, he returned to his military roots and worked in the communications department of the Joint Chiefs of Staff at the Pentagon for more than a decade. In the midst of all those satisfying work years, Billy and his wife raised two children in Winchester, Vermont.

Billy’s essential tremor started about 12 years ago while he was still working at the Pentagon. The tremors affected his hands, though more in the right than the left. Since he’s right-handed, the tremors affected all of his activity, writing especially, but also eating and even teeing up a golf ball. (more…)

Essential Tremor (ET) affects everyone differently. But for nearly everyone with ET, common everyday tasks can be challenging. Writing, eating, drinking and dressing are functions most people take for granted. And when these activities are difficult, it can set the tone for frustration or worse, lead to a life devoid of much social or public interaction.

Fortunately, there are techniques as well as tools that can take those tasks from daunting to manageable. Occupational therapist Julia Wood, who specializes in movement disorders of all types, combines practical mental and physical approaches every day with her patients at Pennsylvania Hospital’s Penn Therapy & Fitness.

(more…)

At INSIGHTEC, we make every effort to listen to patients, whether that is reading and responding to daily comments on Facebook or talking face-to-face at patient forums. Whether Medicare covers the Neuravive treatment is one of the questions that we receive very often, and now we have some good news to share with all of you.

 

MR-guided focused ultrasound (Neuravive treatment) is now covered in 10 states. Additionally, on July 1, coverage will expand to 6 additional states. Additional Medicare Administrative Contractors (MAC) have issued positive Draft Local Coverage Determinations (LCDs) with potential to further expand Medicare coverage to a total of 38 states.

(more…)

Western medicine is increasingly recognizing the importance of a positive mental attitude on overall health. This is especially true in the essential tremor community. Symptoms that can range from embarrassing to annoying to debilitating can pose both physical and emotional challenges in daily life. How do you cope with your essential tremor? A positive mental outlook can be enormously helpful.

(more…)

For my entire life, I’ve lived with a condition called Essential Tremor, a movement disorder that caused my hands to shake. As a child, I had terrible penmanship that never improved. My teachers all thought that I just couldn’t write well. Little did they know that I had a condition that prevented me from writing fluidly. Even though I was a good athlete as a kid, I was nicknamed “Shaker” by my teammates. I learned to live with my tremor, and never really thought too much of it until I was in my early fifties. The condition got worse as I got older, and soon impacted every facet of my daily life.

(more…)

While MR-guided focused ultrasound ablation was dramatized on Grey’s Anatomy, the technology is real and being used to treat patients with essential tremor that has not responded to medication. (more…)

INSIGHTEC had the opportunity and honor to take part in a very successful Essential Tremor Education Forum organized by the International Essential Tremor Foundation (IETF) in Philadelphia, Pennsylvania on March 10, 2018.

(more…)

Even though ET is 8 times more common than Parkinson’s disease, many people have never heard of essential tremor and don’t know what it is.  INSIGHTEC joins the network of organizations that focus on educating the public about ET with the #DoYouKnowET Facebook campaign.

(more…)

Neuravive is an incisionless treatment that uses ultrasound beams to treat medication refractory hand tremor. The treatment is performed in an MRI scanner.

Here is a list of steps that will help you navigate your way to the Neuravive Treatment:

(more…)

Lights. Camera. Action.

Every year, Las Vegas turns into a mecca for innovation.  The Consumer Electronics Show (CES) is the world’s gathering place for all those who thrive on the business of consumer technologies. Tech companies from around the world gather to show off the latest tech that is poised to completely change our lives – from self-driving cars to Artificial Intelligence (AI), smart robots to smart cities. This year, focused ultrasound took center stage. But to be honest, what was a medical technology doing at a consumer show?

(more…)

Focused ultrasound gave me back my life – it can for you, too.

It is said that our bodies are the temples of the mind, but if not, they’re certainly our vessels. When I retired in 1994, I could hardly climb two flights of stairs. But now, at 79 years old, and after earning three world records in swimming in my seventh decade, I’m appreciating all that life brings. Age, after all, is just a number.

(more…)

In my day job, I’m VP of Marketing at INSIGHTEC. What many people at work don’t know about me is that I’m a Knitter. I spell that with a capital K because knitting for me is a way of life. It has taught me so much about things that have nothing to do with yarn and needles – that meeting life goals is a marathon not a sprint, that small actions can have big impact and affect change, that success requires planning but also creativity. With each stitch, I devise strategies, solve problems and calm my craving for immediate results.
(more…)

National Family Caregivers Month is celebrated every November.  It is a month dedicated to recognizing and honoring family caregivers.

Taking a month to celebrate their labors of love helps to raise awareness about their issues and struggles, while offering some support – letting them know that they are not alone.

(more…)

Read More
Blog
14
November

In light of National Caregivers Month, this month’s blog features caregiver, Cathy Ley.

 

Cathy Ley’s Story:

My husband and I have been married for 33 years. The past year has been one of the best. That’s because he was in a clinical trial at Swedish Medical Center in Seattle one year ago. This trial was a treatment for his Essential Tremor using focused ultrasound and it was a complete success!

(more…)

Approximately 41 million patients worldwide1 are living with essential tremor and the debilitating symptoms that can make everyday tasks feel almost impossible. With more and more apps available, we have listed some of the best out there on iOS and Android, which can help with anything from keeping a record of your tremor to improving the layout of your keyboard.

(more…)

Talking with your doctor builds trust and leads to better results, quality, safety, and satisfaction.  Your health is a team effort and you play an important role in this dynamic. One of the best ways to communicate with your doctor is by asking questions. It is important to prepare a list questions before an appointment, (1) because time is usually limited during medical appointments and (2) many people may feel intimidated by questioning their doctor’s authority, so a prepared list will help build confidence.  (more…)

The positive impact of Focused Ultrasound technology in treating essential tremor.

Living with uncontrollable shaking since I was 3 – I’m now 53 — I struggled to pour drinks, eat food, shake hands, write notes and swipe my subway MetroCard my whole life. I was painfully self-conscious of the visible shaking of my arms and hands all through school and adolescence, dating and graduating. Even when I became a successful CEO in the investment community, that shame continued during the many professional and social events I attended. It’s amazing I could keep the condition a secret for most of my life.

(more…)

How Neuravive’s incisionless treatment for essential-tremor improved my quality of life

 

I have lived my whole life in a small town of Quitman, Georgia. My wife, Cathy, and I have two grown children, Rachel and Thomas, and four grandchildren, Zack, Cody, Kinsey and Austin. I’m 58 years old. I make my living in electronics repair, fixing TVs, radios, stereos and other home electronics. My brother, Billy, is my partner in the business. Our grandfather started the radio repair business in the 1930’s when radios first came out and it’s been our family business ever since.

(more…)

Many people find peer support a helpful tool that can aid in managing their condition. There are a variety of patient advocacy groups and patient support groups that offer support for patients and their family members.
(more…)

Working at INSIGHTEC, I became aware of how daily tasks, such as holding a glass or writing with a pen, can be nearly impossible for essential tremor patients.  What I didn’t really internalize was the extent of the emotional impact that essential tremor can have on patients’ lives.  Recently, I had the honor to have a conversation with Diann Shaddox, founder of the Diann Shaddox Foundation for Essential Tremor.  I was incredibly moved by her story as she spoke of the frustration in coping with this disorder.
(more…)

Dr. William Ondo shares 10 symptoms that distinguish between tremors from essential tremor and Parkinson’s disease.

(more…)

Neurosurgery department invites you to a free seminar

UCLA movement disorders neurosurgeons will discuss treatment options for the surgical management of tremor including deep brain stimulation and focused ultrasound. Topics include: Coping strategies, Surgical therapies – deep brain stimulation (DBS), noninvasive treatments, focused ultrasound, radiosurgery

Speakers:

Nader Pouratian, MD, PhD
UCLA Neurosurgery Director
Neurosurgical Movement Disorders Program

Ausaf A. Bari, MD, PhD
Assistant Professor
UCLA Department of Neurosurgery

Date: Saturday, March 7th

Time:
Registration 9:00-9:30am
Presentation and Q&A: 9:30am-noon

Location:
Suncoast Hotel and Casino
9090 Alta Drive
Las Vegas, NV 89145

RSVP by calling (310) 571-5741 or emailing ucla.tremor@gmail.com

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, announced today that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication.

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.

“Results of this study show that Exablate Neuro is safe and effective for treating essential tremor. Finding the most effective way to manage tremor symptoms is crucial for patients. The patients we have treated show immediate tremor control, allowing them to regain ability to perform daily tasks such as eating and writing,” commented Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and Principal Investigator in the study.

Earlier this year, Exablate was also approved by Health Canada for essential tremor.

“This newly FDA approved device provides a new treatment option without some of the complications associated with surgery to offer patients with essential tremor. Furthermore, it holds promise for a range of neurosurgical procedures,” noted Andres Lozano, MD, Dan Family Professor and Chairman of Neurosurgery at Toronto Western Hospital, University of Toronto and Investigator in the study.

“I am confident that we have arrived at a tipping point for non-invasive medical treatment. Focused ultrasound has the unique ability to precisely ablate target tissue deep within the body. With Exablate Neuro, INSIGHTEC expands its Exablate product line with a system that signifies a new era for functional neurosurgery,” stated Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board.

NON-INVASIVE AND SAFE PROCEDURE ALLOWS PATIENTS TO QUICKLY RETURN TO NORMAL ACTIVITY

INSIGHTEC, the leader in MR-guided Focused Ultrasound (MRgFUS) therapy, today announced that the New England Journal of Medicine (NEJM) has published the results of a pivotal study of their Exablate Neuro system for the non-invasive treatment of essential tremor (ET). The study met its primary endpoint with patients treated with Exablate Neuro demonstrating a clinically significant 47% improvement in a composite tremor score at three months as compared to no change in the sham cohort.

The NEJM article presents findings from an FDA study designed to evaluate the safety and efficacy of Exablate Neuro for the treatment of essential tremor in subjects for whom medications were not effective. Results of this randomized, double-blind, multi-center clinical study were submitted as the key data resulting in FDA approval of INSIGHTEC’s Exablate Neuro as the first focused ultrasound device to treat essential tremor.

“MRI imaging and thermometry provide a high level of control during focused ultrasound thalamotomy. Importantly, before treatment, adjustments can be made based on intraoperative imaging and clinical feedback from the patient, contributing to a safe procedure,” said Dr. W. Jeffrey Elias, Director of Stereotactic and Functional Neurosurgery at the University of Virginia and primary author of the NEJM paper.

Seventy six 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 transmission of ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment.

“The robust study findings showed that focused ultrasound safely improved hand tremor in patients with refractory tremor by precisely targeting and ablating deep brain tissue without surgical incisions, thus minimizing risk of infection, bleeding or other complications sometimes seen in surgical operations.” said Dr. William G. Ondo, Tremor Research Group President.

The primary endpoint combined the Clinical Rating Scale for Tremor (CRST) Part-A and Part-B, an 8-element measure of tremor and hand function. For the Exablate Neuro treatment group, a mean score of 18.1±4.8 at baseline was reduced to 9.6±5.1 at 3 months (47% change), while the sham group showed no change, demonstrating a highly statistically significant (p<0.001) difference between groups.

Patients in the treatment group showed a 63.4% reduction in tremor amplitude alone (CRST A) which was maintained at one year follow up. Additionally, the total disability score (CRST part C) improved by 68% and patient assessment of their quality of life (QUEST) improved by 51% overall at 12 months for treated patients. Most adverse events were transient, minimal or unrelated to the Exablate Neuro procedure.

“We are pleased with the results of this pivotal study that addresses a major issue for the five million Americans and millions more worldwide that suffer from this debilitating disease,” said Maurice R. Ferré MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “With this positive data and the subsequent FDA approval of the Exablate Neuro system, patients can be treated and return to performing everyday tasks with greater ease and enjoy a better quality of life.”

The sites participating in the clinical study included: University of Virginia, Stanford University Medical Center, University of Maryland, Brigham and Women’s Hospital, Swedish Medical Center, Yonsei University Medical Center (South Korea), Sunnybrook Health Sciences Centre (Canada) and Tokyo Women’s Medical University (Japan).

Funding for the study was provided by the Focused Ultrasound Foundation and BIRD (US-Israel Binational Industry R&D) and INSIGHTEC.
Exablate Neuro has now received FDA, Health Canada and Korean approval for essential tremor and CE mark in Europe for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain.

For the complete NEJM study click here

CNBC features a extraordinary interview about the benefits of the Exablate Neuro Treatment with Alexandra Lebenthal, Lebenthal Holdings president and CEO, and Dr. Michael Kaplitt, Weill Cornell Medicine department of neurological surgery vice-chairman for research.

For the full interview, CLICK HERE.

Living in Carmel, golf was a passion for Joe Cusenza once he was actually able to tee off.  “Because literally I could not hold the ball steady enough to keep it on the tee,” explains Cusenza.

Joe suffered from a condition called essential tremor, which effects an estimated 10-million Americans. His right hand shook so badly, he could barely write a legible sentence. Stanford neurologist Veronica Santini, M.D.,M.A., says the normal treatments range from drugs, which can lose effectiveness over time, all the way up to major surgery.

“For instance the other therapies we have require a big brain operation, where we open the skull and we enter the brain tissue,” says Dr. Santini.

Instead the Stanford team turned to a newly approved procedure. It combines the imaging power of MRI with heat generated by a special ultrasound. With a halo-like device attached to his skull, Joe is placed in the MRI. Over the course of the treatment, doctors beam sound waves into a precise area inside Joe’s brain. That resulting heat destroys the nerve cells causing the tremors.

 

For the full story CLICK HERE.

Doctors in London have used sound waves to successfully operate deep inside the brain.  They treated a man from Cornwall who suffered from uncontrollable tremors in his right hand.

Selwyn Lucas, who is 52, can now hold his hand steady and said he felt “fantastic”.

The team at St Mary’s hospital used MRI guided focused ultrasound to destroy tissue causing mistimed electrical signals to be sent to muscles.

The BBC was given exclusive access to the treatment, which was performed in the imaging department rather than operating theatres, and did not involve surgeons.

For the full story CLICK HERE.

Neurosurgeon Dr. Michael Kaplitt and patient Alexandra Lebenthal discuss new advances in treating Essential Tremor, a nerve disorder.

Alexandra Lebenthal, the president and CEO of municipal bond company Lebenthal & Co., has undergone the Exablate Neuro treatment after  living with essential tremor since she was 3 years old. It made daily tasks like taking a sip of coffee a much more complicated task. But it’s not something she talked about much, out of embarrassment.

Don’t miss this compelling interview, where Alexandra describes the procedure as “life changing.” яндекс

CLICK HERE TO WATCH

Seattle local news station, King 5, featured INSIGHTEC’S focused ultrasound treatment for Essential Tremor.  The Essential Tremor patient, Greg, came in from Georgia to receive the treatment at Swedish. He flew across the country to try and find a cure for a problem that he’s experience for more than 20 years.

“The last two years it’s gotten worse to the point where I can’t even sign my own name and you recognize what it says,” Greg said.  Greg works an electronic technician by trade and it’s impaired his ability to do the job.“His tremor has basically ended his career,” Dr. Gwinn said.

For full coverage: CLICK HERE.

Sharon Samuels was a teenager when she was first diagnosed with essential tremor. Over the years her condition worsened, until a new therapy came along to help improve her brain’s motor circuit.

For the full article and video on her story click here:

Font Resize