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“My Visible Shaking Always Embarrassed Me” – Alexandra Lebenthal’s Story

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Learn about ET symptoms and treatments directly from movement disorder neurologists and other medical experts.  It’s free!

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

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INSIGHTEC is pleased to announce that The Blue Cross Blue Shield Association has made a POSITIVE coverage decision related to MR-guided focused ultrasound treatment for medication-refractory in the treatment of Essential Tremor!   Some BCBS plans have already adopted the policy, and it is anticipated that over the next 6 to 12 months additional Blue Cross Blue Shield (BCBS) plans will begin adopting the policy.  The following BCBS plans cover, or will soon cover, Neuravive, the MR-guided focused ultrasound treatment for medication-refractory essential tremor:

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Neurosurgeon, Dr. Michael Kaplitt from Weill Cornell Brain and Spine Center, and neurosurgeon, Dr. Alon Mogilner from New York University Langone Medical Center, discuss essential tremor and the incisionless focused ultrasound treatment for essential tremor.

Dallas, TX
September 15, 2018
Program: 9 a.m. – 12 p.m.
Check-in: 8 a.m.
Sheraton Dallas Hotel by the Galleria

Neuravive, the MR-guided focused ultrasound treatment for medication-refractory essential tremor, is a Medicare covered benefit in 25 states. INSIGHTEC is continuing efforts to increase Medicare coverage so that more patients have access to this procedure.

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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.

It has been said that we only use 10% of our brain. However, with brain scanning technology, we now know we use our entire brain all the time. When you consider the brain is about 3% of our body’s weight and uses 20% of our body’s energy, you can see that our brains are really busy!

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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.

Knowing essential tremor can be hereditary, when Thomas began experiencing similar symptoms in his left hand, he went straight to a neurologist. Soon after he was informed he too had essential tremor.

Early on in treatment it became clear that medication was not working. His neurologist believed the problem could be solved, but he didn’t have a solid plan as to how. One day Thomas got a call from him that changed everything.

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Neurosurgeon, Dr. Vibhor Krishna, and neurologist, Dr. Punit Agrawal from the Ohio State University Wexner Medical Center, discuss essential tremor and the incisionless focused ultrasound treatment for essential tremor.
Sign up now, seating is limited.

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.

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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.

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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.

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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.

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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.

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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.

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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:

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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?

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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.

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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.
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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.

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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!

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An estimated 10 million Americans 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.

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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.

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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.

Essential tremor was getting in the way of my business, my family – my whole life. (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. Click below to download a compiled list of Patient Advocacy and Support Groups.  Please feel free to contact us if you know of additional support groups.

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

I would be remiss if I did not start with a disclaimer – for diagnosis, consult a neurologist specializing in movement disorders.

While most people are familiar with Parkinson’s disease (PD), essential tremor (ET) is much less known, yet actually much more common…8 times more common. Essential tremor is also referred to as benign tremor, familial tremor, or idiopathic tremor.
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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.

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.

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.

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.

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.”

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:

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