Fda Approval Clears Way For Incisionless Brain Surgery As An Effective Non
A non-invasive ultrasound treatment for Parkinson’s disease that was tested in a pivotal trial led by University of Maryland School of Medicine researchers is now more broadly available at the University of Maryland Medical Center . Recent FDA approval of a device used in the procedure effectively opens up access to focused ultrasound beyond clinical trial participation.
The device, called Exablate Neuro and manufactured by Insightec, was approved in late 2021 by the U.S. Food and Drug Administration to treat advanced Parkinson’s disease on one side of the brain. UMMC is one of only several sites in the Mid-Atlantic region with the capabilities and expertise to perform focused ultrasound for Parkinson’s disease and other movement disorders. The procedure requires a multi-disciplinary team, including a neurosurgeon, movement disorder neurologist, and neuroradiologist.
Expanded Indication Includes Medication
byJudy George, Senior Staff Writer, MedPage Today November 5, 2021
The FDA expanded the approval of Exablate Neuro focused ultrasound to treat advanced Parkinson’s disease patients with mobility, rigidity, or dyskinesia symptoms, device maker Insightec announced Wednesday.
With this new indication, Exablate Neuro is approved for unilateral pallidotomy in medication-refractory Parkinson’s patients with moderate to severe motor complications.
The device uses MRI-guided focused ultrasound waves to target and ablate the globus pallidus, requiring no incisions or brain implants. “Movement disorder neurologists now can offer their Parkinson’s patients a less invasive surgical option as part of their treatment plan,” said Paul Fishman, MD, PhD, of the University of Maryland, in a statement.
Exablate Neuro previously was approved to treat medication-refractory essential tremor and tremor-dominant Parkinson’s disease.
Early studies suggested that focused ultrasound subthalamotomy and pallidotomy performed on one side may reduce motor manifestations of Parkinson’s disease. A sham-controlled trial of patients with markedly asymmetric Parkinson’s disease found that focused ultrasound subthalamotomy performed in one hemisphere resulted in improved motor scores at 4 months, but was associated with adverse events including dyskinesias and other neurologic complications.
Who Can Have Mri
MRI-guided focused ultrasound may be a treatment option for people with essential tremor or with Parkinsons disease when hand tremor is the primary symptom and medications have not worked. Patients with essential tremor must be at least 22 years old and patients with tremor-dominant Parkinsons disease must be at least 30 years old to receive this treatment.
MRI-guided focused ultrasound is not suitable for all patients. You may not be eligible if you have:
- Metallic implants such as a pacemaker, neurostimulator, spine or bone fixation device, total joint replacement, metal clips, screws or cochlear implants
- Heart or spine issues that may make it difficult to tolerate the treatment or lie still for about 3 hours
- Extensive scarring on your scalp
- Tumors inside your skull
What is the Neuravive treatment? Neuravive is a new treatment for essential tremor where sound waves are focused through the skull to a target without the need for incisions, brain implants or radiation. It is based on high intensity focused ultrasound guided by MR imaging. During the procedure ultrasound waves pass through the skull and are focused on a specific target in the brain. The temperature at the target rises high enough to create a tiny ablation or burn and provide a therapeutic effect, reducing the hand tremor. The MRI scanner provides images for the physician to clearly see the treatment area and provides images that show changes in temperature at the target.
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Does Medicare Cover Focused Ultrasound For Parkinsons Disease
There is no mention of focused ultrasound for parkinsons disease in the medicare coverage documents. This means that medicare does not cover this treatment.
MRI-guided focused ultrasound is an option for treating patients at Penn Medicine. This medication is intended to reduce dyskinesia in Parkinsons disease patients. Dr. Casey H. Halpern, the departments chief of Stereotactic and Functional Neurosurgery, is a physician at The University of Pennsylvania. By focusing ultrasound on a specific region, it can induce an ablation in the same area that causes tremor and Parkinsons symptoms. Ultrasonic waves are used in the treatment of the brain to generate a distinct thermal lesions without causing damage to surrounding structures. Because we can safely and effectively perform this procedure, we can perform work on extremely delicate areas.
First Hospital Based Focused Ultrasound Incisionless Procedure For Parkinsons & Essential Tremors In The Region Takes Place At Delray Medical Center
Dr. Lloyd Zucker, neurosurgeon and medical director of neurosurgery, completes first case
Delray Beach, FL –Delray Medical Center is now the first hospital in the region to treat a patient with the new MR-guided focused ultrasound by INSIGHTEC. This technology is a scalpel-free treatment for essential tremor and medication-refractory tremor-dominant Parkinsons disease. This device uses sound wave energy to treat brain tissue as the source of the tremor and there is no surgical incision or anesthesia necessary.
I am honored to be able to not only treat the first patient at Delray Medical Center with this new groundbreaking procedure, but the first in any hospital in the region. We are now able to give those who suffer from this disease a chance to get back to living their lives, and pursuing their daily activities, said Dr. Lloyd Zucker, medical director of neurosurgery for Delray Medical Center. We are at an exciting time in medicine when it comes to treating neuro-disorders, and this technology is a game changer for patients who have suffered from Parkinsons disease.
The MR-guided focused ultrasound combines two technologies, magnetic resonance imaging , which pinpoints the exact location in the brain responsible for the tremor, and ultrasound, which precisely delivers over 1,000 highly focused beams of acoustic energy at that exact location without damaging any surrounding brain tissue.
Some of the benefits to this technology include:
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Fus: Principles Of Operation
Similar to light waves, ultrasound waves can be focused using either single element concave transducers or electronically controlled phased arrays, comprised of large numbers of much smaller piezoelectric transducers. By doing so, their energy can be concentrated up to 3 orders or magnitude in to a small ellipsoid volume at the focus, resulting in a high-intensity field. As a result, energy levels typically used in physical therapy with nonfocused transducers are capable of raising the temperature of the tissues within seconds to 60 °C or greater, when focused, to induce denaturation of cell proteins and, ultimately, coagulative necrosis. However, in the intervening tissues the width of the beam is much broader, and so corresponding intensities are lower. As a result, energy absorption is also lower and the deleterious effects of the exposures do not occur .
Government Assistance For Parkinsons Patients
PANFs Parkinsons disease fund assists eligible individuals and families in covering the cost of critical medications with out-of-pocket expenses. As a result, the annual maximum amount available to them is $16,500.
Non-medical Parkinsons care costs an average of $10,000 per year for families. It is estimated that this amount is paid out of pocket or not covered by insurance. Non-medical care, on the other hand, assists you in maintaining your daily activities. This article describes which insurance programs are most commonly used, as well as what other types of financial assistance are available. Parkinsons patients ability to bathe or take care of their oral hygiene is compromised. Food preparation is nearly impossible, feeding oneself is difficult, and assistance is usually required. Because of the sleep challenges that patients with Parkinsons disease face, 24-hour observation is critical to their well-being.
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A New Era For Parkinsons Disease Treatment
A diagnosis of Parkinsons disease no longer automatically portends a future of extremely limited physical capabilities. Thanks to the commitment of researchers like Dr. Eisenberg and Dr. Fishmanand clinical trial participants like Steve Squirestreatment has expanded to include non-invasive options that significantly reduce certain symptoms within minutes and transform the lives of people who had been living with debilitating symptoms, said Bert W. OMalley, MD, President and CEO of the University of Maryland Medical Center.
Our school of medicine researchers have established themselves as world leaders in pioneering MRI-guided focused ultrasound for many devastating brain diseases, including Parkinsons and essential tremors, said E. Albert Reece, MD, PhD, MBA, Executive Vice President for Medical Affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. The stellar work of Dr. Eisenberg and Dr. Fishman has led to a new era in which this breakthrough modality has now become the standard of care for patients looking for less invasive treatments for their symptoms.
Hifu Facelift Treatment Pros And Cons: Why Is It Getting Popular
For those who do not know, HIFU stands for High-Intensity Focused Ultrasound, an advanced cosmetic technology that significantly tightens and lifts several areas of the face.
It also reduces signs of aging and improves the tone of the skin in a single session.
HIFU Facelift is a long-lasting, non-surgical, non-invasive treatment that uses ultrasound energy to tighten and lift the skin.
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What Are The Benefits Of Medicare
What services are covered by Medicare? Beneficiaries of Medicare have access to a variety of services, including doctor appointments, hospital stays, medical tests and equipment, and home health care. Beneficiaries may also receive coverage for care related to chronic conditions such as diabetes and heart disease. What are Medicare limitations? What would make it a burden? There are some limitations to Medicare. Nursing homes and long-term care facilities, for example, are not covered. It does not cover the cost of any prescription drugs. What is medicare? Medicare provides a number of benefits, including access to preventative care, such as screenings for cancer and heart disease, and the treatment of chronic conditions. Medicare also provides assistance with the cost of prescription drugs and other medical care for those who qualify. How can I get a clear answer on whether I am covered by Medicare? If you are unsure if you are covered by Medicare, you can contact the Medicare call center at 1-800-633-4327 . Here, you can learn whether you are eligible for Medicare coverage, as well as get information on how to enroll in the program.
Fda Approves Focused Ultrasound For Parkinsons Symptoms
Jeff Elias, MD, pioneered the use of focused ultrasound for the treatment of essential tremor and Parkinson’s disease.
The federal Food and Drug Administration has approved an incisionless form of brain surgery to treat advanced Parkinsons disease after successful testing at the School of Medicine and other sites.
The authorization allows the use of Insightecs Exablate Neuro focused ultrasound device to treat problems with mobility, rigidity and involuntary movements known as dyskinesias that are common in Parkinsons. UVA is one of only 37 medical centers in the country with the capacity to offer this minimally invasive treatment, according to the Charlottesville-based Focused Ultrasound Foundation, a longtime supporter of UVAs pioneering research into the many potential applications of the technology.
Prior to the approval, available treatments for the Parkinsons symptoms included drugs, which not all patients respond to, and invasive deep-brain surgeries. Focused ultrasound, in comparison, does not require incisions or cutting into the skull. Instead, the technology focuses sound waves inside the brain to interrupt faulty brain circuits, much like a magnifying glass can focus light to create heat. During the focused ultrasound procedure, doctors use magnetic-resonance imaging to peer inside the brain in real-time before making any permanent changes, helping ensure patients get the best possible outcomes.
Also Check: Treatment Of Dyskinesia In Parkinson’s Disease
Why Choose Us For Mri
The University of Kansas Health System is the only medical center in the region that provides MRI-guided focused ultrasound to treat essential tremor and Parkinsons disease with hand tremor as the primary symptom. Our health system is 1 of only 47 medical centers around the world that the Parkinsons Foundation has designated a Center of Excellence for Parkinsons disease care.
When you choose The University of Kansas Health System for MRI-guided focused ultrasound, you will be cared for by a team of neurologists who are specialists in their fields. A dedicated nurse navigator will help you as you go through the processes needed leading up to your treatment. Our neurology and neurosurgery program is nationally ranked by U.S. News and World Report.
Mr Guided Focused Ultrasound
An Incisionless Treatment for Essential TremorMR Guided Focused Ultrasound is a treatment for essential tremor or tremor-dominant Parkinsons disease patients who have not responded to medication. Requiring no incisions, permanent implants, or radiation exposure, it uses focused sound waves guided by MRI to pass through skin, muscle, fat, and bone to treat deep in the brain.
How Does the Procedure Work?During the procedure, ultrasound waves are focused on a small point in the brainpassing safely through the skull without the need for an incision. The temperature at the target rises high enough to create a microscopic ablation or burn, providing a therapeutic effect.
Where Does the Procedure Take Place?The whole procedure is conducted inside of an MRI scanner at Mount Sinai West. Serving as the eyes of the treatment, the MRI enables your physician to plan, guide, and precisely target the area for treatment. It also acts like a thermometer, providing continuous temperature monitoring to verify that only the targeted tissue is destroyed.
Will My Tremors Go Away?Based on the current scientific literature, most patients get a 50 to 80 percent reduction in tremor maintained for up to three years.
Is This Treatment Right for Me?To determine if MR Guided Focused Ultrasound treatment is right for you, please make an appointment with the Center for Neuromodulation for a consultation.
For more information, please reach out to Tiffany Arnold, or 212-523-8130.
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The Power Of Focused Ultrasound
It was a decade ago that Elias treated his first clinical trial volunteer with essential tremor, a common movement disorder, using the focused ultrasound technology. Since then, Elias and his neurology collaborator Binit Shah, MD, have been leaders in developing MRI-guided focused ultrasound as a commercially approved procedure. UVAs work, for example, paved the way for the federal Food and Drug Administration to approve the technology to treat essential tremor in 2018, and the agency has now expanded that approval to include other common Parkinsons symptoms, including rigidity and involuntary movements, for appropriate patients.
Neal F. Kassell, MD, chairman of the Focused Ultrasound Foundation, hailed the FDAs decision. The Foundation has long considered the brain to be a vanguard target for focused ultrasound, and this ruling by the FDA is a huge win for both providers and patients, said Kassell, a former UVA neurosurgeon.
Elias, too, is excited about what the approval could mean for Parkinsons patients. This ultrasound technology is obviously very popular with patients because it can be performed on an outpatient basis and without any incision, he said. It is still very early stage for a new procedure, so experience and technological advances will increase the safety and effectiveness.
Delray Medical Center Is First Hospital In Region Offering New Incisionless Treatment Option For Parkinsons & Essential Tremor Patients
Delray Beach, FL Delray Medical Center is the first hospital in the region to offer a new scalpel-free treatment for essential tremor and medication-refractory tremor-dominant Parkinsons disease. MR-guided focused ultrasound by INSIGHTEC, uses sound wave energy to treat brain tissue at the source of the tremor. No surgical incision or anesthesia is necessary, and patients may experience immediate and significant reduction in their hand tremors, giving them a chance to get back to their daily activities.
This technology is a game changer in our community and for those seeking the very latest in cutting edge technology for neurologic care of Parkinsons disease, said Dr. Lloyd Zucker, chief of neurosurgery at Delray Medical Center. The future is bright for those who may be stricken with this neurological disease, as we can care for these patients with this new innovative solution to treat tremors.
MR-guided focused ultrasound combines two technologies, magnetic resonance imaging , which pinpoints the exact location in the brain responsible for the tremor, and ultrasound, which precisely delivers over 1,000 highly focused beams of acoustic energy at that exact location without damaging any surrounding brain tissue.
Some of the benefits to this technology include:
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Individuals With Pd At Risk For Nursing Home Placement
In clinical practice, a person with PD is frequently housed in a nursing home when nonmotor symptoms such as hallucinations, psychosis, and dementia, as well as motor symptoms progress to the point where they interfere with When an individual is diagnosed with Parkinsons disease, their long-term progess is heavily influenced by their stage of the disease, their overall health, and their age. Almost all people suffering from Parkinsons disease have a normal or near-normal life expectancy. Despite the fact that Parkinsons disease is still a serious and disabling illness, people who suffer from it should always consult with their healthcare providers about how to manage their symptoms and take care of their health.
Are You A Candidate
To be eligible for this treatment, you must answer yes to all of the following questions:
- Have you been diagnosed with essential tremor?
- Have you tried at least two medications for your tremor?
- Does your tremor affect your quality of life?
- Would you be comfortable lying still in an MRI scanner for two to three hours?
- Are you over the age of 22?
If you meet all five criteria, you may be a candidate for treatment with focused ultrasound. Please have your doctor fax or email us a referral and a copy of your insurance card. For more information, feel free to give us a call.
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Research Into Focused Ultrasound
Ongoing research on focused ultrasound for Parkinsons is evaluating the procedure in different brain areas affected by Parkinsons, such as the subthalamic nucleus and the pallidothalamic tract. At the same time, scientists are looking at the possible benefits and safety of both-sided FUS in different targets as well as the best practices for performing this procedure.
Researchers also are studying how ultrasound could help other Parkinsons treatments, such as antibodies against alpha-synuclein or gene therapies, get into the brain more easily and efficiently by temporarily opening the brains protective barrier.