Varian is the first and only linear accelerator manufacturer in the world to receive FDA 510(k) clearance, CE Mark, and Health Canada medical device license approval for its Edge radiosurgery and TrueBeam systems to treat medically refractory essential tremor.
Essential tremor is a progressive neurological disorder characterized by involuntary motor tremors that can take many forms, but primarily present as rhythmic shaking, most often in the upper limbs and extremities.1,2 While not life-threatening, these tremors can present a serious disability for affected individuals and can make daily tasks extremely difficult.1,2,3 It is estimated that nearly 10 million Americans are affected by essential tremors, and this disease has the potential to be genetically passed to children.4,5
“People with advanced essential tremor can often become completely 100% caregiver dependent. They can get to the point where they can’t even pick up their own glass of water to hydrate themselves. They can’t cut their food. Some become dependent on someone to feed them, to clothe them, to bathe them. This is a particularly cruel disease in that it leaves people with all of their mental faculties, but sometimes completely dependent on caregiver support,” said Evan Thomas, MD, PhD, Chief Medical Officer & Medical Director, Renaissance Institute of Precision Oncology & Radiosurgery, in Winter Park, Florida.
For up to 50% of patients with essential tremor, first-line oral medications are not enough to alleviate symptoms; these cases are designated as medically refractory and require alternative treatments for symptom relief.3,5,6
Surgical procedures like deep brain stimulation (DBS) can be very effective in treating tremors, but are invasive, may require lifetime battery replacements, and many patients either cannot or do not want to undergo the invasive treatment. Other procedural treatments, including focused ultrasound (FUS) and cobalt-based radiosurgery, require a head frame to be attached to the patient’s skull and longer treatment times.1,2,3,6
Now, this condition can be treated using a fast, non-invasive frameless approach on the Edge radiosurgery and TrueBeam systems, which accurately targets the area of the brain involved in the patient’s tremor. Securing regulatory clearances for medically refractory essential tremor, most recently the CE mark, gives patients who are suffering the opportunity to be treated with a non-surgical approach, allowing them to quickly return to their lives without the potential side effects from an invasive procedure.
“The Edge radiosurgery system is an excellent system for the treatment of patients with essential tremor through stereotactic radiosurgery (SRS),” said Pantaleo Romanelli, MD, Chief of Neurosurgery & Stereotactic Radiosurgery, Renaissance Institute of Precision Oncology & Radiosurgery. “It is an image-guided system, a frameless system. It is a completely noninvasive procedure and allows a very fast treatment delivery without compromising accuracy.”
Not only does SRS treatment on the Edge or TrueBeam system provide an efficient and comfortable solution for the treatment of their essential tremor, it also aims to allow patients to regain hope in their lives, where it might have been lost.
“The restoration and quality of life comes in a lot of shapes and sizes and forms and fashions, depending on what’s important to patients and what they’ve lost from their essential tremor,” Dr. Thomas said. “There is no doubt that many, many patients will be helped by frameless radiosurgery on the Edge radiosurgery and TrueBeam systems for their tremors in the future.”
The statements by Varian's customers described here are based on results achieved in the customer's unique clinical setting. Because there is no "typical" clinical setting and many variables exist, there is no guarantee that other customers will achieve the same results.
Not available for sale in all markets.
All rights reserved. All trademarks are the property of their respective owners.
- “Essential Tremor.” Mayo Clinic, March 29, 2023
- Louis, Elan D. “Treatment of Medically Refractory Essential Tremor.” New England Journal of Medicine 375, no. 8 (2016): 792–93.
- “Focused Ultrasound Therapy for the Treatment of Medication Refractory Essential Tremor.” Pennmedicine.org, January 31, 2023.
- “Essential Facts about Living with Essential Tremor.” Brain and Life Magazine - Trusted by Neurologists. Accessed July 12, 2023.
- “Essential Tremor: Medlineplus Genetics.” MedlinePlus. Accessed July 12, 2023.
- “Essential Tremor Treatment: Johns Hopkins Neurology and Neurosurgery.” Johns Hopkins Medicine, March 21, 2023.