Varian TrueBeam and Edge Radiosurgery Systems Receive FDA 510(k) Clearance for Treatment of Medically Refractory Essential Tremors with Stereotactic Radiosurgery

Varian has received 510(k) clearance from the FDA for the use of TrueBeam and Edge systems to treat medically refractory essential tremors with stereotactic radiosurgery.

For up to 50% of patients with essential tremors, first-line oral medications are not enough to alleviate symptoms; these cases are designated as medically refractory and require alternative treatments for symptom relief.^3,4,5

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 treatment. Other procedural treatments including focused ultrasound or cobalt-based radiosurgery require an invasive head frame and multiple hour-long treatments.^1,2,3,5

Now, this condition can be addressed using linear accelerator-based stereotactic radiosurgery (SRS) targeting the area involved in tremors. Varian’s TrueBeam and Edge systems are the first linear accelerators with FDA clearance for this indication.

“TrueBeam and Edge radiotherapy systems are designed to precisely target tumors and other conditions with radiation,” says Raymond Schulz, MSc, Director, Global Radiosurgery Programs, Office of Medical Affairs at Varian, “Thanks to the recent FDA clearance, we can expand access to this advanced technology to patients with medically refractory essential tremors, providing them with a new, less-invasive option and the potential for symptom relief. Our hope is that this option will improve the lives of the many patients who otherwise would have to live with untreatable essential tremors.”

A version of this article first appeared in Centerline, Varian’s online magazine for the clinical oncology community. Visit www.varian.com/centerline.

TRUEBEAM and EDGE are trademarks of Varian Medical Systems, Inc., pending or registered U.S. Pat. & Tm. Off.

“Essential Tremor.” Mayo Clinic, March 29, 2023.
2.   Louis, Elan D. “Treatment of Medically Refractory Essential Tremor.” New England Journal of Medicine 375, no. 8 (2016): 792–93.
3.   “Focused Ultrasound Therapy for the Treatment of Medication Refractory Essential Tremor.” Pennmedicine.org, January 31, 2023.
4.   “Essential Tremor: Medlineplus Genetics.” MedlinePlus. Accessed July 12, 2023.
5.   “Essential Tremor Treatment: Johns Hopkins Neurology and Neurosurgery.” Johns Hopkins Medicine, March 21, 2023.