FDA clears new version of InSightec's ExAblate 2000

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The FDA has approved software that speeds up the treatment time of InSightec’s ExAblate 2000 Magnetic Resonance guided Focused Ultrasound (MRgFUS) system, while ensuring the system's high level of safety and efficacy. Also, the FDA also approved the ExAblate 2000 to be used with a 3.0 Tesla MRI scanner, in addition to a 1.5 scanner. 

"The newly-approved system allows the incisionless ExAblate procedure to be performed more efficiently than the conventional method and permits more sonications during the same treatment window," said George A. Holland, MD, director of MRI at the Lahey Clinic in Burlington, Mass.

In a presentation Holland gave at the International Society for Magnetic Resonance in Medicine in May last year he stated that "Using this technique, women with fibroids can be treated faster and women with larger fibroids may now be eligible for the outpatient procedure. The more of the fibroid that a physician can treat, the greater the symptom relief."

The new system version utilizes an ‘interleaved’ mode of treatment whereby the system targets different parts of the fibroid, allowing the recently ablated tissue area to cool while the focus moves onto other areas of the fibroid. This reduces the cooling time required. Another new feature allows physicians to leverage the beam steering in phased array transducer to maximize the energy in the focal point, allowing significantly more volume to be treated for the same amount of energy applied, the company said.

The new system version also includes improved safety features that help the physician identify anatomical details (such as bowels, bones, nerves) to help plan the treatment and minimize damage to non-targeted tissue.

The Lahey Clinic in Burlington, Mass.; the University of California at San Diego (UCSD); Weill Cornell Medical Center in New York; and KNI Imaging in Kalamazoo, Mich., each participated in a 40-patient study to evaluate the new system version.

The ExAblate 2000, which was previously available in Europe and Asia, is the only MRgFUS system approved by the FDA as a non-invasive, outpatient procedure to treat uterine fibroids, the company said.