Major Developments Expected in 2012


The positive energy surrounding the field of focused ultrasound has reached unprecedented levels. During the last 60 days, recognition in TIME magazine and viewership of the TEDMED video have caused “an explosion in public awareness of the promise and potential of this revolutionary technology,” according to FUS Foundation Chairman Neal F. Kassell, MD. As a result, he says, demand for rapid development of focused ultrasound treatments is greater than ever before.

Kassell expects momentum to continue building in the year ahead. “The pace is definitely accelerating. We anticipate that 2012 will be a year of significant developments, especially in the clinical arena,” he notes.

Kassell’s list of anticipated major developments includes:

  • FDA approval of InSightec’s second commercial FUS indication – InSightec’s PMA submission regarding the use of its ExAblate System to palliate pain associated with bone metastases is now in full review at the FDA. Given a green light, bone mets will become the second FDA-approved indication for the ExAblate. (The system received approval to treat uterine fibroids in 2004.)
  • Essential tremor remains in the spotlight –During the American Association of Neurological Surgeons (AANS) meeting in April, University of Virginia neurosurgeon W. Jeffrey Elias, MD will present the final results of last year’s FUS Foundation-funded, first-in-the-world clinical trial. Conducted under InSightec’s FDA-approved IDE, the study used the ExAblate Brain System to treat 15 patients with essential tremor. Kassell says that plans for continued access at UVA and a multi-center pivotal clinical trial are now on the drawing board.
  • FUS clinical trials hit record level –By all estimations, 2012 will be a record-setting year for the launch of focused ultrasound pilot clinical trials. According to Kassell, the list includes new clinical investigations involving patients with brain tumors, Parkinson’s disease, epilepsy, breast cancer, obsessive compulsive disorder and prostate tumors.

Additionally, Philips Healthcare is set to launch its pivotal U.S. trial for the treatment of uterine fibroids with its Sonalleve MR-HIFU System. The Sonalleve received CE marking in December 2009 and is now treating patients at more than 40 sites outside the U.S.

  • FUS Foundation designates new Center of Excellence – Kassell says an announcement is imminent regarding the designation of the foundation’s second Focused Ultrasound Center of Excellence. Like the foundation’s inaugural Center of Excellence at the University of Virginia, the new luminary site will be a multi-disciplinary, multi-departmental effort. It is being created through a partnership involving the site, an industry partner and the foundation.
  • 3rd International Symposium on Focused Ultrasound energizes the worldwide clinical research community – Scheduled for October 14-17 in Bethesda, Maryland, the foundation’s third international symposium promises to surpass its two predecessors in terms of content and attendance. The 2012 meeting will be the first to span three full days and to expand its scope beyond MR-guided focused ultrasound therapies.

Written by Ellen C., McKenna