This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Probable Benefit (SSPB) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Sonalleve MR-HIFU
HDE Applicant: Profound Medical Inc.
Address: 2400 Skymark Avenue, Unit #6,
Mississauga, Ontario L4W 5K5, Canada
Approval Date: November 27, 2020
Approval Letter: Approval Order

What is it?

The Sonalleve MR-HIFU uses magnetic resonance imaging (MRI) to help health care professionals deliver focused, high intensity ultrasound (sound) energy to treat osteoid osteomas, a benign painful bone tumor that usually forms in the arms or legs of children and young adults.

How does it work?

The Sonalleve MR-HIFU system uses an ultrasound transducer to deliver a focused, high intensity ultrasound beam to heat and destroy (ablate) target tissue.  During the treatment, the health care professional uses the thermal images created from the MRI to monitor the progress of the tissue temperature rise and ablation.

When is it used?

The Sonalleve MR-HIFU system is intended to be used for the treatment of osteoid osteomas in the arms and legs.

What will it accomplish?

The clinical results support the probable benefit of the Sonalleve MR-HIFU for the treatment of painful osteoid osteomas. In a clinical study, nine patients between the ages of 7 and 24 were treated with Sonalleve MR-HIFU. Within four weeks, eight of the nine patients experienced long-term pain relief and did not need any pain medication.

When should it not be used?

The Sonalleve MR-HIFU should not be used if:

• MRI is not possible.
• The target tissue is located less than one centimeter from a critical nerve, the bladder, the skin, or the intestines.
• The target tissue is located less than one centimeter from the growth plate.
• The target tissue is located in the skull.
• The target tissue is located in weak or damaged bone.
• Scars, implants, or other metallic objects are in the planned path of the ultrasound beam.
• The patient cannot stay in a fixed position during the procedure.

Additional information (including warnings, precautions, and adverse events):

• Summary of Safety and Probable Benefit
• Labeling
• Labeling Part 2
• HDE Database Entry