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1. Introduction to Sonalleve MR-HIFU > 1.3. Intended use
CAUTION
In the United States of America:
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
NOTICE
This Sonalleve MR-HIFU System is NOT intended for diagnostic imaging. Several image quality
and other performance compromises have been made, which make this system inadequate for
general diagnostics.
1.3.1. Sonalleve Desmoid Application
The Sonalleve MR-HIFU Desmoid Application is intended for management of benign desmoid
tumors. The desmoid tumors to be treated must be visible on MR imaging and accessible to HIFU
therapy.
Adverse Effects
Although the MR-HIFU treatment of desmoids is generally safe and often causes the patient little or
no pain, potential adverse effects have been reported in literature. Most of these effects are
transitory and can be avoided with careful treatment planning.
This list of adverse effects and the estimates on their frequency of occurrence are based on reports
in literature. References to the relevant literature will be supplied on request by your local Profound
Medical application support representative.
Tab. 1: Potential adverse effects of MR-HIFU treatment, Desmoid application.
Frequency
Potential transitory
effects
Less frequent
transitory effects
Instructions for Use
109745C2 / 02-2022
Occurrence in
Source
patients
~ 30% of
HIFU
patients
< 10% of
HIFU
patients
Catheter
Adverse effects
Nausea or vomiting
Pain
First degree skin burns
Fever
Tenderness near the treatment area
Second degree skin burns
Swelling
Thermal injury to internal tissue
Urinary difficulty
8 (192)
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