Value For Patients
- Fast, out-patient procedure with short recovery at home
- Non-invasive therapy: no surgery, no scars, no ionizing radiation
The Sonalleve value
Value For Clinicians
- Innovative, cutting edge technology with robotic control and real-time MRI precision
- Direct Skin Cooling for enhanced treatment efficiency
- Provides new procedures to meet current unmet needs
- No ionizing radiation, procedures can be repeated if needed
Value For The Health Care System
- Attractive out-patient procedures
- Efficient utilization: Easy switching between diagnostic and therapeutic use of the MR scanner
- Reduce patient length of stays and associated costs
Technology
Incision-Free
Sonalleve uses High Intensity Focused Ultrasound (HIFU) to concentrate ultrasound waves from outside the body into a target deep beneath the intact skin, thermally ablating the lesion without an incision and without affecting nearby tissue.
Real-Time MRI Temperature Monitoring and Control
Sonalleve uses the MRI scanner to measure temperature changes within the body in real-time. During treatment, temperature images are used to automatically adjust HIFU parameters for tissue changes and blood flow.
Make The Most Of Each Treatment
Sonalleve uses the combination of HIFU and MRI temperature control to enable efficient volumetric thermal ablation. By rapidly scanning the HIFU beam, ellipsoidal regions up to 16mm wide and 40mm long can be thermally ablated within seconds, covering large target volumes with just a few heating events. MRI temperature control optimizes ablation time and uniformity.
Work Quickly And Efficiently to Keep Treatment Times Short
Reduce cooling time between sonications with Direct Skin Cooling (DISC) and Dual Mode Thermometry (DMT). DISC keeps your patient’s skin at a constant temperature by circulating cooled water within the ultrasound window, directly against the skin surface. DMT measures temperature in subcutaneous fat to calculate patient-specific suggested cooling times, to support treatment efficiency and reduce the likelihood of side effects.
Patient Comfort
The curved tabletop is designed to relax the patient’s shoulders for extra comfort. The large ultrasound window can reach a large treatment area for easy patient positioning.
Easy Set-Up
The dedicated Sonalleve table is compatible with your Philips MRI system, and easily slides over the lowered MR table so you do not have to move patients or remove the MR table. Switch between diagnostic MR and HIFU therapy in a few minutes.
Disclaimer: SONALLEVE®MR-HIFU is approved for commercial sale in the European Union (EU) for ablation of uterine fibroids or adenomyotic tissue, bone pain palliation associated with bone metastasis, treatment of osteoid osteoma, and management of benign desmoid tumors.
In the United States, SONALLEVE®MR-HIFU is approved by the U.S. Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE) for the treatment of osteoid osteoma only.
The availability of SONALLEVE® may vary by country and is subject to local regulatory approvals. Not all indications described may be approved in every market.
For detailed information regarding the regulatory status of SONALLEVE® in your region, please contact [email protected].
106731C
CAUTION: Products shown may not be approved for sale in all jurisdictions. Rx only device.
Contact us at [email protected] for more information regarding the regulatory status of the device.