With advances in medical technology, many traditional treatments are being replaced by safer and more effective options. The Sonalleve MR-HIFU (Magnetic Resonance Image-guided High Intensity Focused Ultrasound) system represents a revolution in non-invasive treatment that can effectively treat uterine fibroids while reducing the need for surgery. The technology, developed by Philips Healthcare, combines high-intensity focused ultrasound with magnetic resonance imaging to enable non-invasive treatment.
Sonalleve high-frequency focused ultrasound uses a special transducer to focus the ultrasound beam onto the fibroids located in the body. The focused ultrasound waves create high temperatures in a small area, and these temperatures over a sufficient period of time will result in ablation of the fibroids.
This treatment uses magnetic resonance imaging (MRI) for real-time feedback to ensure focal ablation at the target location, thereby effectively treating the lesion. The real-time feedback loop functionality allows the ultrasound heating process to be precisely controlled and enables volumetric ablation techniques to treat larger fibroids more quickly and effectively.
The Sonalleve MR-HIFU System is approved in Europe, most Asian countries, the Middle East and South America, and has received the CE mark, which is equivalent to Food and Drug Administration (FDA) approval in the United States. The CE mark is recognized by countries within the European Economic Area, indicating that the product complies with the basic requirements of relevant health, safety and environmental regulations.
In addition, Philips has also applied for FDA approval and clinical trials have already started. The device is also approved for the treatment of bone metastases and is currently being developed for use in the treatment of prostate and breast cancers.
This non-invasive treatment is faster and more comfortable than traditional procedures for treating uterine fibroids, such as hysterectomy, myomectomy or uterine artery embolization. This procedure is usually done on an outpatient basis and the patient can leave the hospital the same day but may need to be observed for an additional 24 hours. The whole process is divided into three stages:
Patients are evaluated with 3D MRI imaging to determine if they are suitable for treatment. If criteria are met, further evaluation and treatment planning will be arranged. During the same-day appointment, the patient is positioned on the MRI table in a prone position to ensure proper coupling of the ultrasound waves, and the treatment area is marked based on the MRI image.
High-intensity ultrasound waves are focused onto the fibroid, raising its temperature and causing the tissue to coagulate. Multiple ultrasound stimulations will be performed continuously, and the number and duration will depend on the size and number of fibroids. The entire process will be closely monitored and controlled through MRI images and feedback to ensure the accuracy and effectiveness of the treatment.
After treatment, contrast-enhanced MRI images are used to evaluate the effectiveness of the treatment. These images are used to determine the nonperfused volume (NPV), the volume of tissue without blood flow.
The Sonalleve MR-HIFU system uses the Philips Achieva 1.5T, 3.0T MR, 3.0T TX or Philips Ingenia 1.5T, 3.0T platform. The system includes the following interactively connected subsystems:
For physicians, this technology offers the possibility of easy planning, with real-time feedback on the course of treatment, and provides a solution for patients who may not be willing to undergo surgery. For patients, it offers a non-invasive option that requires no anesthesia and has a short recovery time.
The Sonalleve system was initially installed at 16 sites in the United States, Europe and Asia for research purposes. Philips currently has approximately 50 Sonalleve MR-HIFU systems installed worldwide, primarily in Asia and Europe. India has seven systems installed in five cities, including three facilities at Apollo Hospitals in Chennai, Bengaluru and New Delhi. In addition, Clumax Diagnostics, Bharat Scans, SRL Jankharia Imaging and Sunrise Hospital also provide this treatment.
With the promotion of the Sonalleve MR-HIFU system, more and more patients will have the opportunity to choose this non-invasive treatment method. So, in the future, can we completely say goodbye to traditional surgical treatment?