Sonalleve MR-HIFU

Sonalleve MR-HIFU is a medical system developed by Philips Healthcare for the treatment of uterine fibroids without surgery. The system uses non-invasive high-intensity focused ultrasound (HIFU) guided by magnetic resonance (MR), whence the acronym MR-HIFU. The procedure involves volumetric heating of fibroids with real-time feedback.[1] In June 2017, Philips and Profound Medical announced an agreement to transfer Philips' MR-HIFU business, which includes the Sonalleve system, to Profound Medical.[2]

Sonalleve HIFU

Technology overview

The Sonalleve high frequency focused ultrasound uses a special transducer to focus a beam of ultrasound waves on to the fibroid located within the body. The focused ultrasound waves generate high temperatures within smaller areas. The temperature when maintained for sufficient a period of time results in the ablation of the fibroids. The therapy procedure guided by Magnetic Resonance Imaging (MRI) with real time feedback helps in the focused ablation of the target location.[3] The real-time feedback loop ensures that adequate heating takes place, treating every bit of tissue that has been targeted and volumetric ablation (a Philips proprietary technology) helps treat larger volumes efficiently and quickly.[4]

Device approvals

The Sonalleve is approved for treating uterine fibroids in Europe, most of Asia, the Middle East and South America. Philips has received CE Marking for its Sonalleve MR-HIFU system. Equivalent to Food and Drug Administration (FDA) approval in the U.S., CE Marking is recognized by countries in the European Economic Area, Asia, South America and Africa and signifies that a product complies with the essential requirements of relevant health, safety and environmental protection legislation.[5]

The company has also applied for FDA approval for the system.[6] The process for clinical trials and study are already underway.[7] The device is also approved for the treatment of bone metastasis[5] and is undergoing development for the treatment of prostate cancer and breast cancer.[8]

Treatment procedure

The method is quicker and comfortable compared to the conventional procedures currently done for the treatment of uterine fibroids such as hysterectomy, myomectomy or uterine artery embolization. The procedure is usually done on an outpatient basis with the patient leaving the hospital on the same day.[9] The patient may be kept for observation for another 24 hours.

The procedure is performed in three stages:[9]

Planning stage

Patients undergo evaluation using three-dimensional MR imaging to determine their eligibility for treatment. If they meet the criteria, their condition is assessed and treatment planning is scheduled. During the appointment, patients are positioned on the MRI table in a prone position, ensuring proper acoustic coupling. The treatment areas are marked based on MR images. Intravenous fluids or conscious sedatives may be administered, and a non-lethal dose of ultrasound waves might be delivered as a test to ensure accuracy.

Non-invasive treatment stage

High-intensity ultrasound waves are focused onto the fibroids which elevates its temperature and causes the tissue to coagulate. The process is done in multiple sonications with the number and duration depending on the size and extent of fibroids. The process will be closely monitored and controlled by MR imaging and feedback to confirm the accuracy and effectiveness of the treatment. In case of any discomfort, the patient can stop the process through a hand held device button.

Therapy verification stage

At the end of treatment, contrast enhanced MR imaging is used to assess the effectiveness of the procedure. These images are used to determine the Non-Perfused Volume (NPV) of the fibroid, which is the volume of tissue that is non-viable (has no blood flow to it).[10]

Treatment setup

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,[11] and comprises the following interconnected subsystems:

  • Achieva MR system to monitor the procedure and provide real-time images
  • MR-HIFU patient tabletop with integrated MR compatible high power phased array transducer with mechanical and electronic positioning
  • MR-HIFU therapy console to plan treatment, calculate real-time temperature maps, and control HIFU delivery
  • HIFU electronics for ultrasound power (energy) delivery and beam positioning [1]

Treatment benefits

For the doctors it offers easy planning, treatment with real-time feedback and a solution to those who would otherwise decline surgical treatment. For the patients it offers an alternative non-invasive treatment mechanism involving no anesthesia and a short recovery time. [9]

Locations

The system was initially installed in about 16 locations in the U.S., Europe and Asia for research purposes.[12] Philips has installed around 50 of its Sonalleve MR-HIFU systems worldwide with most of the systems in Asia and Europe.[8]

India has seven installed systems in five cities.[13] Apollo Hospitals[14] has the setup installed at three of its facilities Chennai, Bangalore and New Delhi.[15] The treatment is also available in Clumax Diagnostics, Bangalore,[16] Bharat Scans, Chennai,[17] SRL Jankharia Imaging, Mumbai[18] and Sunrise Hospital, Kochi.

S No Name of center Location City State
1Indraprastha Apollo HospitalSarita ViharNew DelhiNational Capital Region
2Apollo Specialty Hospital and Cancer CentreTeynampetChennaiTamil Nadu
3Apollo HospitalBannerghatta RoadBangaloreKarnataka
4SRL Jankharia's Imaging CentreGirgaonMumbaiMaharashtra
5Bharat Scans Private LimitedRoyapettahChennaiTamil Nadu
6Medall's Clumax Diagnostics CentreSadhashivanagarBangaloreKarnataka
7Sunrise HospitalKakkanadKochiKerala

See also

References
  1. Philips FieldStrength Issue 36 - December 2008
  2. "Philips expands collaboration with Profound Medical Corp. in MR-guided ultrasound ablation therapies". Philips News Center.
  3. Philips FieldStrength Issue 40 - May 2010
  4. "Welcome Sonalleve MRI guided High Intensity Focused Ultrasound". www.apollohealthcity.com. Archived from the original on 2 July 2012. Retrieved 22 May 2022.
  5. "Philips Sonalleve receives CE Mark for MR-guided focused ultrasound ablation of metastatic bone cancer | Blog". Archived from the original on 2012-05-10. Retrieved 2012-05-07.
  6. "Philips prepares for launch of U.S. Pivotal trial for uterine fibroids | Newsletter Articles". Archived from the original on 2012-03-02. Retrieved 2012-05-07.
  7. "Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids - Full Text View - ClinicalTrials.gov". Retrieved 23 September 2016.
  8. "Asian markets are leading the way – an update on worldwide focused ultrasound adoption | Newsletter Articles". Archived from the original on 2012-04-27. Retrieved 2012-05-07.
  9. "Philips Health Care - Cuidados com a Saúde". Retrieved 23 September 2016.
  10. Stewart EA, Gostout B, Rabinovici J, Kim HS, Regan L, Tempany CM (2007). "Sustained relief of leiomyoma symptoms by using focused ultrasound surgery". Obstet Gynecol. 110 (2 pt 1): 279–287. doi:10.1097/01.AOG.0000275283.39475.f6. PMID 17666601. S2CID 6650678.
  11. "Philips Healthcare - Magnetic Resonance". Retrieved 23 September 2016.
  12. "Investigational Sonalleve MR-HIFU system showcased at ISMRM".
  13. "Life Uninterrupted « Life is beautiful, fun and grace". Archived from the original on 18 September 2012. Retrieved 23 September 2016.
  14. "Apollo Hospitals | Bypass Surgery India | Bariatric, Gastric Surgery in India | Bariatric Surgery Hospital India". Archived from the original on 2013-01-18. Retrieved 2013-01-22.
  15. hyderabadhealthcare (27 August 2011). "Apollo Hospitals Announces the Launch of Breakthrough Technology HIFU". Archived from the original on 2021-12-15. Retrieved 23 September 2016 – via YouTube.
  16. "BioSpectrum - Pharma - Clumax Diagnostics announces the launch of HIFU for treatment of uterine fibroids". Archived from the original on 2011-10-07. Retrieved 2012-05-07.
  17. Subramanian Ramanathan (12 January 2012). "Bharat Scans Xmas & New Yr Celebration 2012 Presentation By Mr. Krishna Kumar (Philips)". Archived from the original on 2021-12-15. Retrieved 23 September 2016 – via YouTube.
  18. http://modernmedicare.co.in/3378/srl-diagnostics-%E2%80%93-jankharia-imaging-announces-the-launch-of-hifu-technology-for-treatment-of-uterine-fibroids.html%5B%5D
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