A committed Physician can learn the procedure after completing the online training, a live case observation, simulator training, and their initial 5 cases (performed alongside our Clinical Urology Specialist and Technical Proctors.) Physicians are encouraged to utilize SonaCare Medical’s exclusive telemonitoring feature, Sonalink, to connect with a clinical applications specialist for the subsequent cases.

The SonaCare training program consists of didactic, online simulator training, a live case observation, and up to 5 in-person procedures with Technical Proctor and/or Clinical Urology Specialists (up to 2 visits).

Hospital or ASC technical support is needed to set up, break-down, and disinfect the system post-procedure. Our expert Technical  Proctors will train internal technical staff on the aforementioned including sterilization protocols for each component of the Sonablate system. SonaCare provides on-site technical support to the physician and staff as part of a system purchase for a variable number of cases/visits and makes remote technical support available through Sonalink. Please note that the SonaCare Technical Proctors will be present in a training capacity only; physicians and internal staff will be responsible for the Sonablate system setup and break-down, the performance of the Sonablate procedure, and patient care.

• Presence of significant (>10mm) fluid-filled cavities (for example, cysts), large reflective surfaces (for example, significant calcifications >10mm, urethral stent) observed in the planned ablation zone. Varying attenuation among these tissues may cause an unpredictable size of lesion.
  
  
• Metal implants or stents in the urethra, within the area to be ablated
  
  
• Presence of brachytherapy seeds adjacent to the posterior prostate capsule, the Denonvilliers’ fascia, or the rectal wall
  
  
• Preexisting inflammatory disease of the colon or rectum; including proctitis, ulcerative colitis
  
  
• Prior significant rectal surgery
  
  
• Inability to insert or tolerate a transrectal ultrasound probe
  
  
• Active urinary tract infection
  
  
• Urethral stricture
  
  
• Latex allergy.  Note:  Ablation with Sonablate requires that the transrectal probe be covered with a sheath prior to insertion, and the sheath provided for use is made from natural rubber latex. For those patients who are allergic to latex, a non-latex ultrasound probe sheath is available as an option; please contact your distributor or SonaCare Medical.

Procedure times range from est. >2hrs depending on the volume of tissue being ablated. A focal ablation takes less time vs. whole gland ablation. The initial cases tend to be longer due to the learning curve. 

Use of Nitrous Oxide should be AVOIDED

General anesthesia is typically used, but spinal with conscious sedation is an option.  The key is that the patient cannot move during the procedure. 

• 2-3 hours in recovery at the surgery center/hospital
  
  
• Patient able to return to normal activities within 1-2 days
  
  
• Catheter in place for 5-21 days     

The Centers for Medicare and Medicaid Services (CMS) accepted the application for a HIFU C-code which went into effect on July 1st, 2017. 

The HCPCS code C9747, under the ambulatory payment classification (APC) 5376, is specific to the ablation of prostate tissue using transrectally delivered high intensity focused ultrasound (HIFU), and includes image guidance. It will be applicable to procedures performed using Sonablate®, including but not limited to primary whole gland ablation, sub-total ablation, and salvage ablation. This C-code is applicable to procedures performed in hospitals and ASC facilities under the Medicare Hospital Outpatient Prospective Payment System (OPPS) and may also be applied to claims from other providers in the future.