FREQUENTLY ASKED QUESTIONS

Hospital FAQs

How many patients can I expect to treat in a year?


A facility's volume will depend on a range of factors: number of physicians in the practice, practice volume, demographics of the patient population, and other treatment options available in the practice.




How many procedures will I need to perform in one year for a system acquisition to make sense?


Based on current average charges per case, it is estimated that under the terms of a typical lease it will take one patient per month to cover the carrying costs of the lease.




How much does a system cost?


For more information on system cost please fill out the form at the bottom of this page to be contacted by a sales representative.




What are the technologist/technical support requirements?


Internal technical support is needed to setup, tear down, and disinfect the system after the procedure. As part of Sonablate Corp’s training program, a clinical applications specialist will train internal technical staff on the setup, takedown, cleaning, disinfection, and sterilization protocols for each component of the Sonablate system. Sonablate 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 for all cases through Sonalink. Please note that the Sonablate clinical applications specialist will be present in a training capacity only; physicians and internal staff will be responsible for the Sonablate system setup and takedown, the performance of the Sonablate procedure, and patient care.




What is Sonalink?


Sonalink is a remote viewing telecommunication application that comes standard on every Sonablate system and is accessible by any facility that is in compliance with the terms of their purchase agreement. Sonalink “links” the Sonablate device being used to deliver a case with remote support personnel. Two-way visual and auditory communication is provided between the physician and remote personnel, along with a screen mirroring app. Sonalink allows the complete procedure, ranging from device setup to active computer-controlled HIFU delivery, to be remotely monitored by experienced support personnel. These specialists have the ability to interact with the physician and OR staff in real-time to answer questions and provide ongoing training and guidance in the use of the device.




What mobility options can you provide with your products?


Sonablate Corp. supports a “transportability model.” This includes a limited number of locations that share a single device, with physicians and staff being fully trained at each of the locations where the device is used.
Currently, Sonablate Corp. limits the number of locations to a total of three. To learn more about mobilization for your HIFU practice please see the "contact us" page of our website.




Do your HIFU products have regulatory clearance from the FDA?


Yes... Sonablate is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Sonatherm is indicated for the laparoscopic or intraoperative ablation of soft tissue from the ultrasound focal zone back to the surface of the targeted ablation area in General Surgery. The Sonatherm is not to be used for non-invasive ablation, i.e. leaving intervening tissue spared, and it is not indicated for the ablation of Prostate tissue.




Where is a Sonablate procedure performed?


SonaSurgery can be performed wherever the required resources (anesthesia, power, internet, nursing, recovery room, etc.) are available.




What patients can be treated; can Sonablate deliver a focal procedure?


Sonablate is FDA 510(k) cleared for use in the ablation of prostate tissue. The device can be used to ablate any portion or amount of the gland appropriate for ablation as long as surrounding structures are protected. The clinical use of Sonablate is determined by the physician user.




Does the system integrate with MRI?


Sonablate does not work directly in an MRI environment. It does provide support for MRI/US fusion systems that have been developed to support MRI guided biopsies. Sonablate Corp. has adapted the fusion algorithms developed by select third parties and implemented them in the Sonablate planning system, so that regions of interest identified on an MRI can be overlaid in correct locations on an intraoperative ultrasound image generated at the time of delivering a focused ultrasound ablation.




What options do patients have for reimbursement?


The Centers for Medicare and Medicaid Services (CMS) accepted the application for a HIFU C-code which went into effect on July 1st, 2017. Effective January 1, 2021, the C-code was replaced by a category 1 Current Procedural Terminology (CPT) code. The CPT code 55880, under the ambulatory payment classification (APC) 5375, is specific to the ablation of malignant prostate tissue using high intensity focused ultrasound (HIFU) via a transrectal approach. 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 CPT 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.





Patient FAQs

What is HIFU?


HIFU or High Intensity Focused Ultrasound is energy used to ablate tissue within the body. HIFU directs sound waves to a specific location within the prostate called the focal point. At the focal point the tissue temperature rapidly rises to almost 195 degrees Fahrenheit (90 degrees Celsius) where the targeted tissue is destroyed and while the tissue located outside the focal lesion remains unharmed.




Am I a Sonablate Candidate?


Please consult your personal urologist for qualifications and/or restrictions about becoming a Sonablate patient.




Why choose HIFU?


Sonablate HIFU is a minimally invasive prostate tissue ablation option that allows the physician to deliver precise and focused ablation. HIFU uses ultrasound energy, not radiation, to destroy targeted tissue so the procedure can be repeated, if necessary. It is up to you and your physician to determine if Sonablate HIFU is an option for you.




What features are unique to the Sonablate product that are focused on patient safety ?


  • Rectal wall monitoring helps determine the temperature of and proximity to the rectal wall. This helps the physician protect the rectal wall tissue during therapy.
  • The active cooling system circulates chilled water through the probe during the procedure while monitoring temperature, which helps the physician protect the rectal wall tissue from heat generated during thermal ablation.
  • Real-time imaging allows the physician to view and compare the original image to the real-time image being treated, for visual ablation confirmation.
  • MRI/US fusion integration software allows the physician to merge MRI images into the Sonablate planning software, fusing them with the real-time ultrasound images. The physician can then determine a more precise ablation plan based on the fusion of these two key datasets.
TCM or Tissue Change Monitoring is a color display that (during tissue ablation) gives the physician enhanced feedback about the change in tissue at each point of HIFU delivery.




Is the Sonablate procedure performed in an outpatient setting?


Yes, this is typically an outpatient procedure.




How long does the Sonablate procedure take?


Usually, the procedure last approximately 2-4 hours. This depends on the amount of prostate tissue being ablated during the procedure.




Should I expect a urinary catheter after my procedure?


Yes, you may have a urinary catheter after your procedure. It will be up to your doctor to determine what type of catheter and how long you may need to have the catheter.




How long does it take to recover from a Sonablate procedure?


After a Sonablate procedure, patients can expect to be in recovery for about 2-4 hours. While it is recommended for patients to take things easy, most patients feel well enough to enjoy mild activities the evening after their procedure, such as going out to dinner or taking a walk. Please consult your personal physician about the procedure process best suited for you. Procedure and recovery requirements may vary among different health care providers.




Where can I find a Sonablate physician?


We have a list of Sonablate physicians located on our website, CLICK HERE to find a physician near you.




What is the cost of a Sonablate Procedure?


The cost of a Sonablate procedure varies among different healthcare providers. Please consult your HIFU physician for more information about costs and payments.




Can I expect insurance reimbursement for a Sonablate procedure?


The Centers for Medicare and Medicaid Services (CMS) accepted the application for a HIFU C-code which went into effect on July 1st, 2017. Effective January 1, 2021, the C-code was replaced by a category 1 Current Procedural Terminology (CPT) code. The CPT code 55880, under the ambulatory payment classification (APC) 5375, is specific to the ablation of malignant prostate tissue using high intensity focused ultrasound (HIFU) via a transrectal approach. 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 CPT 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.





Physician FAQs

What is the learning curve for HIFU?


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 Account Managers and Case Support Specialists.) Physicians are encouraged to utilize Sonablate Corp's exclusive telemonitoring feature, Sonalink, to connect with a clinical applications specialist for the subsequent cases.




What is your training program?


The Sonablate Corp. training program consists of didactic, online simulator training, a live case observation, and up to 5 in-person procedures with a Case Support Specialist and/or Clinical Account Manager (up to 2 visits).




What are the technologist requirements ?


Hospital or ASC technical support is needed to set up, break-down, and disinfect the system post-procedure. Our expert Case Support Specialists will train internal technical staff on the aforementioned including sterilization protocols for each component of the Sonablate system. Sonablate Corp. 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 Case Support Specialists 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.




What are contraindications for a Sonablate procedure?


  • 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.




How long does a procedure take to deliver?


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.




What size prostate can be ablated?


Sonablate can ablate a prostate with an AP height of up to 3.7cm.




What are the anesthesia requirements?


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.




What is the typical patient recovery time?


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




What type of catheter is used and how long is it left in place?


It will be up to the doctor to determine what type of catheter is used and how long the catheter should remain in place after a Sonablate procedure.




What is the cost of the Sonablate system?


For more information on system pricing, please click "CONTACT US" at the bottom of the page.




Is there insurance reimbursement for the Sonablate procedure?


The Centers for Medicare and Medicaid Services (CMS) accepted the application for a HIFU C-code which went into effect on July 1st, 2017. Effective January 1, 2021, the C-code was replaced by a category 1 Current Procedural Terminology (CPT) code. The CPT code 55880, under the ambulatory payment classification (APC) 5375, is specific to the ablation of malignant prostate tissue using high intensity focused ultrasound (HIFU) via a transrectal approach. 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 CPT 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.





Regulatory Statement

Sonablate® has 510(K) clearance in the U.S. and is indicated for the transrectal high intensity focused ultrasound (HIFU) ablation of prostatic tissue. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

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