Histotripsy: HistoSonics Edison™ Robotic System

Histotripsy is a non-invasive medical procedure that uses high-intensity sound waves to destroy liver tumors. Unlike other treatment methods, histotripsy does not require your doctor to make cuts or incisions, use needles, or rely on ionizing radiation. The procedure can be performed under general anesthesia and involves the use of ultrasound imaging to locate the targeted tissue and monitor the treatment in real-time.

How is Histotripsy Performed?

Histotripsy involves placing a treatment head, which emits the sound waves, inside a soft, flexible membrane containing specially treated water. This membrane is then positioned on your abdomen and directed at the liver tumor.

The sound waves create a bubble cloud from the rapid expansion and collapse of naturally-occurring gas bubbles within your tissue. This bubble cloud destroys the targeted tissue.

What are the Benefits of Histotripsy?

Non-invasive:
The procedure does not require any incisions, needles, or other insertions through the skin which can help reduce the risk of infection, bleeding, long recovery times and other complications.

Single Treatment:
Most tumors can be effectively destroyed in a single treatment session. Depending on your clinical condition and treatment plan, multiple treatment sessions may be necessary.

Targeted:
Histotripsy can be used to precisely target and destroy unwanted tissue, such as tumors, while minimizing damage to surrounding tissue.

All medical procedures involve risk. Patients should consult their physician for more information and to understand the risks and benefits of histotripsy of the liver. Histotripsy results in the destruction of liver tissue, including liver tumors, which may impact overall liver function. During the clinical trial, the most common side effects experienced were procedural pain, abdominal pain and fever. Each patient’s experience will vary.

The histotripsy procedure may be performed under general anesthesia and can be completed in as little as one treatment, depending on the severity of your condition. Histotripsy procedures involve many patient-specific variables and conditions, including the size and location of the targeted tissue, that impact the length of procedure, anesthetic and other clinical aspects.

Step 1: Consultation
If histotripsy is right for you, you will meet your doctor who will answer your questions and discuss your eligibility for this procedure. If approved for histotripsy, you will schedule a date and time for the procedure.

Step 2: Prep
Your doctor may require you to follow some dietary restrictions before the planned histotripsy. Be sure to follow all instructions before your planned date.

Step 3: Day of Procedure
You will be guided into a room with a histotripsy system. Your doctor may perform an ultrasound for additional confirmation of your tumor location. General anesthesia will be administered and your doctor will place a histotripsy treatment head over the targeted tumor.

Step 4: Histotripsy Begins
During the procedure, the treatment head delivers sound waves to the targeted area while your doctor uses ultrasound imaging to monitor the treatment.

Step 5: Duration of Treatment
The procedure time will vary depending on specific variables and the number of histotripsy treatments delivered in one session.

Step 6: Recovery
After the treatment, you may experience some pain, depending on the treatment area. Many patients can return home the same day or day after the procedure and usually resume their normal activities quickly.

If you are interested in learning more about whether histotripsy is right for you, contact your liver specialist or call 541.667.3400, extension 1543 to schedule an appointment. Appointments can also be made at [email protected].

Will I need to stay in the hospital after my procedure?
Whether or not you need to stay overnight in the hospital after the procedure depends on several factors, including whether you are experiencing any pain and how you feel overall.

The doctor will decide based on your individual situation.

Can I have another type of procedure in the future after histotripsy?
Yes. Currently, there are no contraindications with other treatments. Histotripsy has been used before, after or in combination with other procedures. The decision to incorporate histotripsy and the potential impact on future clinical decisions should be discussed with your physician.

What is it like to have a histotripsy procedure?
If you are eligible to be treated with histotripsy, you will be scheduled for an outpatient ultrasound screening evaluation of your liver before the actual histotripsy treatment.

This evaluation is done to make sure that your liver tumor(s) can be accurately targeted and safely treated with histotripsy. If this evaluation confirms that your tumor(s) can be treated with histotripsy, you will be scheduled for treatment.

• On the day of your histotripsy treatment, you will be asked to avoid food or drinks for 8 hours prior to treatment.
• On arrival, you will meet an anesthesiologist and nurse.

The active histotripsy time will vary depending on the size and location of your tumor. In our #HOPE4LIVER Trial the mean histotripsy treatment time per tumor was 34 +/- 24 minutes. Histotripsy treatment times have been reduced since the #HOPE4LIVER Trial. The full procedure time usually ranges from 1-3 hours but some could be longer depending on a variety of factors, including the number of tumors being treated.

Most procedures will be performed on an outpatient basis, allowing you to return home the same or following day. One month after treatment, you will have a contrast enhanced CT or MRI scan to evaluate the treated tumor(s).

Will I need to be put to sleep for the procedure?
Currently, we are using general anesthesia to perform the procedure. Histotripsy is a highly precise treatment; general anesthesia is primarily used to control patient movement during the procedure rather than to manage the pain.

How long does a histotripsy procedure take?
The active histotripsy time will vary depending on the size and location of your tumor. In our #HOPE4LIVER Trial, the mean histotripsy procedure time was 34 + / – 24 minutes. Histotripsy treatment times have been reduced since the #HOPE4LIVER Trial. The full procedure time usually ranges from 1-3 hours but some could be longer depending on a variety of factors, including the number of tumors being treated.

Does insurance/Medicare cover histotripsy of the liver?
Medicare should cover the procedure if it is reasonable and necessary. However, it will be necessary to have your selected histotripsy provider verify coverage with private insurance. As a new treatment option, treatment coverage and payment are still being established with the different insurance companies.

How do I know if I’m a candidate?
Any patient with liver tumors might be a candidate for histotripsy. If you are interested in learning more about whether histotripsy is right for you, contact your liver specialist or call 541.667.3400, extension 1543 to schedule an appointment. Appointments can also be made at [email protected].

Will I feel pain during or after the procedure?
The histotripsy procedure is typically performed under general anesthesia so you should not experience pain during the procedure.
You may feel some pain after treatment depending on the area treated, but there are no incision wounds, and many times you can return to normal activities quickly.

In our #HOPE4LIVER Trial, the most common adverse device effects were abdominal pain, procedural pain and fever.

Is the histotripsy procedure safe?
Histotripsy has been studied in laboratories for over 20 years with clinical trials beginning in 2018. In a clinical trial conducted in 2019, it was used to successfully in humans to destroy liver tumors¹.

The #HOPE4LIVER trials demonstrated successful use of histotripsy in patients with primary and metastatic tumors in the liver in the US and EU^2,3.

1 THERESA Trial, 2019. https://clinicaltrials.gov/ct2/show/NCT03741088
2 #HOPE4LIVER US https://clinicaltrials.gov/ct2/show/NCT04572633
3 #HOPE4LIVER EU https://clinicaltrials.gov/ct2/show/NCT04573881