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Sonablate HIFU Tissue Change Monitoring

HIFU, which stands for high intensity focused ultrasound is a recently approved new technology for prostate tissue ablation. Many urologists have worked with HIFU for several years to offer their patients a minimally invasive treatment option for prostate cancer, either as a part of a clinical trial or at international treatment centers outside the United States.

There are currently two different medical devices that use HIFU energy to heat and destroy tissue in the prostate. The most technologically advanced HIFU device for prostate cancer is called the Sonablate. The Sonablate is a software directed device that includes a computer console, a transrectal probe and a chilling unit. The Sonablate software that physicians use to plan and execute Sonablate HIFU treatment has state-of-the-art features that make it the safest and most precise HIFU device for prostate disease available.

Using the Sonablate state-of-the-art software physicians obtain real-time images of the prostate that are used to map out and target exactly where HIFU should be delivered. Once treatment plan is mapped, HIFU energy is delivered to those areas.

One of the unique key features that the Sonablate has is called Tissue Change Monitoring, or more simply, TCM.

What is TCM?

The most simple way to explain it is that TCM allows the treating HIFU doctor to monitor changes that happen to the tissue in the prostate after the HIFU energy has been delivered. This monitoring of tissue is important because the doctor will immediately know if enough energy has been delivered to effectively destroy the tissue.

While HIFU is being delivered to heat and destroy tissue in the prostate, physicians have the ability to monitor how the tissue is changing and reacting. The Sonablate gives unique feedback on changes to the tissue so the doctor can monitor exactly what is happening and make adjustments as needed for the best outcomes.

Read the full story here …

High-intensity focused ultrasound or HIFU has many proven advantages over traditional treatment modalities for prostate disease. Visit our website to learn More: www.californiahifu.com #prostatecancer #HIFU #prostate #menshealth

By | December 20th, 2016|HIFU, News, Prostate Cancer|0 Comments

HIFU Prostate Services Expands Management Team with Chief Operating Officer

John McLean brings significant amount of experience in HIFU, operations, marketing and medical imaging.

CHARLOTTE, N.C. March 9, 2016. HIFU Prostate Services, LLC, a leading provider of minimally invasive prostate cancer treatments using high intensity focused ultrasound (“HIFU”), is pleased to announce the addition of John McLean as chief operating officer. McLean brings 17 years of experience in healthcare marketing and management to HIFU Prostate Services and will be responsible for managing treatment teams, training programs and marketing initiatives.

Prior to joining HIFU Prostate Services, McLean spent eight years at SonaCare Medical where he was involved in approximately 600 HIFU cases. While at SonaCare Medical, McLean served as product manager, business manager and service engineer; he brings experience in all areas of running a successful HIFU business.

“After working with John McLean at SonaCare Medical for eight years, it was clear that HIFU Prostate Services could benefit significantly from his experience as we continue to partner with leading urologists and place HIFU systems in the U.S. market.  He will be instrumental in our continued growth and expansion,” said John W. Linn, chief executive officer of HIFU Prostate Services.

“After leaving SonaCare Medical in January, I knew I wanted to continue to work with HIFU technology and help make it more accessible for patients looking for a minimally invasive treatment option. I interviewed several different HIFU companies that are offering treatment as I searched for the one that excelled most in quality of patient care, physician development and advancement of the HIFU technology. It was clear that HIFU Prostate Services has the superior national platform with an experienced HIFU staff and physician network focused on excellent patient care and physician training,” said McLean.

Previously, McLean spent more than nine years in various leadership roles in healthcare ranging from medical imaging companies, healthcare service companies and the U.S. Army; these experiences give him a unique insight into the healthcare industry. McLean has set up and run healthcare support in hospitals, outpatient surgery centers and combat-support hospitals.

HIFU Prostate Services was the first company to offer treatment using Sonablate HIFU technology in November 2015. The company rapidly expanded operations into four centers that will treat nearly 30 patients in March and three additional centers are planned to open this spring.

“We are thrilled to have John on board; his role will focus on the continued growth of the company’s existing treatment centers and support expansion as the company adds six additional treatment locations in the coming months,” said John Harris, chairman of HIFU Prostate Services.

About HIFU Prostate Services, LLC

HIFU Prostate Services (HPS) is the nation’s leading provider of minimally invasive prostate cancer treatment using high intensity focused ultrasound. HPS was founded to provide men access to a less invasive treatment option for prostate cancer that has the ability to eliminate cancer and preserve patient quality of life. Our mission is to deliver the highest quality of care, support, and technology to the patient and to the urology community for the treatment of localized prostate cancer using high intensity focused ultrasound (HIFU) with the Sonablate. HPS was founded in 2015 by a seasoned management team with over 50 years of experience in the healthcare industry and over 30 years focused on HIFU technologies.

HPS has the most experienced HIFU staff in the country with over 60 years of combined HIFU experience. HPS nurses and technicians have been involved in over 3,000 HIFU procedures. The HPS network includes 100 physicians across the U.S., and our physician proctors have experience with over 1,200 HIFU procedures. The company is headquartered in Charlotte, NC and has established partnerships with physicians and urology practices throughout the country.

For more information about HIFU or to make an appointment call (707) 546-5553. Find us online at: www.californiahifu.com.

 

By | March 29th, 2016|Dr. Michael Lazar, HIFU, News|0 Comments

International HIFU Physician Dr. Michael Lazar

It has been very exciting to be able to offer HIFU to men with prostate cancer the past 6 years. The utility of the procedure continues to grow, with the evolution from merely whole gland therapy to the possibility of focal therapy. With MRI imaging improvements, we can not only limit treatment to the cancer focus in appropriate men, we can now better determine which patients are likely to have successful outcomes with whole gland therapy. Tissue Change Monitoring (TCM) has inspired me to modify the treatment on whole glands to lessen the risk of complications.

It is impressive that many of my patients have done the math and found HIFU to be a relative bargain due their ability to go right back to work. When one considers the convalescent period after radical prostatectomy, or the weeks involved with radiation therapy, not mention the higher side effect profile with both, the cost of HIFU becomes less an obstacle to choosing this innovative option. I am very enthusiastic about teaching this procedure to my colleagues going forward.

To learn more about or be connected to Dr. Lazar please call 1-866-553-1629 or email nurse@internationalhifu.com.

HIgh Intensity Focused Ultrasound

Patients diagnosed with prostate cancer are faced with treatment options. The historical
remedies—radiation therapy, surgery, hormonal therapy, chemotherapy and freezing the cancerous gland—have risks and negative side effects, especially incontinence and impotence. A new technology, however, is coming of age in its ability to diminish these risks and side effects. This nonsurgical outpatient option—high intensity focused ultrasound (HIFU)—takes approximately one to four hours to perform, depending on prostate
size, and has a relatively short recovery period.

With HIFU, most patients are up and walking around within two to three hours and may resume normal activities within a couple of days, with minimal discomfort.1 HIFU patients
also experience fewer side effects than those receiving traditional prostate treatments.2 During the first two weeks after the procedure, patients may experience mild urinary symptoms, such as frequency and/or urgency to void. In the first three months, patients may also pass an occasional small amount of blood or mucus-like materials, which is normal.

HIFU is radiation-free. Unlike radiation, ultrasound energy is non-ionizing, meaning that it will not harm any tissue outside of the targeted area. (Damaged tissue could set the stage for a possible cancer recurrence.) Because HIFU is performed without an incision, patients don’t experience blood loss and can usually be discharged after recovery from the general or epidural anesthesia. Furthermore, because HIFU uses ultrasound rather than radiation to destroy targeted tissue, the procedure can be repeated if necessary.

During the HIFU procedure, all or part of the prostate is ablated, including the prostatic urethra. The urethra is derived from a different type of tissue (bladder squamous-type epithelium) than the prostate (glandular, fibrotic and muscular) and does restore itself with time. A suprapubic or penile catheter is inserted for one to three weeks until prostate swelling resolves.

The machine used to transmit HIFU uses a computer-controlled device designed for transrectal delivery of energy to the prostate. It features a fully integrated probe
with dual treatment transducers that move robotically to follow the physician’s precise treatment plan.

Urologists around the globe, as well as those in U.S. involved in clinical trials, have been using HIFU to treat localized prostate cancer and recurrent prostate cancer/radiation failure with both focal therapy and whole-gland therapy. Worldwide, over 7,000 HIFU prostate treatments have been performed to date.

Accurate imaging is a key component. The technology makes use of integrated biplanar ultrasound imaging for real-time treatment monitoring, treatment planning, and pre- and post-treatment imaging of the prostate. Precise focusing of ultrasound energy during HIFU treatment rapidly elevates the temperature of the tissue to 90 degrees Celsius in the focal zone, while intervening tissue between the transducer and the focal zone is kept
at a safe temperature.

The result of HIFU therapy is an accurate and repeatable lesion at the target sites that are monitored in real time by the treating physician. All treatment zones are pre-planned and checked by the physician prior to HIFU treatment. The procedure allows for a customizable treatment plan tailored to each patient’s prostate cancer diagnosis. The imaging capabilities of the technology also allows for the identification of vital structures, such as the prostate capsule, seminal vesicles, rectal wall, and the physiological location of neurovascular bundles.

A radio frequency (RF) signal is sent to a treatment site prior to delivery of HIFU, and then another signal is sent after delivery to the same site. A sophisticated tissue-change monitoring system calculates the change that took place and displays it on the screen by
quantifying tissue changes based on a comparison of RF ultrasound pulseecho signals at each treatment site. This tracking procedure shows results using real-time ultrasound imaging aided by advanced tissue-change monitoring software.

An integrated Doppler feature in the transrectal probe provides an additional safeguard during treatment. This feature helps physicians identify vital structures that need to be preserved to avoid problems with urinary continence and sexual function. With HIFU’s
precisely targeted accuracy, there is less damage to the surrounding area, such as the muscle controlling urine flow and the nerves controlling erections.

HIFU technology remains investigational in the United States, but it is being studied for the treatment of prostate cancer in U.S. clinical trials. The technology has been approved in more than 30 other countries in Europe, South America and North America (Canada and Mexico). The Food & Drug Administration has scheduled a panel review of HIFU technology for early October that may result in a decision within 60 days.

By | May 7th, 2015|Alternative Treatment for Prostate Cancer, Dr. Michael Lazar, HIFU, Prostate Cancer, Uncategorized|Comments Off on HIgh Intensity Focused Ultrasound

Santa Rosa doctor journeys outside U.S. to practice new prostate cancer treatment

Dr-michael-lazar
When Dr. Michael Lazar makes weekend trips to Puerto Vallarta, Mexico, it’s for business — to use a high-tech device to treat men with prostate cancer.

Lazar, a Santa Rosa urologist for 30 years, is the only Northern California physician regularly treating patients with high-intensity focused ultrasound, known as HIFU, which is currently not approved for use in the United States.

But HIFU, used for a decade or more in other countries, is “hands-down,” Lazar said, the best treatment for prostate cancer, the most non-skin common cancer in men and second only to lung cancer in deaths.

HIFU is the only non-invasive and radiation-free treatment for the disease, which was diagnosed in nearly 240,000 American men last year and caused almost 30,000 deaths, Lazar said.

The process uses an “acoustic scalpel” of high-intensity sound waves focused to a tiny point and heated to 200 degrees Fahrenheit, literally burning away cancerous growth and leaving all other tissues untouched.

Lazar, who’s performed about 100 HIFU procedures since 2007, said the success rate — in terms of keeping patients cancer-free — is comparable to the conventional treatments: surgery, radiation or cryotherapy.

The payoff, he said, is that HIFU is “substantially less likely” to result in impotence or incontinence, the major risks of the other treatments.

Radiation, in addition, is a prolonged, tiring treatment that also risks cancer due to chromosome mutation and internal burns.

HIFU procedures are relatively quick, and patients, following recovery from anesthesia, experience little pain or bleeding because the ultrasound waves seal off nerves and blood vessels, Lazar said.

“You’re on your feet, you can go out and eat” the evening after surgery, he said.

Temple Smith of Cloverdale had a HIFU procedure done by Lazar more than five years ago and said he remains cancer-free. Smith’s uncle died of prostate cancer and his brother, who had surgery to remove his prostate, became incontinent.

“If you have prostate cancer and the resources to get the HIFU treatment, get it done,” Smith said.

Another patient, Harlow Plimpton of San Francisco, had the treatment in 2011 and experienced no side-effects.

“Since then I’ve been looking for a downside, but frankly I haven’t found any,” Plimpton said.

Cost is the rub, Lazar said.

HIFU costs $25,000 and may or may not be covered by insurance. “It’s a leap of faith,” Lazar said, explaining that patients pay for the procedure and take the chance it will be covered.

Many of his patients obtain a home equity loan to pay for the treatment, he said.

HIFU has been performed for years in Japan, Europe and Canada, and is approved for use in more than 30 countries. Closest to home, it is available in Puerto Vallarta and Cancun in Mexico, as well as Nassau, Bermuda, Toronto and Montreal.

Hospital San Javier in Puerto Vallarta, where Lazar works seven or eight weekends year, is accredited by the Joint Commission, which accredits U.S. hospitals.

In the U.S., HIFU is pending approval by the Food and Drug Administration, which has accepted the results of a clinical trial involving 100 American patients whose prostate cancer returned following radiation treatment.

HIFU had a 70 percent success rate in the trial, said Lazar, who was a proctor during the trial.

Dr. Stephen Scionti, a urologist and prostate cancer expert in Framingham, Mass., said that HIFU, under the right conditions, “offers the best opportunity for excellent results” in treating prostate cancer.

HIFU also has potential for treating cancers of the kidney, uterus, bladder and liver, Scionti said. It has the potential to treat breast cancer, Lazar said.

The FDA’s decision on HIFU is expected within year. Approval in the U.S. is a prolonged, expensive process, and the agency will not accept results from other countries, Lazar said.

The Next Generation of Prostate Cancer Treatment: High Intensity Focused Ultrasound

by Michael J. Lazar, MD

Prostate cancer is the leading form of solid organ cancer in the U.S. and the fourth most common form of cancer in the world. According to the U.S. National Institutes of Health, the U.S. had more than 27,000 deaths in 2009 due to prostate cancer, which usually strikes older men. Those who have been diagnosed with prostate cancer and have explored treatment options have been faced with some difficult choices. Which treatment is likely to be most effective? Which has the fewest associated risks? What are the side effects?

Traditional treatments include: radiation therapy, surgery, freezing the cancerous gland, hormonal therapy and chemotherapy. Physicians base treatment recommendations on many factors such as tumor size, spread of the disease and the patient’s medical status and history. Fortunately advances in research and technology have produced another non-invasive option with relatively few side effects: High Intensity Focused Ultrasound, or HIFU. As with other treatment options, urologists carefully screen patients before recommending this option to make sure they are an appropriate candidate for HIFU.

HIFU treatment is advanced medical technology that uses ultrasound to rapidly and precisely apply heat at a level that is lethal to prostate tissue. It destroys the entire prostate gland or focuses only on the cancerous portion of it. This highly localized treatment leaves the surrounding tissue unharmed.

With this quick, non-surgical outpatient procedure, patients usually have a spinal anesthesia. Because the procedure is performed without an incision, patients do not experience blood loss, typically regain normal mobility within only a few hours of treatment with minimal discomfort usually treatable without pain killers, and can return to normal activity within a few days. With HIFU, the negative side-effects of traditional treatments are greatly diminished. Since there is less damage to the surrounding area, such as the muscle controlling urine flow and the nerves controlling erections, negative side effects are minimized, and patients can return to a normal lifestyle.

The oncological results of HIFU are broadly comparable to radical prostatectomy, but the patient benefits outweigh those of other treatment options. In addition, HIFU is the only non-invasive prostate cancer therapy that uses clean (or non-ionizing) energy, allowing patients to repeat treatments if necessary without collateral tissue damage.

With Sonablate® 500 technology, developed by Focus Surgery, Inc. of Indianapolis, Indiana, the doctor is able to obtain real-time ultrasound images of the prostate and surrounding areas. From these images, the surgeon determines precisely where the High Intensity Focused Ultrasound energy will be delivered. The technology then allows the surgeon to visually direct the treatment and destroy the targeted gland or selected portions. This is the only non-radiation technology that requires no direct contact with the target organ.

HIFU technology has been extensively studied and has advanced to point that it effectively represents the next generation of prostate cancer treatment. No other form of treatment allows the surgeon the control to so precisely pinpoint the targeted area and effectively ablate it without damaging the surrounding tissue.

Combo Chemo + Immune Therapy Shows Promise In Mice

Reported in AUA Daily Scope, from The Telegraph (British magazine): Combination chemotherapy and immune therapy resulted in enhanced immune system activation against widespread human prostate cancer that had been implanted in mice. The metastatic disease was “wiped out”.

This is exciting, but it remains to be seen whether similar results will be seen in humans. Over the years, many promising animal model therapies have not translated into useful treatments in people. For all our similarities to animals, we are much more complex, and their corresponding immune systems may be stronger than ours through natural selection over time.

By | May 1st, 2015|Alternative Treatment for Prostate Cancer, Dr. Michael Lazar, HIFU, Prostate Cancer, Uncategorized|Comments Off on Combo Chemo + Immune Therapy Shows Promise In Mice