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Focused ultrasound therapy is here: Are you ready?

A new, highly disruptive therapeutic technology called focused ultrasound is transforming – standards of care around the globe.

In this series, we asked speakers at the Milken Institute Global Conference to answer: How does one build a meaningful life in the age of technological disruption? Join the conversation by writing your own article here and including #MIGlobal.

A new, highly disruptive therapeutic technology called focused ultrasound is slowly but definitively influencing – and on the verge of transforming – standards of care around the globe. This game-changing, noninvasive treatment option for a wide variety of serious medical disorders has the potential to be an alternative or adjunct to surgery, radiation therapy, drug delivery, and cancer immunotherapy, while decreasing cost of care and improving outcomes for millions worldwide. If it sounds too good to be true, it isn’t. Focused ultrasound has been named one of the 50 greatest inventions by TIME magazine, credited with “changing medicine” by Fortune magazine, and just this month was named a top 10 clinical research achievement of 2016 by the Washington, DC-based Clinical Research Forum.

Innovation breeds innovation, but also, modification. Once fully developed and implemented – months to decades from now depending on the clinical indication – focused ultrasound will have widespread impact on healthcare constituents including physicians, treatment facilities, and manufacturers of legacy therapy equipment, among others. This process has in fact already begun. Focused ultrasound will also bring about major change to referral patterns, treatment paradigms, practice guidelines, and equipment acquisition as the technology transitions to a mainstream therapy.

In order to benefit from these changes, stakeholders – perhaps your organization or yourself – must be prepared to enter the field early on. And for many, “early on” means now.

What is focused ultrasound?

Focused ultrasound, or FUS, uses ultrasonic energy to target tissue deep in the body without incisions or radiation. With more than 22 regulatory approvals around the world to date, including five by the US Food and Drug Administration and more than 50 additional clinical indications in various (mostly early) stages of development, FUS may treat a disparate range of diseases including: Parkinson’s; Alzheimer’s; depression; obsessive-compulsive disorder; arthritis; back pain; and, tumors of the brain, breast, prostate, liver and pancreas. It has the potential to be as revolutionary to therapy as magnetic resonance scanning (MRI) has been to diagnosis.

The basic principle is analogous to using a magnifying glass to focus beams of sunlight on a single point to burn a hole in a leaf. With focused ultrasound, multiple intersecting beams of ultrasound energy are concentrated on a target deep in the body with extreme precision and accuracy (sparing adjacent normal tissue). Where each individual beam passes through the body there is no effect. But at the focal point where the beams converge, the focused ultrasound energy induces a variety of biologic effects including: destroying tissue, stimulating the body’s immune response, and enhancing the delivery of drugs. The location of the focal point and the treatment effect is guided and controlled in real time by ultrasound or MR imaging.

Besides patients, who will focused ultrasound affect?

Three healthcare industry groups will be particularly impacted by the widespread adoption of FUS. First, consider the manufacturers of legacy therapy equipment (e.g., linear accelerators for radiation therapy and robotic surgical devices) to which focused ultrasound is an existential threat. These manufacturers would be wise to begin redistributing resources from their traditional product lines now to invest in new FUS technology. Such companies are in fact well-positioned to do so as they already have the functioning sales, marketing, support and distribution channels in place. It is clear that once the medical community broadly understands the capabilities of focused ultrasound, many legacy therapy equipment options will quickly become obsolete.

Physicians will also benefit from entering the FUS field sooner rather than later. In the current environment, many physicians – not all – can unfortunately be motivated by money, time and outcome, in that order. As focused ultrasound advances, they will need to become educated and trained in utilizing FUS technology, and adopt it as part of their practice, even in cases where the economics on a per procedure basis are less favorable than current therapy alternatives. If they choose not to, patients seeking FUS – and demand is growing – will simply find a physician who will. Of note: focused ultrasound centers worldwide are reporting a backlog of several hundred essential tremor patients desiring FUS, and a nationwide study of nearly 1,000 US uterine fibroid sufferers (published in the October 2013 issues of both the American Journal of Obstetrics and Gynecology and the Journal of Women’s Health) found that when presented with fibroid treatment descriptions, the majority surveyed (60%) rated focused ultrasound as their top treatment choice.

Finally, now is also the time for hospitals and clinics to consider becoming early adopters of focused ultrasound. Doing so will enhance their reputation as being on the leading edge of medical care, and will provide a competitive differential over institutions that have not yet acquired FUS technology (see above regarding patient demand and preference). Additionally, offering focused ultrasound will create a halo effect for the hospital or clinic when patients are referred for this cutting-edge treatment and found to not be a candidate; these patients will often choose to stay with the practice and receive an alternative treatment, increasing market share for the institution.

The future is now

We are all aware that medical device development and adoption occurs exponentially; with focused ultrasound we are right now at the beginning of the inflection point of the curve. Our goal is to treat hundreds of thousands of patients annually and we are well on our way, with 15,000 FUS treatments performed worldwide in 2014, approximately 25,000 treatments in 2015, and a more than double increase to 50,000-plus patients treated in 2016. In other words, focused ultrasound is about to evolve into a robust medical field, with the pace of research and development, publications, patient treatments and the number of device manufacturers all increasing rapidly in the past few years.

Still, there remains an enormous amount of work to be done, and many barriers to overcome, before the technology becomes a standard of care that can help millions of patients. But we are closer than ever. When the potential of focused ultrasound is realized and it becomes a mainstream therapy, it will result in changes that will benefit countless patients and impact physicians, payers/providers, manufacturers, hospitals/clinics, caretakers, etc., around the globe. It’s coming. It is reinventing care. Are you ready?

Find out more at www.fusfoundation.org

About the Author: Neal F. Kassell, M.D., is the founder and chairman of the Focused Ultrasound Foundation. He was a Professor of Neurosurgery at the University of Virginia from 1984 until 2016 and was the Co-Chairman of the department until 2006. He received both his undergraduate and medical education at the University of Pennsylvania. In April 2016, Dr. Kassell was appointed by Vice President Joe Biden to the National Cancer Institute’s Blue Ribbon Panel for Cancer Moonshot Initiative. Dr. Kassell has contributed more than 500 publications and book chapters to the literature and is a member of numerous medical societies in the United States and abroad.

The Focused Ultrasound Foundation is a medical research, education, and advocacy organization created as the catalyst to accelerate the development and adoption of FUS, shortening the time from laboratory research to widespread patient treatment. 

By | May 4th, 2017|HIFU, News, Prostate Cancer|0 Comments

HIFU: Prostate Cancer Treatment Has 97% Survival Rate

A prostate cancer treatment which is rarely offered on the NHS may give patients a 97% chance of survival after five years, a landmark study has suggested. The so-called “male lumpectomy” treatment works by treating just the prostate cancer tumor with High Intensity Focused Ultrasound (HIFU).

It is said to have “significantly fewer side effects” than traditional treatments and delivers high rates of cancer control. Prostate cancer is the most commonly diagnosed cancer in men, the second most common cause of cancer-related death in the US and the third most common cause in Europe. While already cleared by the US Food and Drug Administration (FDA), HIFU treatment is only available in very few centres in the NHS.

For more information about HIFU available in the U.S., to make an appointment call (707) 546-5553 or visit our at: www.californiahifu.com

Read the full story …

By | March 24th, 2016|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