Dr. Leff is featured on International HIFU.
Dr. Leff talking HIFU onThe Medical Show featured on 790 KABC
The EDAP TMS SA is the worldwide leader when it comes to therapeutic ultrasound. The company recently appointed Bill Brown to be its US Senior Sales Manager. With the addition of Mr. Brown, EDAP’s US-based team aims to strengthen its Sonolith i-move extracorporeal lithotripsy system (ESWL) market penetration, expand its lithotripsy sales in the US, and prepare for the FDA approval of its Ablatherm-HIFU device or High Intensity Focused Ultrasound machine.
Mr. Brown possesses 20 years of experience in the medical field as well as 10+ years of success selling lithotripsy machines in the US. He has close connections with the US urology group and EDAP can benefit from his knowledge and expertise of the US market and his relationships involving its significant opinion leaders.
EDAP TMS CEO Marc Oczachowski is pleased to have Bill on its team. Bill’s proven and successful track record in the US sales of lithotripsy devices can help the company’s Sonolith i-move machine penetrate the US market. Oczachowski stated that they are focused on introducing the product to the US market. He added that they are also preparing to penetrate the US prostate cancer market once approval for Ablatherm-HIFU is given.
Mr. Brown stated that he welcomes this new challenge in his career. He stated that he is excited for EDAP’s Sonolith i-move device that is capable of treating urinary stones with its superb ultrasound localization. Mr. Brown indicated that he is looking forward to assisting EDAP in its US expansion through the company’s HIFU and lithotripsy technological devices.
The Sonolith i-move device is a compact lithotripter that uses innovative infrared stereo-vision system of urinary stone ultrasound localization using a three-dimensional real-time approach. It comes with several modular configurations and is set to replace the early lithotripter Sonolith Praktis model and complements EDAP’s Sonolith I-sys lithotripter, which combines x-ray with the ultrasound localization set-up. The Sonolith i-move product received its European approval last April 2010, its Japanese approval last June 2011, as well as its clearance for the US market last August 2011.
The company will be filing the PMA or Premarket Approval with US FDA during the last quarter of the year 2012.
EDAP develops and sells the Ablatherm, its most innovative, clinically proven option for the high-intensity focused ultrasound or HIFU treatment of localized prostate cancer. The treatment is minimally invasive and comes with minimal side effects. The treatment is recommended for use on patients suffering from localized prostate cancer that failed the radiotherapy treatment and wish to try a different treatment option, or are no longer candidates for surgical procedure. In Europe, Ablatherm HIFU was approved for treatment of prostate cancer. Presently it is undergoing clinical trial evaluation. EDAP Company is developing the technology for possible treatment of specific tumor types. EDAP is also responsible for the introduction and commercialization of medical equipment capable of treating urinary tract stones with the use of ESWL or extra-corporeal shockwave lithotripsy.
Today, Royal Philips Electronics and Utrecht University Medical Center announced the start of the pilot clinical trial to evaluate new breast cancer treatment using MR-HIFU or MR-guided High Intensity Focused Ultrasound.
To assist the study, Philips developed an investigational system for the female breast anatomy. This system has been used in the trial to treat the first patient.
Through heating, the MR-HIFU technology has a potential to destroy the tumors in a non-invasive way while still in the body. The treatment emits sound energy directly to the tumor and burns up thereby generating heat. The technique can induce more than 65 degrees Celsius of tissue temperature, a temperature high enough to eliminate tumor cells but not the surrounding tissues. An MRI or Magnetic Resonance Imaging can capture real time structural images of the soft tissues making it possible for HIFU beam to accurately penetrate the tumor. The MRI can also extract temperatures of the local tissues, which is necessary to be able to control the temperature to be applied.
For the study, the UMC Utrecht works hand-in-hand with Diakonessenhuis Hospital in Netherlands where patients are enrolled. The HIFU treatment is done under sedation or local anesthesia. After the treatment, a customary surgical procedure is performed to check how precise the treatment is. The study aims to evaluate the quality of the image taken through MR-HIFU system and the technique’s precision and safety during its application.
This pilot trial targets patients suffering from breast tumors without metastasis. These patients are included in the group that makes up approximately a fourth of Netherlands’ breast cancer sufferers, according to Dr. Maurice van den Bosch, research leader and interventional radiologist at UMC Utrecht. He added that the MR-HIFU technology is non-invasive, keeping the patient’s skin intact.
General Manager of the MR-Therapy at the Philips Healthcare, Falko Busse stated that the MR-HIFU technology can become one powerful tool for physicians. Its benefits have been shown treating benign uterus tumors. Instead of performing surgical procedure, patients are provided this non-invasive alternative which has a lower complication risk and offers faster recovery. At this time, the technology is being developed for use in advanced cancer care.
If anyone can speak about prostate cancer, it is Michael King. Michael has survived prostate cancer for 5 years. His story began in May of 2007 during a routine physical, when Michael’s doctor noticed a “lump” and referred him to a urologist. Upon further analysis, it was discovered that he did have prostate cancer, and unfortunately for Michael it had spread to his left thigh as well.
Michael shares his experience while awaiting additional test results from the bone marrow test on his right thigh. He visited the cemetery to see if a plot was available close to his mother’s grave. He fed the ducks in a local park with his granddaughter. “During those moments, I was thinking I don’t really have much time left”, he said.
Today, as a survivor, Michael King devotes much of his time to make men more aware of this devastating illness, and more importantly how to prevent it. He speaks to men and encourages them to see their doctor, to have that exam. He often wears his “Blue Cure” T-shirt on which is printed the words “Not just an old man’s cancer”. He fully understands that men don’t get checked because they hate the thought of going to the doctor and receiving a rectal exam, but he is all too familiar as to why they should. The truth is most guys simply have the attitude to “fix it themselves”.
Michael is not alone in his quest. A FREE screening for prostate cancer is available at IU Health Ball memorial Hospital on Thursday. A free seminar on Wednesday, Sept. 26th is also available.
Urologist Jeff Ulrich (Urology Associates) also hopes that men will take advantage of the free screening and seminar. He would like to see prostate cancer become as publicly aware as breast cancer has become and to receive the same level of effort to prevent the disease. Dr. Ulrich suggests that if you are unable to attend the free screening this week that you should consult with your family physician as to whether you should be screened.
Michael’s words of wisdom are simple, “just get checked”.
Six years ago, a retrovirus by the name of XMRV, thought to have been derived from prostate cancer cells, was actually a result of a contagion. What was considered as a trademark of a genetic material in prostate cancer tissue cells turned out to be a result of lab contamination; the XMRV virus was conceptualized to be the basis of prostate cancer among the public and had helped raise theories of treating the cancer through XMRV blocking antiviral medicine.
Recent verdicts conclude that the retrovirus was not an imprint of a genetic material but a result of contaminated cells in the laboratory. Other new findings have also proven that XMRV was not the cause of infection in prostate cancer patients. Researchers, in another study, state that recently performed forensic investigations of the prostate cancer tissue samples and other laboratory experiments prove the fact that XMRV traces was not the cause of prostate cancer. Latest technologies and lab tools were used to conduct these forensic studies.
Samples of both the XMRV virus, from other cells, and prostate cancer tissue samples were handled in a laboratory. Somehow the virus samples had managed to find their way to and contaminate the cancer tissue samples. Scientists and researchers of the lab had examined the tools and methods used to aid this finding. They voiced that if these technologies were available when the first theories of XMRV was linked with prostate cancer cells, they would have discovered the contamination much earlier.
Earlier, there were researches that connected XMRV viruses with another common ailment- chronic fatigue. Tissue samples from patients suffering from chronic fatigue syndrome had also links to XMRV virus, but this discovery has been withdrawn. XMRV’s link to prostate cancer built new hope of curing the disease. The later uncovering of this being an incident of lab pollution has disdained hopes of many.
Ed Randall is the host of “Ed Randall’s Talking Baseball” on WFAN radio and also serves as the post game analyst for the Yankees on WWOR-TV. His charity, Fans for the Cure organization and Greenwich Hospital, have joined forces to promote more prostate screenings for men and increase awareness of the deadly disease.
Randall was extremely pleased with the turn out when hundreds of men showed up at the Helmsley Medical building to have their PSA test performed. A prostate cancer survivor himself, he made a personal appearance at Greenwich Hospital on Thursday to meet with his fans and to promote this most worthy cause. “There’s a huge chance of getting cured if prostate cancer is detected early and consequently, if it’s treated right away. It’s very nice seeing all of them today, I mean, everyone should be aware that prostate cancer is a menace if we leave it unchecked.”
Speaking about his own personal Giant Cheap Airblown Inflatable Santa Cane ordeal with prostate cancer, Randall stated that “I was 47 during that time and displayed no symptoms. I was merely out for a standard physical check and the following day, my doctor informed me that my PSA was abnormally high. It was really shocking for me because I really didn’t feel anything prior to that and showed no symptoms. I guess prostate cancer is really just like that – it’s like a ticking time bomb for millions of men out there.”
Randall has now been in remission for years after successful treatment of the disease. “In remission – these are probably two of my most favorite words right now,” he said.
Steve Corman, the man in charge of the prostate cancer education program at Greenwich Hospital said “With the introduction of the PSA test about two decades ago, it gave men an early warning sign that the cancer cells could be present. Right now, the average detection age has dropped by ten years and we are more informed bacause of these kinds of tests.”
This would be alarming if it was true, but sadly the fact that many people don’t know the answer to this question highlights just how little the general public knows about this, deadly disease. Surveys show that in the United States and Canada, almost 20% of respondents answered affirmative to the above question, exposing how much more need to be done to highlight this threat.
The answer of course, is that women cannot get prostate cancer; however, that doesn’t mean to say they are unaffected by the issue.
Perhaps the more appropriate point to discuss here is NOT whether women can get prostate cancer, but how the disease affects her when a loved one or partner is diagnosed with the condition. People should remember that not only do the patients have to suffer the stress and worry of the situation, as well as all the lifestyle adjustments or changes etc that comes when one is diagnosed with this disease. Spouses or partners equally carry this burden. Support among the other members of the family, most especially the other half, is often vital if the patient is to come through the situation. As such, communication is key.
Being open and honest about the real condition of his health, a man can – figuratively speaking – tear down the walls of getting the disease in the first place. Just like what the old saying goes: Prevention is better than the cure. This doesn’t only relate to having regular medical check-ups and discussing issues with the doctor, and ensuring that everything is actually being laid down for proper record; but, it is also necessary for the man to speak of his feelings, and what he is thinking about his condition, so his partner can help him shoulder the emotional burden.
The first thing that pops into the mind of a man diagnosed with prostate cancer is the possible treatment options. Doctors will often suggest radical remedies for dealing with the disease, such as radiation, hormone therapy, and worse, prostatectomy.
Treatments as drastic as the ones listed above will most likely have devastating side effects after being utilized on the patient. A study conducted by Prostate Cancer Intervention Versus Observation Trial (PIVOT) shows that one of the many post-surgery impacts include erectile dysfunction, experienced by four out of five men, and incontinence, which affects one out of six.
What’s worse, countless urologists actually recommend these extreme operations to almost all of their patients, including the ones suffering from low-risk localized prostate cancer.
Fortunately, PIVOT recently released a study which actually shows that surgically treating the malady isn’t as effective as everyone thought it once was. During the years 1994 and 2002, 731 men suffering from localized prostate cancer in North America were randomly assigned to undergo prostatectomy and watchful waiting.
Ten years later, a follow-up research was conducted on the two control groups, and the results were astonishing: there was no significant difference in the survival rates of the crowd which underwent surgery in comparison to those who took no treatment at all (aside from a few tests to check on the disease’s progression.)
This completely debunks surgery as a reliable treatment for such an ailment – not only does it yield similar results to watchful waiting, but it significantly places the patient at risk for erectile dysfunction and incontinence.
On the other hand, though this disorder usually spreads at a very slow rate, it’s possible for it to develop into a more aggressive variation. If preventive action must be taken, High Intensity Focused Ultrasound (HIFU) is a new non-invasive procedure that’s currently being recommended as a highly-preferred treatment.
HIFU utilizes sound waves which are converted to heat at point (like a magnifying glass focuses energy) to safely pass through healthy tissue, and destroy the prostate’s infected portions only. Not only is HIFU safer, but it also greatly reduces chances for developing any side effects post-operation.
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Views on prostate cancer treatment options have significantly changed. Patients are now becoming more aware of information pertaining to the disorder, and have realized that radical remedies such as prostatectomy and radiation therapy bare way too many incapacitating side effects that do have the tendency to outweigh the actual condition itself.
The hazards associated with these procedures to combat the malady has inspired (out of good will, desire for huge profits, or both) many companies and urologists to search for safer alternatives. With that said, a new drug known as Xtandi, is one of the latest treatments for dealing with the ailment.
Created by the San Francisco pharmaceutical firm Medivation along with a Japanese company known as Astellas Pharma, this drug showed impressive results during clinical trials. Based on these studies, men who took Xtandi lived five months longer than those who took a placebo.
This revolutionary medication passed the FDA’s testing review program with flying colors as well – while new medicines are required to undergo careful testing for a period of six-months before approval, Xtandi actually got approved in three months’ time.
As promising as this drug is, the cost for receiving treatment “Xtandi-style” will rack up a bill of $7,450 a month. This could potentially strain the healthcare system by adding billions of dollars to medical expenditures.
Regardless, a dying man would most likely be willing to pay any amount to extend his life-expectancy by several months.
On the other hand, Xtandi comes with a bundle of potential side effects as well. The most common reactions from this drug includes headaches, insomnia, fatigue, spinal cord compression, muscular weakness, blood in urine, anxiety and high blood pressure.
Nevertheless, technology and scientific research is constantly giving birth to better and safer non-invasive prostate cancer treatments, such as High Intensity Focused Ultrasound (HIFU.) Since this procedure uses sounds waves to pinpoint and destroy infected tissues only, post-operation side effects are greatly minimized, and even completely eliminated.
Doctors have the tendency to recommend extreme solutions for low-risk forms of this cancer. It’s always best to thoroughly research every possible option for dealing with this disease before ultimately choosing one.
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