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Teleflex Incorporated Completes Acquisition of NeoTract

Wayne, PA — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies designed to improve the health and quality of people’s lives, announced today the completion of its previously announced acquisition of NeoTract, Inc.

On September 5, 2017, the two companies announced a definitive agreement for Teleflex to acquire NeoTract in a transaction valued at up to $1.1 billion. Under the terms of the agreement, Teleflex acquired NeoTract for an upfront cash payment of $725 million at closing, and has agreed to pay up to an additional $375 million upon the achievement of certain commercial milestones related to sales through the end of 2020.

Founded in 2004, NeoTract is a privately-held medical device company that has developed and commercialized the FDA-cleared UroLift® System, a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia, or BPH. Performed primarily through a transurethral outpatient procedure, the UroLift® System delivers permanent implants that hold open the urethra, reducing the prostate obstruction without cutting, heating, or removing prostate tissue.

Teleflex will provide additional details on the transaction, including an update to its fiscal year 2017 financial outlook as a result of this transaction, on its third quarter 2017 investor conference call.

ABOUT TELEFLEX INCORPORATED

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson RCI®, LMA®, Pilling®, Rusch® and Weck® – trusted brands united by a common sense of purpose.

ABOUT NEOTRACT, INC.

NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.

Help for Men With Enlarged Prostates

Enlarged prostates begin affecting about 50 percent of men in their 50s, and that number rises with age. As the prostate presses on the urethra, it can cause complications with urination, including slow or weak stream, the urgent need to urinate night and day, and accidental urination. Traditional treatments, typically medication or surgery, often come with undesirable side effects such as dizziness, headaches and significant issues with sexual dysfunction, which often makes men hesitant to pursue treatment.

As we celebrate men’s health month in June, we are taking a look at a minimally invasive procedure that is growing in popularity with urologists, some of whom are even using it for themselves. The prostatic urethral lift (PUL) procedure, known by the trade name UroLift, takes less than an hour and can be performed under local anesthesia in the doctor’s office.

Small UroLift implants are permanently placed to lift or hold the enlarged prostate tissue out of the way and increase the opening of the urethra to provide immediate symptom relief. The procedure does not involve cutting, heating or removal of prostate tissue.

 

The medical term for noncancerous enlarged prostate is benign prostatic hyperplasia (BPH), and it can interfere with sleep patterns and quality of daily life. A study published in the Journal of Urology stated that the condition affects 50 percent of men ages 51 to 60, and that the number increases to 80 percent by the time they reach their 70s. The UroLift System, which the FDA approved in 2013, involves inserting tiny implants that push the prostate off the urethra; UroLift’s producer, NeoTract Inc., likens it to tie-backs that hold window curtains open.  

Clinical data from a 206-patient randomized controlled study showed that men with enlarged prostates receiving UroLift implants reported rapid and durable improvement in their symptoms and urinary flow without compromising sexual function. Recovery is also faster than with traditional surgery, called transurethral resection (TURP), with minimal side effects, according to NeoTract. 

“This product has been a game changer for us,” says Gregg R. Eure, a urologist in Virginia Beach, Va., and assistant professor of urology at Eastern Virginia Medical School. “It is filling a niche that we haven’t had before. It takes less than one hour, and they are back to their regular routine quickly. It makes it very appealing to patients.” 

In the past, men would look at surgery as a last resort and wouldn’t do it until their enlarged prostate was so bad that they needed a catheter, Eure says. “But now they can address the symptoms earlier and enjoy the benefits longer.” In the NeoTract study, 14 percent of patients had to have additional treatment after the initial UroLift procedure, and there is some evidence that the traditional surgery may still offer better long-term urinary tract improvement. But the ease of the UroLift procedure and the minimal side effects still make it the better option for many patients, according to Eure, who participated in the procedure’s research trials.  

Over two years, Eure has done the procedure on nearly 200 patients with strong results, and he expects its popularity to rise now that it is reimbursed by Medicare and most other insurance plans. Other urologists agree. 

“I’ve followed the literature on the system from around the time it was FDA approved and became curious about it because it is a complete departure from the past,” says Peter J. Walter, a urologist in Jamestown, N.Y. “Surgery required cutting or heating and burning tissue, but this is a totally different way of managing the tissue. It is gently compressed and held in place by small tailored implants.”

Walter, an adviser to NeoTract, started using UroLift in his practice in 2015 and has performed the procedure on about 200 patients. Eventually, he started considering the procedure for himself. “I’m a 55-year-old man and was having symptoms [of BPH] myself and had to make a personal choice. I was not excited about medications because of the side effects, so I had [the UroLift] done in April of 2016 and it’s been great because my symptoms remarkably improved and I had no side effects.”

Walter is also relieved that he doesn’t have to take a pill every day, which he says is a bonus. “Some of my patients might be on 25 or 30 medications for different conditions, and who knows how those are all interacting,” he says.  

Not every patient is a perfect fit for the procedure due to anatomical differences with the prostate. If patients are interested they should speak with their primary care physician or urologist to get more information. A urologist may have more specific information about the procedure, Eure says. “As a urologist it is nice to feel confident that you are educating patients on a product that can really help them. You can see the change that it makes in their lives.”

Originally posted on aarp.org

NeoTract Inc. Announces Positive Five-Year Results for Minimally Invasive UroLift® System at American Urological Association 2017 Meeting

Speaking on the 5-Year L.I.F.T. data at AUA 2017

PLEASANTON, Calif. and Boston – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced presentation of the five-year results of the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift® System as a treatment for patients with symptomatic benign prostatic hyperplasia (BPH).  

Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas and co-principal investigator for the L.I.F.T. clinical program, presented the five-year results for the first time to a U.S. audience at the 112th annual American Urological Association meeting in Boston.

Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:

  • A highly tolerable, minimally invasive procedural experience;
  • Rapid reduction of symptoms after the procedure while preserving sexual function;
  • Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak   urinary flow rate) remaining 36% and 44% improved from baseline, respectively;
  • Quality of life (QoL) score improvement of 50% over five years;
  • A durable treatment with a low retreatment rate of 2-3% per year.

“The UroLift System has now been proven as a minimally invasive alternative to medication that offers sustained, reliable relief for patients,” said Dr. Steven Gange of Summit Urology Group in Salt Lake City, UT, who treated numerous patients as a part of the L.I.F.T. clinical trial. “The procedure itself can be performed efficiently by a trained urologist, with little need for anesthetics or pain medication. It involves no cutting, heating, or removal of tissue, and results are evident immediately. Healing and recovery are swift, with patients experiencing symptom relief and improved quality of life within a matter of days or weeks, and sustained similar results after five years. I truly believe the UroLift System is a game-changer for the field of urology.”

“We are excited to share this excellent long-term data with the attendees of AUA. The results continue to demonstrate the potential of the UroLift System to become the standard of care first-line treatment for patients with BPH. NeoTract has set the standard for robust BPH clinical data collection with global multi-site studies and proven durability and it’s an area we will continue to invest in,” said Dave Amerson, president and CEO, NeoTract, Inc. “We are honored to partner with urologists around the world to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option.”

Nearly 40 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life.

Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra.

About the UroLift System
The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia, Canada, Mexico and South Korea. Learn more at www.UroLift.com.

About NeoTract
NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.

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1 Roehrborn, AUA 2017, Boston

 

another blog post from Dr Baum

TO SUBSCRIBE TO DR BAUM’ S BLOG VISIT https://neilbaum.wordpress.com/

 

Here’s another one I wrote about post micturition dribbling.  You are welcome to use it as well

 

It’s Not a Riddle if You Dribble – After Urination

Many of my patients who are in the 40s and older have a complaint that they dibble small volumes of urinate after they go to the bathroom.  It is especially an issue if the man’s wears khakis or light colored pants and the dribbling leaves a small tell-tale circle.  The condition can be a nuisance and cause embarrassment.  Although dribbling may occur in women, it is much more common in men.  The condition may occur at any age but is usually present in older men. 

PMD is due to a weakness of the muscles of the pelvic floor which surround the urethra. The pelvic floor muscles can be weakened by:

· Operations for an enlarged prostate

· Continual straining to empty the bowels especially when constipated

· Constant cough, for example, a smoker’s cough

· Obesity

· Nerve damage after a prostate operation for prostate cancer when the entire prostate gland is removed

· Lifting very heavy objects

Other signs of urinary difficulties are not normally present, although some men have symptoms such as urgency, frequency, hesitancy and straining.

Few men admit to having this problem but a great many suffer from it and are often badly embarrassed by it.

The Solution for Dribbling After Urination

There are three proven ways of dealing with this problem.  One is to perform pelvic floor exercises, referred to as Kegel exercises.  Pelvic floor muscle exercises or pelvic floor muscle rehabilitation can, if done correctly, help you improve your bladder and bowel control and resolve or improve leakage. They can also be used to help you if you already have symptoms of pelvic floor weakness. When a muscle is not exercised it will weaken through lack of use. Like any other muscles in the body, the more you use and exercise them, the stronger the muscles will be. The pelvic floor muscles are no exception.   (Please go to my website and look at the article on Kegel exercises) 

The second approach is to push the last few drops of urine from the urethra with the fingers before the final shake of the penis.  To push the last remaining drops of urine from the urethra the technique is as follows:

1.     After passing urine, wait for a few seconds to allow the bladder to empty

2.     Place the fingertips of the left hand three finger-breadths behind the scrotum and apply gentle pressure

3.     Keeping the pressure in the mid line, gently but positively draw the fingers forwards towards the base of the penis under the scrotum

4.     This pushes the urine forward into the penile urethra from where it can be emptied by shaking or squeezing in the usual way

5.     Before leaving the toilet, repeat the technique twice to ensure that the urethra is completely empty.

And finally, men who have dribbling need to know that they must stand at the toilet for several seconds longer than when they were much younger.  Usually standing at the toilet for 15-20 additional seconds allows the final drops of urine in the urethra, the tube in the penis that transports urine from the bladder to the outside of the body. 

A few of my patients who have had the UroLift procedure will notice some dribbling after the procedure.  This is usually a short-lived complaint and resolves without any treatment in just a few days after the procedure. 

 

Bottom Line: Dribbling after urination is a common condition that affects most middle aged men.  Don’t despair the dribble is not anything that requires treatment.  Just a few more seconds at the toilet and a few shakes and you’ll be cured!

Dr Neil Baum Opioid and Testosterone Blog Post

Neil is a good friend and highly respected colleague. I will periodically post from his blog.

Pain Pills Won’t Put Potency In Your Penis
by Dr. Neil Baum, Urologist, New Orleans

There’s an opioid epidemic in the United States as the number of prescriptions written for opioids has skyrocketed over the years. From 1991 to 2013, the total number of prescriptions written for opioid painkillers skyrocketed by 172%. It is estimated to cause nearly 40,000 deaths in the United States which is more than those people who died in car accidents each year.  Besides the risk of death and havoc on the user and his\her family, opioids cause a deficiency in testosterone which significantly impacts a man’s sexuality.

Testosterone deficiency is an underappreciated consequence of using opioids.

Understanding the risks and the potential treatment options available may help minimize the impact of opioids on testosterone levels. This blog will discuss the relationship between opioid use and testosterone deficiency.

Yes, it is true that opioids are well-known to be highly effective at managing pain. Also well-known is their negative impact on testosterone levels in men taking these potent painkillers.   Interestingly, even with the recognition of this phenomenon, this side effect of reducing testosterone remains an underappreciated consequence of treatment.

Testosterone deficiency can lead to serious health consequences. Symptoms include reduced libido, erectile dysfunction, osteoporosis and decreased bone density, fatigue, depressed mood, reduced muscle mass, poor concentration, and sleep disturbances. As such, testosterone deficiency also impacts the quality of life and may even be involved in the development of heart disease.

New Findings

In a large study a higher risk of low testosterone was found with opioids. Data revealed that men on long-acting opioids were significantly more likely to be testosterone deficient.

Treatment Options

The management of low testosterone levels in men taking opioids begins with the checking the symptoms of low T such as decreased sex drive, loss of energy, loss of bone and muscle mass and the confirmation with testosterone testing. However, monitoring of hypogonadism can be a challenge as patients may not necessarily report their symptoms.

Additionally, when possible, baseline serum testosterone levels should be obtained prior to initiating therapy with potent pain medications. Testosterone levels could then be recorded at regular intervals to monitor changes.

If a patient presents with opioid-induced low T, there are several possible treatment options that can be pursued. Strategies that allow for opioid reduction could be considered, such as the concomitant use of non-opioid pain medications. The good news is that discontinuing opioid therapy can result in the normalization of testosterone, with data suggesting recovery of symptoms may occur as fast as a few days to up to 1 month after stopping treatment. Unfortunately, this is an unlikely option for men suffering from chronic pain.

Lastly, testosterone replacement therapy is a viable option for some patients. Testosterone can be given via injections, topical gels, or pellets inserted beneath the skin to restore the normal level of testosterone that will improve the symptoms of low T.  Close monitoring by your doctor will help identify the development of low T levels. Men who are educated on this potential side effect of low T can also be active participants in helping to identify this complication. While several treatment options are available, the best course of action for treating hypogonadism will ultimately depend on symptoms and the blood level of testosterone.

Bottom Line:  Opioids can help with the control of pain but with the price of decreasing the testosterone level in men.  Men who use opioids should speak to their doctor about their symptoms of decrease in sex drive, loss of energy or loss of muscle mass are candidates for hormone replacement therapy.

 

New version of Tamsulosin in development

Miami-based Veru Healthcare has determined that its Tamsulosin Delayed Release Sachet (DRS) for men with benign prostatic hyperplasia (BPH) has a similar biological profile to Flomax.

The announcement comes after Veru — which also does business as Female Health Company — completed the first stage of a bioequivalence (BE) clinical trial to support the filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) late this year or in early 2018. The BE study aims to show that DRS is similar in all its properties to Flomax. NDA approval is expected for the second half of 2018.

“Our results from Stage 1 of the BE trial demonstrated that Tamsulosin DRS may have an improved safety profile,” Veru President and CEO Mitchell Steiner, MD, said in a news release. “Unlike Flomax, Tamsulosin DRS is a slow-release powder that does not have to be administered after a meal and may be taken on an empty stomach. These benefits are especially important in the long-term care setting for men who have difficulty swallowing capsules or tablets and could also improve patient compliance.”

In Stage 2 of the BE clinical trial, researchers will compare the delivery of Tamsulosin DRS to Flomax in a large group of men with BPH. The medication is an extended-release powder formulation of the active ingredient in Flomax, a common oral treatment for BPH. Tamsulosin belongs to class of drugs alpha blockers, and works by relaxing bladder neck muscles and muscle fibers in the prostate itself, making it easier to urinate.

Tablets or capsules are problematic for 15 percent of men over the age of 60 with difficulties swallowing, and the up to 60 percent of men in long-term care facilities who have difficulty swallowing because of other medical conditions. Tamsulosin DRS is being developed for these men with BPH who have difficulty swallowing tablets or capsules.

“Today’s announcement further validates our product diversification strategy and recently completed merger transaction,” Steiner said. “Tamsulosin DRS should allow us to participate in the multibillion-dollar benign prostatic hyperplasia market and is just one of multiple drug candidates in our pharmaceutical pipeline that not only addresses large patient populations but also utilizes a potentially lower cost, lower risk and expedited approval pathway. We are making excellent progress with our entire drug portfolio and believe this is an important step in delivering significant value to our shareholders.”

NeoTract’s Minimally Invasive UroLift® System for Enlarged Prostate Now Shown to be Durable Through Five Years: Results from Pivotal L.I.F.T. Randomized Study Presented

PLEASANTON, Calif. and LONDON – March 27, 2017 – NeoTract, Inc., a medical device company focused on addressing unmet needs in the field of urology, today announced five-year follow-up data from the pivotal, randomized L.I.F.T. IDE study, which evaluated the safety and effectiveness of the company’s novel UroLift® System in patients with symptomatic benign prostatic hyperplasia (BPH).

Claus Roehrborn, M.D., professor and chair of the Department of Urology UT Southwestern Medical Center in Dallas and co-principal investigator for the L.I.F.T. clinical program, presented the results at the 18th annual European Urological Association meeting in London.

“The UroLift System is truly a new standard for the treatment of BPH. This conclusion of the landmark L.I.F.T. randomized clinical trial offers high quality clinical data that demonstrate the durable benefits this unique treatment option can offer,” said Dr. Roehrborn. “The UroLift System treatment delivers a truly minimally invasive patient experience: it can be performed efficiently and effectively under local anesthesia, typically without the need for a postoperative urinary catheter. Symptom relief is achieved rapidly, within two weeks, and at one month is very similar to what can be expected at five years.  Serious side effects of traditional surgery are avoided, and the UroLift System treatment is the only procedure shown to not cause sustained sexual issues.”

“I believe that the UroLift System should be considered an early treatment option for men with BPH, given the safety and benefits of the procedure and the large number of patients for whom pharmaceutical therapy is either insufficient or intolerable due to side effects, cost or inconvenience.”

Results of the five-year L.I.F.T. study demonstrate that UroLift System treatment provides:

  • A highly tolerable, minimally invasive procedural experience;
  • Rapid reduction of symptoms after the procedure while preserving sexual function;
  • Sustained effect, with IPSS (International Prostate Symptom Score) and Qmax (peak urinary flow rate) remaining 36% and 44% improved from baseline, respectively;
  • Quality of life (QoL) score improvement of 50% over five years;
  • A durable treatment with a low retreatment rate of 2-3% per year.

“This excellent long-term data reinforces our enthusiasm about the UroLift System treatment becoming the standard of care first-line treatment for men unhappy with BPH medications,” said Dave Amerson, president and CEO, NeoTract, Inc. “Adoption of the UroLift System continues to grow rapidly. We are excited to partner with urologists to help men return to normal urinary function and preserve sexual vitality with this safe and effective treatment option – the only BPH procedure that does not require cutting, heating or removal of the prostate tissue.”

Additional data from the L.I.F.T. clinical trial will be presented at the 2017 American Urological Association (AUA) conference taking place May 12-16 in Boston.

More than 37 million men in the United States are affected by BPH, which occurs with advancing age when the prostate gland that surrounds the male urethra becomes enlarged and begins to obstruct the urinary system. Symptoms of BPH often include sleepless nights and urinary problems, and can cause loss of productivity, depression and decreased quality of life.

Medication is often the first-line therapy for enlarged prostate, but relief can be inadequate and temporary. Side effects of medication treatment can include sexual dysfunction, dizziness and headaches, prompting many patients to quit using the drugs. For these patients, the classic alternative is surgery that cuts, heats or removes prostate tissue to open the blocked urethra.

About the UroLift System

The FDA-cleared UroLift System is a novel, minimally invasive technology for treating lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). The UroLift permanent implants, delivered during a minimally invasive transurethral outpatient procedure, relieve prostate obstruction and open the urethra directly without cutting, heating, or removing prostate tissue. Clinical data from a pivotal 206-patient randomized controlled study showed that patients with enlarged prostate receiving UroLift implants reported rapid and durable symptomatic and urinary flow rate improvement without compromising sexual function. Patients also experienced a significant improvement in quality of life. Most common adverse events reported include hematuria, dysuria, micturition urgency, pelvic pain, and urge incontinence. Most symptoms were mild to moderate in severity and resolved within two to four weeks after the procedure. The UroLift System is available in the U.S., Europe, Australia and Canada. Learn more at www.UroLift.com.

About NeoTract Inc.

NeoTract, Inc. is dedicated to developing innovative, minimally invasive and clinically effective devices that address unmet needs in the field of urology. The company’s initial focus is on improving the standard of care for patients with BPH using the UroLift System, a minimally invasive permanent implant system that treats symptoms while preserving normal sexual function. Learn more at www.NeoTract.com.

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Granger Urologist designated UroLift Center of Excellence

gange-3110

Dr. Steven Gange, of Summit Urology – Holladay, has recently had his practice designated the first-ever UroLift® Center of Excellence in the world. To appreciate the importance of this honor, it is necessary to understand the ground-breaking importance of the the UroLift System procedure.

If you are a man over the age of 50, chances are you have begun to notice changes in urination related to Benign Prostatic Hyperplasia (BPH), commonly referred to as an enlarged prostate. Although the prostate is principally a sexual organ (producing seminal fluid), it also encircles the tube through which men urinate (the urethra).

As men age the prostate both enlarges and tightens, ultimately restricting the flow of urine exiting the bladder, thereby creating numerous annoying voiding symptoms (like slow flow, urgency, dribbling, and nighttime trips to the bathroom). This condition affects most men: at least one-third of men will undergo some form of treatment for BPH in their lifetime.

In the past, BPH was most commonly treated with a surgery called TURP (transurethral resection of the prostate), sometimes referred to by men as a “roto-rooter.” Developed in the 1930’s, (with minor modifications since then) this procedure involves full anesthesia, a temporary catheter tube to help control bleeding, possible hospital stay, significant recovery time, and some potentially bothersome sexual side effects – 70% percent of men lose the ability to ejaculate, and 10% develop erectile dysfunction. With no good alternatives, TURP was the #1 most frequently performed surgery in the US throughout the 1960-70s. In the 1980-90s, BPH medications were developed, and TURP numbers began to decline; nevertheless medications are much less effective, and carry their own side-effect risks, so men continue to need procedural intervention for BPH. Laser-TURP procedures cause less bleeding and have gained in popularity, though have in no way eliminated side effects of TURP. After the abject failure of balloon dilation and stenting the prostate in the late 1990s, several minimally-invasive heat-based procedures were developed in the early 2000’s designed to be conducted in an office setting with less than full anesthesia; these are now waning in popularity because of problems with patient tolerability and a lack of durable effect.

Finally, a BPH procedure is available that is truly minimally invasive, without cutting or heating, very tolerable in an office setting under local anesthesia, without any sexual side effects and with much greater durability than any in-office procedure that came before it, and it is called UroLift (NeoTract, Pleasanton, CA). And Granger’s own Summit Urology Group’s Dr. Steven Gange has been instrumental in its development.

Invented in 2004 by a pair of Ph.D. biomedical engineers, the UroLift procedure is elegant in its simplicity. Rather than superheating or cutting tissue or otherwise changing the natural architecture of the prostate, the UroLift implant lifts (or more accurately pushes) the obstructing prostate away from the urethra, opening the narrowing and facilitating a return to normal urination. The procedure takes advantage of the natural urethral access and leaves no scars. 4-6 implants are applied in this 10-minute office procedure, and no catheter is typically required. Clinical trials for UroLift began in Australia in 2005 and later in Europe, in both locations performed exclusively in the operating room under full anesthesia. As news of the early successes reached the US, Dr. Steven Gange and his urologist partner Dr. Stephen Richardson (both involved in conducting clinical trials with Jean Brown Research) enthusiastically worked to become a part of the US FDA trial. The randomized LIFT trial as it was known took UroLift implantation a step further: these UroLift procedures would be conducted under local anesthesia. Jean Brown was selected as a treatment site for the LIFT trial, and on 3/18/2011 Dr. Gange (as Principal Investigator) performed not only the first UroLift in North America but the first UroLift in the world under local anesthesia. With Dr. Richardson as sub-Investigator, the two enrolled more men in the trial than anyone else in the US and Canada, and by so doing helped to reinforce the effectiveness seen in the International trials, but also demonstrating the unique level of tolerability of UroLift when performed under local anesthesia. Drs. Gange and Richardson have gone on to conduct two additional UroLift trials, and have been recognized for their efforts with co-authorship of many of the pivotal UroLift papers in the urological literature. Dr. Gange has been asked to present the UroLift research findings at several national urology meetings.

Upon successful completion of the LIFT trial, UroLift received FDA clearance in 2013. About a year later, Dr. Richardson, who for 20 years had himself been suffering from the symptoms of BPH but was unwilling to subject himself to the side effects of medications or the rigors of the available procedure options, asked Dr. Gange to perform his UroLift. His experience with the procedure was exactly as he expected – the six-minute procedure done in-office and under the same local anesthesia he had witnessed in his clinical trial subjects, caused only mild discomfort. No catheter was required, and he worked ten hours the next day without any issues whatsoever. His life has effectively been transformed and for the first time in two decades he now sleeps through the night. As a researcher, highly experienced clinical urologist, and now himself a UroLift patient, he has become a vocal advocate, and he now speaks regularly to BPH patients and patient groups across the country.

Spring boarding from the clinical trials experience Dr. Gange has further refined his anesthetic protocol to maximize tolerability while minimizing risks to patient safety. He has treated more men with in-office UroLift under local anesthesia than anyone in the world, including other physicians, corporate leaders, professional athletes, and men from across the US and even from several foreign countries. As his Summit Urology Group Highland Office team has gained expertise, NeoTract (the manufacturer of UroLift) has defined theirs as a Premier Patient Experience, and the company regularly sends urologists and their teams to Salt Lake City to observe cases. Further, as a consultant and inaugural Faculty Member for NeoTract, Dr. Gange has traveled extensively across North America teaching and proctoring urologists who are learning UroLift. As a result of his large number of procedures with consistently high-quality patient outcomes and his devotion to teaching and training others, Dr. Gange was awarded the first-ever UroLift Center of Excellence designee on November 1, 2016.

Approximately 1,000 US urologists are now trained to perform UroLift, including most of Dr. Gange’s Summit Urology partners. Currently, Summit Urology is the only place in the Salt Lake Valley that regularly performs this procedure. If you are bothered by BPH or the side-effects of medications used for it, look to Summit Urology Group for truly expert and state-of-the-art BPH care.

NHS England announces first medtech devices and apps to join fast track payment scheme for innovation

Medtech devices and apps will for the first time be included under NHS national payment rules helping to accelerate uptake, NHS England Chief Executive Simon Stevens has announced today.  The commitment to create a new Innovation and Technology Tariff was announced by Mr Stevens in June.

Now following clinical review, the first six innovations have today been selected as part of a new Innovation and Technology Tariff, benefiting women giving birth, patients with chronic lung problems, men having urological surgery, and acutely ill inpatients. NHS England is also, in parallel, backing new mobile technology solutions for diagnosing heart problems.

The new Innovation and Technology tariff will help cut the hassle experienced by clinicians and innovators in getting uptake and spread across the NHS. It will remove the need for multiple local price negotiations, and instead guarantee automatic reimbursement when an approved innovation is used, while at the same time allowing NHS England to negotiate national ‘bulk buy’ price discounts on behalf of hospitals, GPs and patients.

NHS England Chief Executive Simon Stevens said: “The NHS has a proud track record of world firsts in medical innovation but getting wide uptake has often been far too slow. Our new payment system brings clarity on fast track funding to get groundbreaking new treatments and technologies to NHS patients. Many of them not only improve care but will save the NHS money too.”

The innovation categories are:

Guided mediolateral episiotomy scissors to minimise the risk of obstetric injury – Approximately 15% of births in England require the woman to have an episiotomy. Of these, around 25% experiences a complication called Obstetric Anal Sphincter Injury, which causes anal incontinence and which may require reconstructive surgery. Using acute 60 degree angle episiotomy scissors during childbirth reduces the risk of this life changing complication. Preventing these injuries dramatically increases the quality of lives of new mothers who have undergone this procedure and halving litigation costs alone could save the NHS in the region £23.5million.

Arterial connecting systems to reduce bacterial contamination and the accidental administration of medication – Although rare, accidental injection of intravenous medication into an arterial line can lead to catastrophic injuries which sometimes require major amputations. Innovations that ensure this does not happen will increase patient safety in NHS hospitals.

Pneumonia prevention systems which are designed to stop ventilator-associated pneumonia – 100,000 patients are admitted for ventilation in the UK critical care units each year and 10-20% will go on to develop ventilated associated pneumonia (VAP). Between 3,000 and 6,000 people die from this type of pneumoniaevery year and prevention would save many lives. Treating VAP costs the NHS between £10,000 – £20,000 per patient and conservative estimates for prevention are savings to the NHS of over £100 million.

Web based applications for the self-management of chronic obstructive pulmonary disease – Digital applications for the self-management of COPD improve the quality of life for patients living with COPD. They give patients the ability to manage their condition by more effective use of their inhalers, and support for pulmonary rehabilitation without the need for face to face sessions. The savings based on reduction in the need for face to face pulmonary rehabilitation sessions are on average over £140,000 per year per CCG.

Frozen microbiota transplantation for recurrent Clostridium difficile infection rates – Faecal microbiota transplantation is a treatment for clostridium difficile infection. It is an effective alternative to antibiotic treatment for CDI at a comparable cost. High cure rates (90%) and reduced use of antibiotics equal a win-win for patients and the NHS.

Prostatic urethral lift systems to treat lower urinary tract symptoms of benign prostatic hyperplasia as a day case – An alternative surgical procedure for Benign prostatic hyperplasia (BPH), a common and chronic condition where the enlarged prostate can make it difficult for a man to pass urine, leading to urinary tract infections, urinary retention, and in some cases renal failure. This is an alternative to existing surgical treatments – TURP (transurethral resection of the prostate) or laser. These existing treatments involve cutting away or removing existing tissue, require an average hospital stay of 3 days and often catheterisation for many days post-surgery. This procedure uses adjustable, permanent implants to pull excess prostatic tissue away so that it does not narrow or block the urethra. Following the procedure, patients return home after a few hours, typically without catheter, and follow-up is normally by telephone. Patients have significantly fewer side effects (notably 0% risk of permanent sexual dysfunction) and post-operative complications, such as infection and bleeding, compared with existing alternatives. The procedure is increasingly carried out under a local anaesthetic.

Separately from the tariff, there will also be central funding for CCGs to purchase mobile ECG devices, which patients can use to identify and measure arterial fibrillation through mobile ECG technology. Early detection of arterial fibrillation in patients helps to prevent stroke, a serious and life threatening medical condition which can lead to long periods of rehabilitation and decreased independence and enjoyment of life for the patient and huge costs to the NHS.

Peter Ellingworth, Chief Executive of Association of British Healthcare Industries said: “This welcome new approach from NHS England will help ensure a robust, accessible and effective scheme that provides timely patient access to a wide range of medical technologies. We look forward to working with NHS England to implement these changes – and helping to develop an expanded scheme for 2018/19”

NHS England will directly fund the costs of six of the selected innovations in 2017/18 and will evaluate the impact of the Innovation and Technology Tariff in improving patient outcomes and increased efficiency across the NHS. It will expand the number of innovations covered by the tariff for future years, through a wider scheme that has been designed with industry, the NHS and the Academic Health Science Networks.

Dr Liz Mear, Chair of the AHSN Network, said: “AHSNs and their partners provide a key role in getting new treatment innovations adopted into the NHS for the benefit of patients and the population. As a national network we have worked with NHS England to support the introduction of the Innovation and Technology tariff and will support NHS organisations wanting to embrace innovation to help them get the latest medtech devices and services to their patients as quickly as possible.”

Notes to editors:

  • The new scheme goes live from April 1st 2017.
  • For 2017/18 applications for inclusion in the ITT were received via the National Innovation Accelerator (NIA) programme submission process. Innovators could apply to be considered for the NIA programme, the ITT or both. For 2018/19, the scheme will be widened beyond the NIA programme
  • 119 applications were received for innovative products or services to be considered for the ITT. The innovation had to be:
    • A mature innovation with a validated evidence base, already in use and ready for scaling
    • An innovation that delivers significantly increased quality and improved efficiency
  • Following the assessment process, involving NHS England, NICE, and UCL Partners Academic Health Science Network, the six innovation groups are to be included in the national ITT, subject to final consultation and commercial negotiation.
  • Products and innovations that fit with these groups can be used by providers and examples of these themes can be found in Part B of the National Tariff Consultation Document where it is also indicated for each innovation how it should be reimbursed, for example as an exclusion or as part of tariff, and either a mandatory or non-mandatory price. The introduction of any innovation from this list should be agreed between the provider and commissioner prior to implementation.
  • For prostate urethral lift systems, CCGs will fund it through a new tariff which is a cost saving compared to the existing surgical tariff.
  • This new innovation diffusion funding mechanism is consistent with policy direction recommended in the Department of Health’s recently published Accelerated Access
     

 

Read the original press release

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I have seen Dr. Gange for a number of years and developed the typical symptoms associated with an enlarged prostate. During my annual urologist visit, Dr. Gange laid out my options. After doing some personal research, I elected to have the Urolift procedure performed by Dr. Gange on an outpatient basis.

The procedure was uncomfortable but not particularly painful compared to other surgeries I have had. Recovery was relatively quick and I was back at work after two days of rest.

I did experience some significant discomfort associated with urination but was counseled that I was not drinking enough water. Once I increased my consumption of water, most of the discomfort went away and I was back to normal after about two weeks.

In the wake of the surgery, the urgency to urinate has gone away. The interval between trips to the bathroom has lengthened significantly such that I usually get up to urinate only once each night and sometimes not at all.

Having talked with others who have had more drastic prostate surgery, I feel that the Urolift procedure was much less stressful and the results were as hoped for.