Introducing PrecisionPoint™

Introducing the PrecisionPoint™ Transperineal Access System

Introducing the PrecisionPoint™

Transperineal

Access System

The PrecisionPoint™ Transperineal Access System revolutionizes the methodology for obtaining prostate biopsies. This medical system takes full advantage of the transperineal path to more thoroughly sample all regions of the prostate including those difficult to access with the transrectal approach. Since the technique is free hand, the practitioner can easily target the desired locations with certainty and through a single puncture of the skin.

In addition, the PrecisionPoint™ minimizes the potential for infection, since passage of the biopsy needle avoids the rectal wall contaminants entirely.

For the patient, this means no bowel prep or need to pre-medicate with antibiotics. The PrecisionPoint™ enables the practitioner to perform the biopsy under local anesthesia in a short duration procedure.

The PrecisionPoint™- Reinventing Prostate Biopsy

In The Media: PrecisionPoint™ and Related Topics

by Michael A. Sawyers (Cumberland Times-News, Mar 1, 2017)

CUMBERLAND — As the use of a prostate-biopsy device invented by a Cumberland physician expands around the world, it is likely there will be fewer and fewer post-procedure infections.

“We can humbly say that since going to this technique we have had zero infections at our center,” said Dr. Matthew Allaway of Urology Associates on Williams Road.

Each year, there are 1.2 million prostate gland biopsies in the United States. There are are about 500 annually at Urology Associates.

Instead of guiding the sampling needle through the rectal wall, where fecal coliform bacteria can become attached and be transferred, Allaway’s device allows for an alternate or transperineal route to the prostate gland, not simply reducing subsequent infections, but avoiding them.

With this method, the pathway to the prostate is in front of the rectal wall, not through it.

“Some locations (using the transrectal approach) were seeing infection rates as high as 6 percent following biopsy,” Allaway said. “And these are life-threatening infections that almost always require hospitalization of two or three days. The usual case is that 36 hours after the biopsy there is a fever with chills and shakes.”

A year ago, when the Cumberland Times-News published a story about the device, clearance was being awaited from the Food and Drug Administration.

That clearance came a few months later.

“Following that article, we got calls from men in New York and Tennessee who wanted to come here for their biopsies,” Allaway said.

And, since FDA provided clearance, 5,000 devices — officially called Precision Point Transperineal Access System — have been manufactured and some are in use in various parts of the country.

Twenty-five physicians have come to Cumberland to be trained to use the device. They work at hospitals such as Johns Hopkins, Cleveland Clinic, MD Anderson Cancer Center in Houston and Rush University in Chicago.

Training typically lasts two days.

Allaway sometimes travels to other hospitals to provide training.

Dr. Mohammad E. Allaf, of the Brady Urological Institute at Johns Hopkins Hospital, sent Allaway a Tweet describing how well the device had worked and saying it would become the new standard of care for prostate biopsies.  

Dr. Mohammad E. Allaf

Dr. Mohammad E. Allaf, a urologist at Johns Hopkins Hospital, told Dr. Matthew Allaway he believes the local physician’s prostate biopsy device will become the standard of care. Photo from Johns Hopkins Hospital website

The world headquarters of Perineologic will open soon at 183 North Centre St. in Cumberland.

Allaway, president of the company, along with his wife, Kelli Allaway, chief financial officer, and John M. Hart, chief operating officer, have been frequent fliers to destinations where they describe the device to health care professionals.

“Our next trip is to New Jersey, but we have recently been to Ruby and Mon General hospitals in Morgantown and the Charleston Area Medical Center,” Hart said. “There are 100 meetings a year that we should be sending someone to for marketing and sales.”

The group’s trip planner includes visits to California and Kaiser Permanente, the biggest health system in the country, as well as to London and the 14,000-member European Urology Association and to Boston and the American Urology Association with 20,000 members.

A visit to Wales is in the rearview mirror.

Clearance to market the device internationally is anticipated in April, Hart said.

The device is being manufactured at Bridgemedica near Boston.

“We found out that FDA clears only 5 percent of the medical devices it evaluates,” Matthew Allaway said. “And Bridgemedica said the FDA clearance for our device was the fastest they had seen.”

Hart said potential markets include the United Kingdom, Ireland, Italy and Australia.

Manufacturing is the only aspect of the company that won’t take place in Cumberland.

“Distributing, marketing, sales and design will all take place here,” said Kelli Allaway. The group anticipates employing 10 to 15 individuals.

Not only does the device provide a safer route to the prostate, but results in a better cancer diagnosis, according to Matthew Allaway.

“We can sample the entire prostate, which couldn’t be done using the old method,” he said.

A (WARNING) graphic demonstration video is available on YouTube. As of mid-February it had been viewed more than 1.3 million times.

Hart said the company reached out first to the medical industry’s thought leaders, anticipating that the word would be spread to practitioners.

“But we want a public awareness, as well,” Matthew Allaway said. “We want a man who needs a biopsy to know that this new, healthier way exists.”

bloomberg_article

Doing a tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder. The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream. Source: BSIP/UIG Via Getty Images

Doctors are changing their approach to prostate biopsies as evidence mounts that the danger of complications from the procedure may outweigh its usefulness identifying some cancers.

An increasing incidence of potentially lethal, difficult-to-treat bloodstream infections tied to prostate biopsies has become so serious that urologists are reassessing when, how and even if they do the procedure.

To reduce the risks, doctors are turning to a longer, costlier — but ultimately safer — approach to detect tumors that entails avoiding the bacteria-laden rectum. And though global evidence is scant, in Australia data shows doctors are scaling back their reliance on biopsies altogether. In the U.S., doctors say anecdotal evidence also suggests prostate biopsies are probably decreasing.

“People have started to sit up and say, ‘hey, maybe we need to rethink what we’re doing,’” said Nathan Lawrentschuk, an associate professor of surgery at the University of Melbourne and a urologist at Melbourne’s Austin Hospital.

The response reflects the growing threat of bowel-dwelling bacteria that even the world’s most powerful antibiotics are unable to snuff out. It’s also adding to the debate about the importance of diagnosing prostate cancer. While it’s one of the most common malignancies of men, tumors are slow-growing in most cases and treatment often causes impotence and incontinence.

Sepsis Risk

Doing a tissue biopsy of the prostate to detect cancer typically entails sending an ultrasound-guided needle about a dozen times through the rectum to collect specimens from the walnut-sized gland that sits under the bladder.

The test carries an infection risk because the needle can take bacteria from the bowel into the prostate, bladder and bloodstream. The 15-minute procedure, usually performed in a doctor’s office under local anesthetic or light sedation, can be dangerous if the bacteria are resistant to antibiotics given at the time of the biopsy. Bacteria that escape into the bloodstream can cause sepsis, a condition that can lead to multiorgan failure and death.

“Greater recognition of the infectious risks of biopsy has led us to be much more careful about who we select for prostate biopsy,” said Stacy Loeb, assistant professor of urology and population health at New York University. “All patients should be evaluated for risk factors for resistant bacteria and infection, and should be counseled about the risks and benefits of proceeding to biopsy.”

PSA Screening

The most common reason to perform a biopsy is an abnormal result from PSA screening, a blood test for a protein produced by prostate cells known as prostate-specific antigen. The test is controversial because, while it may signal the likelihood of prostate cancer, it can’t definitely detect it. Nor can it distinguish among benign tumors, slow growing cancers and deadly malignant ones. That’s led many doctors to question the wisdom of using PSA screening results to make treatment decisions.

“The risk of sepsis has made all of us think a little bit longer before recommending a biopsy,” said David Bell, head of urology at Dalhousie University in Halifax, Nova Scotia, adding that he tends to avoid the transrectal approach in repeat biopsies.

Bell says he’s now more tolerant of a slightly abnormal PSA and looks for other supporting reasons to indicate a biopsy is necessary, such as when PSA increases rapidly over time or is especially high. Other factors to consider include whether a palpable nodule develops, or if the patient has African ancestry or has a family history of early-onset prostate cancer or death from prostate cancer.

Fewer Biopsies

In Australia, the number of prostate biopsies performed per capita has declined the past three years from a peak in 2009, government records show.

More than 800,000 prostate biopsies are done in the U.S. each year. There isn’t good quality data in the U.S. to track frequency trends, New York University’s Loeb said. Anecdotal evidence, however, suggests the “overall number of biopsies is decreasing,” Otis Brawley, chief medical officer of the American Cancer Society, said in an e-mail.

The declining biopsy rate in Australia reflects concern about infection, as well as the availability of alternative tools, such as magnetic resonance imaging (MRI), to identify patients most likely to benefit from it, said Mark Frydenberg, head of urology at Monash Medical Centre in Melbourne.

Minimize Risk

“The best way to minimize the risk is by not having a biopsy at all,” Frydenberg said. “If you do need a biopsy, then the decision rests between going down the transperinealroute or transrectal route.”

The perineum, the skin between the bottom of the scrotum and the anus, is a safer entry point because it can be cleaned with antiseptic, unlike the rectum, said Lindsay Grayson, Austin Hospital’s head of infectious diseases.

The lower risk of infections means urologists can take more core samples of the prostate, especially of the part of the gland that’s difficult to reach from the rectum, Frydenberg said.

On the downside, the procedure takes at least twice as long to perform, requires heavier patient sedation, six people in an operating theater, and equipment costing about $100,000, he said.

No studies have examined the infection risk from prostate biopsies globally. Instead doctors are trying to gauge the scope of the problem from studies emerging from North America, Europe and Asia.

The chance of being hospitalized within a month of a biopsy increased fourfold in Ontario in less than a decade, reaching 4.1 percent in 2005 from 1 percent in 1996, Robert Nam and colleagues at Toronto’s Odette Cancer Centre, wrote in a study published in the Journal of Urology in 2010. Almost three-quarters of the hospitalizations were infection-related.

‘Barbaric’ Procedure

“Given the recent spike in infection complications after prostate biopsy, the ideal method to diagnose prostate cancer must be pondered,” Matthew Gettman, professor of urology at the Mayo Graduate School of Medicine in Rochester, Minnesota, wrote in an editorial in the journal European Urology last May. “Despite local anesthetics, the whole procedure is barbaric, and it is surprising that the issue of infection has not come to light years ago.”

Infectious complications have typically occurred in 3 percent to 5 percent of prostate biopsy patients at Austin Hospital, Lawrentschuk said. Doctors have sought to curb rising rates of infection by using increasingly powerful antibiotics. The problem is resistance is building to even the broadest-spectrum drugs, forcing doctors to look for other ways to minimize risks. “That’s huge,” said Brawley, of the American Cancer Society.

Anecdotal Reports

“You do hear these anecdotal reports of deaths, but I have only heard of one in Melbourne in the last three or four years,” Lawrentschuk said. “In terms of sepsis and admissions to the ICU, they seem to be more common. Even if the sepsis rates aren’t higher, the stakes are higher because you are getting organisms that are trickier to treat.”

The Moffitt Cancer Center in Tampa, Florida, has revised its biopsy protocol over the past two years with the help of infectious disease physicians to minimize complications, said Wade Sexton, a urologist and director of the hospital’s urologic oncology fellowship program.

Rectal Swabs

In addition to being as selective as possible with initial biopsies and repeat procedures, the center now performs rectal swabs on every patient undergoing a prostate biopsy within one month of the procedure to make better informed choices about what antibiotics to use based on any resistant bugs found, Sexton said.

“This is a step we’re taking to try to minimize the risks as best as possible until additional evidence becomes available,” he said. “Whether this approach is cost-effective remains to be determined.”

Patients who have traveled to South Asia, Southeast Asia and other regions where there is a high incidence of infections caused by multidrug-resistant bacteria are told to wait at least six months from their return to have a prostate biopsy, Lawrentschuk said. Where there is a more urgent need, travelers are given a different antibiotic — one from the last-resort class known as carbapenems.

Doctors are also testing fosfomycin, a broad-spectrum antibiotic discovered in Spain in 1969, for its ability to penetrate the prostate. Preliminary results of research carried out at Austin Hospital suggest it’s promising, Lawrentschuk said.

Read this article on Bloomberg.com

Alex Carignan a,*, Jean-Franc ̧ ois Roussy a, Ve ́ronique Lapointe a, Louis Valiquette a, Robert Sabbagh b, Jacques Pe ́pin a

a Department of Microbiology and Infectious Diseases, Universite ́ de Sherbrooke, Quebec, Canada; b Department of Surgery, Universite ́ de Sherbrooke, Quebec, Canada

Abstract

Background: An increasing risk of infectious complications following transrectal ultrasound–guided prostate needle biopsy (PNB) has been observed recently in some centers.
Objective: To delineate the risk factors associated with post-PNB bacteremia and/or urinary tract infection (UTI) and determine why this risk has risen over time.

Design, setting, and participants: A case–control study in a Canadian tertiary-care center. Cases were all patients who developed bacteremia and/or UTIs after PNB between 2002 and 2011; controls were randomly selected among patients who under- went a PNB without such complications.

Outcome measurements and statistical analysis: Crude and adjusted odds ratios and their 95% confidence intervals were calculated using logistic regression.
Results and limitations: A total of 5798 PNBs were performed during the study period, following which there were 48 cases of urinary sepsis (42% with bacteremia). The incidence increased from 0.52 infections per 100 biopsies in 2002–2009 to 2.15 infections per 100 biopsies in 2010–2011 ( p < 0.001). Escherichia coli was the predominant pathogen (75% of cases). Among 42 patients whose post-PNB infection was caused by aerobic or facultative Gram-negative rods, 22 patients (52%) were infected by pathogens resistant to ciprofloxacin. Independent risk factors for post- PNB infection were diabetes, hospitalization during the preceding month, chronic obstructive pulmonary disease, and performance of the biopsy in 2010–2011. In 2010–2011, the minimal inhibitory concentrations for ciprofloxacin increased com- pared with 2002–2009 ( p < 0.03). The major limitation of the study was its retro- spective hospital-based nature, which hampered data collection on outpatient antibiotic prescriptions.

Conclusions: In the past 2 yr, ciprofloxacin resistance contributed to the increasing incidence of post-PNB infections in our center. Novel antibacterial prophylaxis approaches need to be evaluated.
Crown Copyright # 2012 Published by Elsevier B.V. on behalf of European Association of

Urology. All rights reserved.

* Corresponding author. Department of Microbiology and Infectious Diseases, Universite ́ de Sherbrooke, 3001, 12th Ave. North, Sherbrooke, Quebec, J1H 5N4, Canada.
E-mail address: Alex.Carignan@USherbrooke.ca (A. Carignan).

To read full article click here.

John Michael DiBianco, Jeffrey K. Mullins, Matthew Allaway

Abstract

Introduction

There is growing interest in the use of transperineal prostate biopsy due to the advantages of decreased infection risk and improved cancer detection rates. However, brachytherapy stepper units and templates may increase costs and operative time for the practicing urologist. We present the safety, feasibility and early outcomes of a single urologist’s experience with ultrasound guided freehand transperineal prostate biopsy as an alternative to transrectal ultrasound guided biopsy.

Methods

A retrospective review of all prospectively performed ultrasound guided freehand transperineal prostate biopsies between January 1, 2012 and April 30, 2014 was performed. Primary outcome measurements were safety and feasibility.

Results

A total of 274 ultrasound guided freehand transperineal prostate biopsies were performed in 244 patients. Operative and total operating room use times were 7.9 and 17.5 minutes, respectively, with an average of 14.4 cores obtained during each procedure. The overall cancer detection rates for all procedures, those in biopsy naïve patients and those performed for active surveillance were 62.8%, 56.4% and 89%, respectively. New diagnoses of prostate cancer occurred in 41.2% of patients with 10% positive after a previous negative transrectal ultrasound guided biopsy. Complications (Clavien grade I or greater) including systemic infection, urinary retention and hematuria or pain requiring physician or hospital intervention did not occur.

Conclusions

The use of ultrasound guided freehand transperineal prostate biopsy for the suspicion or surveillance of prostate cancer is feasible and safe. The results were encouraging with respect to the primary outcome measurements. Ultrasound guided freehand transperineal prostate biopsy with the patient under local anesthesia is currently under investigation. Large, prospective, randomized, multiple operator studies to evaluate the comparative effectiveness of freehand transperineal prostate biopsy and transrectal ultrasound guided biopsy techniques are recommended.

 To read more at Urology Practice Journal, click here.

by Michael A. Sawyers (Cumberland Times-News, Mar 3, 2016)

CUMBERLAND — A Cumberland urologist is in great demand these days, traveling to places such as the Cleveland Clinic, University of Michigan and MD Anderson Cancer Center in Texas to explain a safer, more accurate prostate biopsy method he perfected and a new device to perform the procedure.

“I have been told by highly placed people that it could change the standard of care,” said Dr. Matthew Allaway, seated this week in his office at Urology Associates on Williams Road.

Instead of guiding the sampling needle through the rectal wall, where fecal coliform bacteria can become attached and be transferred, Allaway, in a few hundred patients, has used a transperineal route to the prostate gland, not simply reducing subsequent infections, but avoiding them.

With this method, the pathway to the prostate is in front of the rectal wall, not through it.

“Some locations (using the transrectal approach) were seeing infection rates as high as 6 percent following biopsy,” Allaway said. “And these are life-threatening infections that almost always require hospitalization of two or three days. The usual case is that 36 hours after the biopsy there is a fever with chills and shakes.”

In addition to being safer, the transperineal method is a more accurate detector of prostate cancer, according to Allaway.

Allaway has thus far used a free-hand approach to the transperineal method of prostate biopsy. He guides the ultrasound tool with one hand and the needle with the other. In May, that is likely to change.

“The free-hand method is tricky and can be intimidating (to physicians),” he said.

Allaway created a one-piece device that provides ultrasound imagery and needle penetration.

“We have the patent and are awaiting (Food and Drug Administration) approval that the device is safe to use,” Allaway said. “We expect a product launch in May.”

Allaway created a company to produce the devices. They will be manufactured in New Hampshire, but much of the other business related to the product will be Cumberland-based.

“We will train surgeons here to use the device,” Allaway said. “Sales, marketing and distribution will all take place here in Cumberland.”

Treating prostate cancer is vital, according to Allaway.

“We’ve never cured a person once the cancer has escaped the prostate, though we have been able to prolong lives,” he said.

Data from 2010-2012 show that 14 percent of men will be diagnosed with prostate cancer in their lifetimes.

Allaway’s next stop on his tour to explain how outcomes can be improved for those who have their prostates biopsied will be the United Kingdom.

Dr. Allaway discusses the PrecisionPoint system on the podcast Record.Talk.Listen. (Originally broadcast on June 5th, 2016.)
A men’s health discussion with Dr. Allaway on the podcast Record.Talk.Listen. (Originally broadcast on November 1st, 2015.)