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Dive Brief:

• Edwards Lifesciences is recalling a guide sheath used with its Pascal transcatheter mitral valve repair system sold in Europe because of possible damage to the device’s inner liner due to a manufacturing issue.
• While no adverse events or injuries to patients were reported from the problem, the sheath was recalled because an embolization could occur in a segment of the liner material if the device is used, according to an urgent field safety notice shared among international regulators. There was no information to suggest patients already implanted could be affected.
• Physicians were instructed not to use the guide sheaths and to return them to Edwards.

Dive Insight:

The catheter-based Pascal device is an important new product for Edwards, expected to help expand the market for mitral valve repair technology now dominated by Abbott’s MitraClip. The CE-marked device is just beginning to roll out in Europe, and enrollment is underway in U.S. clinical trials.

In the urgent field safety notice, Edwards stressed that the recall affected only the guide sheath and not the whole Pascal transcatheter valve repair system. Damage to the inner liner of the sheath occurred in 1 in 200 units, or about 0.5% of the units, according to the notice.

The Pascal system generated only $10 million in revenue for Edwards in the third quarter, slightly below the company’s initial expectations. On the earnings call last month, executives said the company was launching the device into the market slowly to ensure success with the procedure. A premium pricing approach also slowed adoption. The company tempered its full-year outlook for Pascal, saying it now expects sales to be below the $40 million previously projected.

Longer term, the outlook is much more ambitious. Edwards has estimated the market opportunity for mitral and tricuspid disease treatments combined could reach $1 billion by 2021 and about $3 billion by 2024.

The mitral repair device complements Edwards’ successful Sapien aortic valve replacement system in its structural heart portfolio. The company projects the transcatheter aortic valve replacement market could reach $7 billion by 2024.

The company is evaluating Pascal in U.S. pivotal trials in patients with primary mitral valve disease, associated with the structure of the valve, and for secondary mitral valve disease, which can develop in heart failure patients when the left chamber of the heart becomes enlarged, preventing the mitral leaflets from closing normally.

In September, Edwards received FDA approval to begin a pivotal trial of Pascal in patients with severe tricuspid valve regurgitation.

All lots of model Nos. 10000GS and 10000GSCE are subject to the recall.

Dive Brief:

• FDA cleared the first duodenoscope with a sterile, disposable elevator component Friday in an effort to cut down on the risk of infection from reprocessing the class of devices. The marketing authorization, granted to Pentax of America, follows GI Scientific’s clearance for an adjunctive device to shield the distal end of a duodenoscope in October and previous clearances for duodenoscopes with removable endcaps.
• Duodenoscopes, devices used in endoscopic retrograde cholangiopancreatography procedures to diagnose or treat bile duct, liver, gall bladder and pancreas issues, have been linked to persistent contamination issues related to inadequate reprocessing of the devices.
• In August, FDA issued a safety communication urging the development of new types of duodenoscopes with disposable parts due to the risk of infection from fixed endcap models.

Dive Insight:

Center for Devices and Radiological Health Director Jeff Shuren called the Pentax clearance “another major step toward lowering the risk of infection among patients,” calling duodenoscope safety a top priority for the agency.

“We encourage manufacturers of these devices to continue to pursue innovations that will help reduce risk to patients, and also encourage hospitals and other health care facilities where these procedures are performed to begin or continue transitioning to devices with disposable components that are easier to reprocess,” Shuren said in a statement.

The new Pentax Medical Video Duodenoscope ED34-i10T2 is notable because FDA identified the elevator component as a traditionally difficult part to properly clean. The part is used to access the bile and pancreatic ducts by helping to guide duodenoscope endoscopic instruments.

Between Oct. 15, 2018, and March 31, adverse event reports showing three deaths associated with duodenoscopes, 45 patient infections and 159 cases of device contamination were reported, according to FDA.

Risks of using the device include “potential for injuries, including, but not limited to, burns, electric shock, perforation, infection and bleeding,” according to FDA.

On Nov. 8, FDA convened an advisory committee to give recommendations on how to reduce the risk of duodenoscope infections between patients. The meeting follows scrutiny of duodenoscope safety by Senate health committee Ranking Member Patty Murray, D-Wash.

The panel noted complicated instructions for reprocessing of the devices and poor work conditions for low-paid employees contributed significantly to inadequate cleaning of duodenoscopes. It also agreed with FDA that standardized durability testing would help decrease the risk of infection.

Single-use duodenoscopes are currently being developed by Boston Scientific and Danish medical device firm Ambu.

SILVER SPRING, Md., Nov. 15, 2019 /PRNewswire/ — The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a single use, disposable, soft contact lens that is discarded at the end of each day, and is not intended to be worn overnight.

“Today’s approval is the first FDA-approved product to slow the progression of myopia in children, which ultimately could mean a reduced risk of developing other eye problems,” said Malvina Eydelman, M.D., director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices in the FDA’s Center for Devices and Radiological Health.

Myopia is the most frequent cause of correctable visual impairment worldwide. Myopia occurs when the eye grows too long from front to back (axial length). Instead of focusing images on the retina, images are focused at a point in front of the retina. As a result, people with myopia have good near vision, but poor distance vision that can be corrected with glasses or contact lenses.

Myopia is common in children and tends to increase as they get older. If a person develops severe myopia as a child, they may be susceptible to other eye problems such as early cataracts or a detached retina during adulthood. The MiSight soft contact lenses are meant to be worn daily to correct nearsightedness and slow the progression of myopia in children with healthy eyes. When placed on the eye, one part of the MiSight contact lens corrects the refractive error to improve distance vision in nearsighted eyes, similar to a standard corrective lens. In addition, concentric peripheral rings in the lens focus part of the light in front of the retina (the back of the eye). This is believed to reduce the stimulus causing the progression of myopia.

The approval of MiSight was based on data obtained from a prospective clinical trial at four clinical sites and real-world evidence. The safety and effectiveness of MiSight was studied in a three-year randomized, controlled clinical trial of 135 children ages 8 to 12 at the start of treatment who used MiSight or a conventional soft contact lens. The trial showed that for the full three-year period, the progression in myopia of those wearing MiSight lenses was less than those wearing conventional soft contact lenses. In addition, subjects who used MiSight had less change in the axial length of the eyeball at each annual checkup. Over the course of the trial, there were no serious ocular adverse events in either arm of the study.

Additionally, to estimate the rate of vision-threatening corneal infections (i.e., corneal ulcers) among children and adolescents who wear soft contact lenses daily, the FDA reviewed real world data from a retrospective analysis of medical records of 782 children ages 8 to 12 years old from seven community eye care clinics. The results showed a rate comparable to the rate of ulcer cases among adults who wear contact lenses daily.  

As part of the approval of MiSight, the sponsor is required to conduct a postmarket study of the contact lenses to further evaluate the safety and effectiveness of the product as indicated.

The FDA granted approval of MiSight to CooperVision Inc. The device was approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

For more information:

• FDA – Contact Lenses

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

A year after Bristol-Myers Squibb walked away from acquiring Promedior and its fibrotic treatment portfolio, Swiss pharma giant Roche has stepped in to acquire the company and its pipeline for up to $1.4 billion.

At the heart of the deal is Promedior’s lead product, PRM-151, which received Breakthrough Therapy Designation from the U.S. Food and Drug Administration in March for the treatment of idiopathic pulmonary fibrosis (IPF). Earlier this year, ahead of the designation, Promedior reached an agreement with the FDA for the design of a Phase III registrational study in idiopathic pulmonary fibrosis, with forced vital capacity as a primary endpoint. PRM-151 is a novel investigational anti-fibrotic immunomodulator, a recombinant form of human pentraxin-2 (PTX-2) protein.

For Roche, PRM-151, should it hit its developmental and regulatory milestones, will bolster the company’s existing IPF drug, Esbriet. The medication became part of the company’s pipeline in 2014, after Roche acquired Brisbane, Calif.-based InterMune, in an $8.3 billion deal. Esbriet was approved by the U.S. Food and Drug Administration two months after the acquisition was announced. Roche and its subsidiary Genentech have been waging a legal battle to prevent competitors from selling generic versions of Esbriet. The only other approved therapy for IPF is Boehringer-Ingelheim’s Ofev.

In addition to idiopathic pulmonary fibrosis, PRM-151 has also shown promising early clinical trial data in myelofibrosis (MF) and its anti-fibrotic mechanism has therapeutic potential in other fibrotic diseases, Promedior said in its announcement.

James Sabry, global head of Roche Pharma Partnering, said the big pharma company is excited about combining Promedior’s portfolio with our drug development capabilities to further advance PRM-151 in fibrotic diseases, including IPF and MF.

“With our proven track record in IPF with Esbriet, as well as in hematological cancers, we are well-positioned to leverage our clinical and commercial expertise to bring PRM-151 to patients as fast as possible,” Sabry said in a statement.

Under the terms of the agreement, Roche will make an upfront cash payment of $390 million, plus additional contingent payments of up to $1 billion based on the achievement of certain predetermined development, regulatory and commercial milestones.

It was only four years ago that BMS was set to acquire Promedior. In 2015, the companies struck a deal that was worth up to $1.25 billion, with $150 million in upfront cash put down by BMS. The big company walked away though and Roche stepped in for a deal.

Idiopathic pulmonary fibrosis is a fatal disease caused by progressive scarring of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly. The disease can advance quickly or slowly, but eventually, the lungs will harden and stop working altogether. There is no known cure for IPF. The median survival time from diagnosis is two to five years, and the five-year survival rate is approximately 20% to 40%.

In Phase II, PRM-151 demonstrated both prevention and reversal of fibrosis, Promedior said.  Results from that trial demonstrated that PRM-151 is the first molecule to show significant lung function improvements on top of current therapies in IPF, the company added.

“With over a decade of research, development and investment, Promedior has demonstrated the unique ability of its pentraxin-2 platform to deliver disease-modifying potential in fibrotic disorders. Due to Roche’s strong expertise in IPF, hematological cancer and other fibrotic disorders, we believe Roche is ideally positioned to bring the potential of our platform to patients and provide new treatment options within these areas of urgent unmet medical need,” Jason Lettmann, chief executive officer of Promedior said in a statement.

China’s BeiGene announced that the U.S. Food and Drug Administration (FDA) had given its Brukinsa (zanabrutinib) accelerated approval for mantle cell lymphoma (MCL) in adults who had received at least one prior therapy. It is the first BeiGene-discovered drug to be approved.

Reuters notes that the approval validates the company’s strategy of mostly using data from clinical trials held outside the U.S. The approval was based on two clinical trials with only about 10% to 15% of the participants were in the U.S., with about three quarters Asian and 21% Caucasian.

“The FDA has assessed our data and they believe that the response rates are applicable to all ethnic groups and is representative of a population that would be treated in the U.S.,” Jane Huang, BeiGene’s chief medical officer, told Reuters ahead of the decision. “We are now incorporating China patients into global clinical trials in a greater proportion, and this is a strategy for us to be able to get our drugs to people around the world as quickly as possible.”

MCL is a rare, aggressive type of non-Hodgkin lymphoma that mostly affects men over the age of 60. There are about 3,000 to 4,000 new diagnoses in the U.S. each year.

“We are working to improve outcomes for people with cancer worldwide and this approval brings us closer to realizing our mission of bringing the highest quality therapies to patients globally,” said John V. Oyler, chairman, co-founder and chief executive officer of BeiGene. “Today’s FDA approval of Brukinsa, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL. We hope this is the first of many approvals for Brukinsa as we continue to evaluate its potential in other hematologic cancers.”

Brukinsa is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK). It is being studied worldwide as a monotherapy and in combinations to treat B-cell malignancies. The China National Medical Products Administration (NMPA) is currently reviewing New Drug Applications (NDAs) for the drug for relapsed refractory (R/R) MCL and R/R chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

The drug will compete with Johnson & Johnson and AbbVie’s Imbruvica, AstraZeneca’s Calquence, and Celgene’s Revlimid.

On November 1, Thousand Oaks, California-based Amgen significantly expanded its presence in China by taking a 20.5% stake in BeiGene. Under the terms of a strategic collaboration deal, Amgen is paying about $2.7 billion in cash and nominating a BeiGene board member.

Under the deal, BeiGene will commercialize Xgeva, Kyprolis and Blincyto in China. The two companies will split profits and losses evenly. Two of the drugs will revert to Amgen, one after five years, the other after seven years. After that commercialization period ends, BeiGene will be able to retain one product and receive royalties on China sales for another five years on the product rights it returns to Amgen.

The two companies will also collaborate on 20 drugs from Amgen’s oncology pipeline in China and globally. BeiGene will invest up to $1.25 billion in research and development costs. Amgen will pay royalties to BeiGene on sales of any of these drugs outside of China except for AMG 510, which is being developed for solid tumors.

Amgen plans to continue to market its non-cancer drugs in China. Earlier this year, for example, it launched Repatha for cholesterol in China. It plans to launch several more outside of cancer in the country over the next few years, including Prolia for osteoporosis.

The U.S. Food and Drug Administration (FDA) approved Shionogi’s Fetroja as a treatment for adult patients with complicated urinary tract infections caused by a number of Gram-negative microorganisms.

The approval came only a few days after the U.S. Centers for Disease Control and Prevention issued a report that antibiotic-resistant infections have grown significantly in the United States over the past six years. The CDC said more than 2.8 million antibiotic-resistant infections annually occurred in the U.S., leading to the deaths of more than 35,000 people. Of those deaths, Clostridioides difficile (C. diff) infections resulted in nearly half, with 12,800 deaths.

John Farley, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said the growing threat antimicrobial-resistant infections is a key challenge for the regulatory agency. The approval of Fetroja “represents another step forward in the FDA’s overall efforts to ensure safe and effective antimicrobial drugs are available to patients for treating infections,” Farley said in a statement.

The approval of Fetroja marks the first antibiotic to function as siderophore, a molecule that transports iron into microorganisms. Once inside the bacteria, Fetroja is stable against all known classes of beta-lactamases. Fetroja addresses many of the resistance mechanisms that bacteria employ against antibiotics, the company said.

Fetroja was approved under Fast Track Designation and Priority Review and is expected to be commercially available in early 2020. Isao Teshirogi, president and chief executive officer of Japan-based Shionogi, said the approval of Fetroja will fill an important unmet medical need due to its “unique method” of penetrating the cell wall of Gram-negative bacteria. Those Gram-negative microorganisms specifically indicated for Fetroja’s use by the FDA include Escherichia coli, Klebsiella pneumonia, Proteus mirabilis, Pseudomonas aeruginosa and Enterobacter cloacae complex. Teshirogi also pointed to the drug’s ability to “overcome” many of the resistance mechanisms that bacteria employ against antibiotics.

“Today’s approval represents Shionogi’s ongoing commitment to develop medicines that help fight these life-threatening infections in patients for whom limited or no alternative treatment options exist,” Teshirogi said in a statement.

Approval of the drug is based on data from the pivotal APEKS-cUTI study that evaluated Fetroja (cefiderocol) against imipenem/cilastatin (IPM/CS) in patients with cUTI. Results from that study showed the response rates for the composite endpoint of microbiological eradication and clinical response at the test of cure were significantly higher in the Fetroja arm compared to the IPM/CS arm. In the study, 72.6% of Fetroja patients met the primary endpoint versus 54.6% in the IPM/CS arm at test of cure. The adjusted difference between the groups was 18.58%, the company added. Clinical response rates at the test of cure visit were similar between both Fetroja and IPM/CS. That data was strong enough for an advisory committee to vote 14-2 last month in favor of approval.

The approval for Fetroja does come with a black box warning. The label includes a warning regarding the higher all-cause mortality rate observed in Fetroja-treated patients compared to those treated with other antibiotics in a trial in critically ill patients with multidrug-resistant Gram-negative bacterial infections. The FDA said it has not been established what has caused the increase in mortality rate. The higher all-cause mortality rate was observed in patients treated for hospital-acquired/ventilator-associated pneumonia, bloodstream infections, or sepsis, the FDA said.

The most common were diarrhea, infusion site reactions, constipation, rash, candidiasis, cough, elevations in liver tests, headache, hypokalemia, nausea and vomiting.

Dive Brief:

• Metabolic, or bariatric, weight-loss surgeries ought to be taken seriously as a means to reduce incidence of major adverse cardiovascular events like heart failure, atrial fibrillation and heart attack, according to new research funded partly by Medtronic. The retrospective study was publishedMonday in the Journal of the American Medical Association and presented at the European Society of Cardiology Congress.
• “When balancing the imperfections in the evidence for both medical and surgical treatment of diabetes, the many benefits associated with bariatric surgery-induced weight loss suggest that it should be the preferred treatment option for carefully selected, motivated patients who are obese and have diabetes and cannot lose weight by other means,” JAMA Deputy Editor Edward Livingston wrote in a related editorial.
• Findings from the study must be confirmed in randomized clinical trials, researchers concluded.
• 

Dive Insight:

Medtronic markets a number of access and closure devices used in bariatric procedures, including visualization, dissection, suturing and stapling products. Almost 230,000 of the procedures, which make changes to the digestive system, took place in the U.S. in 2017. That was up from close to 160,000 in 2011, according to an estimate from the American Society for Metabolic and Bariatric Surgery. More than 100 million American adults, or close to one-third of the U.S. population, live with diabetes or prediabetes, per a 2017 report from the Centers for Disease Control and Prevention.

The Medtronic-supported study notes while metabolic surgery is thought to significantly improve cardiometabolic risk factors, which include diabetes, heart disease and stroke, the impact on cardiovascular outcomes hasn’t been as well-characterized.

Researchers sought to better understand the relationship between metabolic surgery and major adverse cardiovascular events, or MACE, using the Cleveland Clinic Electronic Health Record system. They retrospectively examined outcomes in 13,722 patients with diabetes, about 17% of whom underwent metabolic surgery between 1998 and 2017 and the rest of whom served as matched controls and received typical care for Type 2 diabetes and obesity. Median follow-up duration was 3.9 years.

Patients who had metabolic surgery showed favorable, statistically significant differences against the control group on each of the pre-specified secondary outcomes, which considered incidence of myocardial infarction, ischemic stroke, and mortality, as well as the six individual components of the primary endpoint — first occurrence of all-cause mortality, coronary artery events, cerebrovascular events, heart failure, nephropathy, and atrial fibrillation.

All-cause mortality occurred in 112 patients who received metabolic surgery and in 1,111 of the patients in the non-surgical group, the researchers reported. About 31% of the surgical group experienced one of those primary endpoints by the time of eight-year follow up; the rate was roughly 48% among the control group.

The Medtronic-backed research comes a little less than a year after a larger, NIH-supported study was published in JAMA that also found bariatric surgery to be associated with lower risk of major macrovascular events, and similarly called for confirmation through randomized clinical trials.

JAMA’s Livingston wrote in a related editorial that while medication is a universally accepted method for lowering glucose, bariatric surgery is not deemed “a first-line approach” for addressing diabetes in people with obesity.

“Compared with the large amount of clinical trial information available for drug treatment of diabetes, much less exists for bariatric surgery,” he wrote.

Livingston also noted limitations of the observational research included imprecise matching of the study groups, with the control group averaging slightly higher patient ages and diastolic blood pressures, in addition to having “much more” missing data.

“The results of this study should be interpreted with caution,” he wrote. “Although patients are referred to as ‘matched’ in observational studies, a more appropriate description is ‘similar.'”

The European Society of Cardiology Congress continues in Paris through Wednesday.

Dive Brief:

• Final results from the landmark Apple Heart Study, which studied if a heart-rate pulse sensor can be used to identify atrial fibrillation, were published by Stanford University researchers in the New England Journal of Medicine on Wednesday.
• The Apple-funded study that began with roughly 419,000 volunteers found a low likelihood of getting an irregular pulse notification. While researchers touted an apparent low incidence of false positives, many who didn’t receive a notification were subsequently diagnosed with AFib.
• Despite several limitations to the study, the Apple Heart Study results will help inform future large-scale research using wearable technologies, researchers said. On Thursday, Apple also launched its new research app, which is now enrolling participants for three new efforts: the Apple Women’s Health Study, the Apple Heart and Movement Study and the Apple Hearing Study.

Dive Insight:

The Apple Heart Study shows the promise of app-based health studies, but the development of ways to increase engagement and the accuracy of self-reported data is critical moving forward, said Mintu Turakhia, one principal investigator of the Apple Heart Study.

“These important findings lay the foundation for further research into the use of emerging wearable technologies in clinical practice and demonstrate the unique potential of large-scale app-based studies,” Turakhia, a cardiac electrophysiologist and executive director of Stanford’s Center for Digital Health, said in a statement.

Participants in the eight-month digital study wore an Apple Watch that monitored for irregular heart rhythms.

If an irregular pulse was detected, a telemedicine visit was prompted, followed by receipt of an EKG patch. All participants were asked to fill out an end-of-study survey.

Of the original participants, 2,161, or 0.52%, received a notification they had an irregular pulse. Notably, 1,711 of the people getting a notification were excluded from the study for various reasons, with 1,216 failing to initiate even the first telemedicine visit.

But of the 1,376 that returned a 90-day survey, 1,041, or 76%, said they contacted the study visit doctor or provider outside the study.

While researchers touted the low incidence of notifications sent to the study population — an indication of low false positives — a number of participants who didn’t receive a notification were diagnosed with AFib.

Of the 929 people that completed the end-of-survey study who got an irregular heart-rate notification, 404 received a new diagnosis of AFib. But of the 293,015 in the study who did not receive a notification and completed the end-of-study survey, 3,070 said they had since received a new diagnosis of AFib.

Researchers wrote the Apple Heart Study has “several limitations,” but noted it was not designed “to assess the algorithm as a screening tool or to measure sensitivity, specificity, or false positive results.”

“Participants did not initiate contact with the study provider after notification and fewer returned ECG patches (450 of 2161 notified) than anticipated,” the study states. “As a result, the targeted statistical precision for estimating the yield of atrial fibrillation on patch monitoring, which was one of our primary end points, was not met.”

The irregular heart-rate algorithm was meant to minimize false positive results, according to the study, a concern expressed by cardiologists prior to the release of the initial results in March.

The Apple Heart Study did not use newer Apple Watch’s electrocardiogram function, instead relying on a light signal function.

“Since rhythm-detection technologies are rapidly evolving, additional studies using features such as wearable ECG monitoring devices will need to be performed as the technology becomes available,” the study states.

With help from a wide-reaching FDA advisory committee meeting starting Wednesday, FDA is looking to expand its potential “toolbox” of methods to assess how a patient might respond to a metal implant.

“Our goal is to have a full set of effective tools that will predict adverse effects before implantation, for quantifying and visualizing adverse effects, or can quickly identify problems before they are clinically significant,” FDA said prior to the first public discussion of its kind exploring the safety of specific medical device materials.

In September, FDA released an approximately 150-page report on biological responses to metal implants, drawing on decades of findings since the mid-20th century when the first generation of hip implants hit the market. But it was a critical mass of adverse event reports related to high-profile, now-off-the-market products like birth control implant Essure and metal-on-metal hip replacement systems that drew greater attention to the subject.

The expert panel is tasked with highlighting areas with greatest need for research and suggesting next steps on how to better assess biocompatibility. A federal docket drew more than 280 comments ahead of the meeting, with many appearing to come from patients and patient advocates.

Over time, corrosion of devices can result in metal ions prompting an adverse tissue reaction surrounding the implant or in other parts of the body.

The agency will first need to gather a better understanding of which characteristics — in a device or in a person — might increase the likelihood of an adverse immunological or allergic response. Those variables may include an implant’s manufacturing, composition, coating, location and duration in a patient, as well as that patient’s sex, age, reproductive status and medical comorbidities.

The materials in question extend far beyond hips and birth control. At the crux of the discussion: At what level does each metal or alloy go from a safe, sometimes essential substance, to one that is toxic?

For example, cobalt, a naturally occurring metal, can in excess prompt cardiomyopathy and alter thyroid function, FDA outlined. And nickel, an example of a non-essential metal found in implants, may lead to acute symptoms like headache, vertigo, vision changes and GI distress, as well as cardiovascular, respiratory or kidney disease.

Nitinol (named for its combination of nickel and titanium), the material making up Essure, is used increasingly in devices like vascular stents for its superelasticity and ability to maintain its original shape amid temperature changes. The meeting’s purview covers metal- and metal alloy-containing devices spanning neurology, gastroenterology, urology and gynecology, and dentistry, too.

The agency’s review called out lofty challenges, including a fundamental lack of scientific understanding of the mechanisms potentially spurring the problems listed in myriad adverse event reports.

November 7, 2019 | TrialAssure today launched the limited release of ANONYMIZE R, a first-in-class document anonymization software that uses machine learning, natural language processing, and artificial intelligence to protect patient privacy by automatically finding and removing personal information from text.

ANONYMIZE R is intended for reports and documents, and it gives users the ability to apply rules that substitute information, reducing the possibility of a reader identifying a clinical trial patient. Using a powerful risk algorithm builder, ANONYMIZE R generates a re-identification risk score and produces a risk assessment report, ensuring that the anonymized document meets an acceptable risk threshold.

“When clinical trial data and documents are released to the public or research community, they are often prepared through different channels and at different times—leading to inconsistencies in the anonymization process. These inconsistencies limit the value of the information, because they reduce the ability for other researchers to effectively analyze all the available data,” said Zach Weingarden, Product Solutions Manager, TrialAssure, in a press release. “ANONYMIZE R solves this problem by allowing users to apply the same techniques to all clinical trial outputs, taking a holistic approach that ensures both consistency and efficiency. Aligning with regulatory guidelines, it drives its effectiveness with sophisticated, modern technology—replacing the age-old manual redaction process.”

How It Works

Through machine learning and AI, TrialAssure ANONYMIZE R uses natural language processing to extract information whenever text is transformed and feeds this data into machine learning algorithms. In doing so, ANONYMIZE R improves over time in identifying where and how text should be replaced. Before finalizing changes, users are encouraged to review all suggested anonymizations within its flagging system. Additionally, ANONYMIZE R leverages rules and machine learning applied from TrialAssure’s data anonymization module, ANONYMIZE DS, when both applications are implemented together.

“The only efficient way for organizations to meet the upcoming anonymization regulations is to use the latest technology with machine learning and AI functionality that learns your company preferences in real time,” said Mohamad Zahreddine, Chief Information Officer of TrialAssure, in the same press release. “Major global health authorities are beginning to ask that clinical documents be anonymized. Using ANONYMIZE R allows sponsors and researchers to meet these requests in a tech savvy, but budget-friendly, manner.”