industry news


Balloon-guided catheters provide better post-stroke blood flow, study finds

A multi-centre team of US researchers has found that balloon-guided catheter surgery can result in better outcomes for patients who have had a stroke due to brain artery blockages than conventional guided catheter procedures.

The study involved researchers from Boston University School of Medicine (BUSM), the Mercy Health Neuroscience Institute of Toledo, the University of Toledo and several other centres. It has been published in the Journal of NeuroInterventional Surgery and details how the researchers compared two groups of patients.

Co-author of the study Dr Mohamad Abdalkader said: “Stopping arterial flow is an important step that can improve restoration of blood flow, reduce the number of blood clot emboli to a new area and potentially improve clinical outcome.”

Strokes that are due to a blockage in one of the major brain arteries are referred to as large vessel occlusions (LVO). The typical treatment for LVO is clot retrieval and doctors can use either a balloon-guided catheter or a conventional guided catheter to do this.

During the study, one group of LVO stroke patients underwent treatment with a stent retriever with a balloon-guided catheter. The balloon on the guide catheter temporarily inflates while in the carotid artery to stop blood flow as the clot is being removed. In the second group, LVO patients underwent treatment with a stent retriever using a conventional guide catheter.

Corresponding author Dr Thanh Nguyen said: “When we compared both groups, patients who had balloon-guided catheter had better restoration of blood flow scores and better clinical outcomes.”

Senior author Dr Osama Zaidat said: “Achieving complete or near complete blood flow is the goal to restore strength, language, coordination, reflexes and sensation to patients suffering from ischemic stroke.”

University of Toledo professor and co-author of the study Dr Alicia Castonguay added: “Our study adds to the growing body of evidence that highlights the potential of balloon-guide catheters to improve stroke patient outcomes. Future studies are necessary to fully understand the role of this technology in a larger patient population.”


FDA issues warning on accuracy of Roche’s warfarin test strips

The US Food and Drug Administration (FDA) has issued a warning that certain Roche Diagnostics test strips used with a CoaguChek test meter device to monitor warfarin levels may deliver inaccurate results.

Medical product distributor Terrific Care/Medex Supply voluntarily recalled certain lots of the home-use test strips.

Classifying the recall as Class I, the FDA warned patients and doctors to not rely on results from these test strips to adjust the warfarin dosage. The drug is a blood thinning medication used to address blood clots.

Venous thromboembolism (VTE) is a condition that results in blood clots forming in veins. Blood clots are life-threatening and must be treated quickly. Anticoagulants medications such as warfarin are often used to prevent blood clots from happening in high-risk patients.

The recalled CoaguChek XS PT Test Strips, manufactured by Roche and distributed by Terrific Care/Medex Supply, were not authorised for sale in the US.

According to the FDA, Terrific Care/Medex Supply purchased the test strips from an unknown source and imported them to the US.

FDA Commissioner Scott Gottlieb said: “Using faulty strips can lead to errors in medication dosage that could cause serious harm or death in some patients. That’s why it’s so concerning that this distributor continued to sell these test strips in the US even though domestic sales had been stopped due to safety concerns.

“Distributing products that are not labelled or authorised for sale in the US raises significant concerns for us in view of the serious safety issues with these test strip devices, and our work on this matter is not finished.”

In November last year, Roche recalled more than 1.1 million packages of CoaguChek XS PT Test Strips distributed between 12 January and 29 October 2018.

The recall was attributed to inaccurate INR test results when compared to laboratory results.

Incorrect INR results, which affect warfarin dosage, could be a concern for patients who are at an increased risk of blood clots, such as people with mechanical heart valves, atrial fibrillation and are at high risk of having a stroke or have had a recent blood clot.


Sirakoss’ Osteo bone graft substitute obtains CE-Mark

UK-based Sirakoss has received CE-Mark clearance for the use of its new nanosynthetic bone graft substitute Osteo, which improves healing in patients who require bone fractures repair.

Synthetic bone grafts are used to fuse bones during surgery in order to correct congenital or degenerative conditions, or after a traumatic injury that has affected the healing of a bone.

Osteo leverages nanoporous technology and features an inorganic matrix that can be completely reabsorbed into the bone.

The graft substitute’s design focuses on catalysis of fast and complete bone regeneration after a fracture, as well as to support the skeletal system following corrective surgery of a degenerative or deformity condition.

Under the CE-Mark, Osteo is indicated as a bone graft material for filling voids of the skeletal system. It can be used alone or in combination with an autograft or allograft.

Sirakoss co-founder and R&D director Iain Gibson said: “We designed Osteo to address an increasing demand for a bone graft substitute that has the efficacy of autograft but overcomes the well-reported problems of donor site pain for a significant number of patients.”

The company noted positive results from studies conducted to assess its new synthetic bone graft. Sirakoss intends to provide additional safety and effectiveness of clinical data for the product.

Sirakoss director Tom Buckland said: “The positive results in studies achieved to date suggests that Osteo is a potential gamechanger in the synthetic bone graft substitute market, providing significant advantages to patients and surgeons, including in the most challenging bone fracture indications.

“Sirakoss’ priority is executing on its commitment to delivering robust clinical data demonstrating safety and effectiveness of this exciting new product.”

The company is currently developing further generations of the product to offer additional benefits such as intraoperative ease-of-use.

31 JANUARY 2019

London-based tech start-up uses AI to detect warning signs of dementia

London based start-up Cognetivity Neurosciences has published research indicating that artificial intelligence could be used to detect early-stage dementia.

The study reveals that the firm’s Integrated Cognitive Assessment (ICA) platform could help detect warning signs of neurodegenerative conditions. The peer-reviewed findings have been published in Scientific Reports.

The ICA is a digital cognitive assessment test conducted via an iPad and completed in around five minutes. Researchers presented subjects with 100 greyscale images, 50 animal and 50 non-animal, in rapid succession. They then had to categorise each of these accordingly as they were displayed, and were given a score based on their speed and accuracy.

All parts of the visual system may be impacted by dementia and similar cognitive impairments, such as Huntington’s disease. The human motor cortex and oculomotor may also be impacted. These functionalities may be affected up to ten to 20 years before the onset of discernible cognitive impairment in neurodegenerative patients.

Alzheimer’s Research UK’s Director of Research Dr Carol Routledge said: “Rather than diagnosing when patients already have memory loss, problems with thinking, and real cognitive dysfunction, [the ICA] will take the diagnosis way back.”

In measuring all three, the ICA allows patients to be diagnosed before the irreversible neuronal death associated with neurodegenerative diseases.

Dr Routledge added: “Unless we diagnose early, I don’t think we’ll have effective treatments, and if we don’t get effective treatments the prognosis of patients it going to remain exactly where it is now.”

The accuracy of individual ICA test scores correlated significantly with the accuracy of cognitive tests currently used in clinical practice. This included the Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and Addenbrooke’s Cognitive Examination (ACE).

According to Cognetivity Neurosciences the ICA is more appropriate for large-scale, proactive cognitive monitoring than these traditional methods. This is because the test can be completed without the input of a healthcare professional, and avoids becoming language or education dependent, or exhibiting learning bias.

Cognetivity CEO and director Dr Sina Habibi said: “It is our aim to make our technology available to help as many people as possible, whether through its use in clinical environments for the crucial early detection of conditions such as dementia, or through allowing people to measure their ongoing cognitive performance as part of their overall health monitoring activities.”

31 JANUARY 2019

Inflatable pill could offer long-term tracking of stomach conditions

A team of engineers from the Massachusetts Institute of Technology (MIT) in the US has developed an inflatable pill that swells in the stomach and monitors the organ’s temperature for up to a month.

To enable continuous tracking, a temperature sensor has been embedded into the pill.

The pill’s design is inspired by the defence mechanisms of the pufferfish (blowfish). It is made of mixtures of hydrogel polymers and water that contribute to its Jell-O-like consistency.

According to the team, the combination allows swelling in the stomach and protects the pill from the acidic environment.

The use of hydrogel is intended to make the device soft, biocompatible and long-lasting compared to existing ingestible sensors that can remain in the stomach for only days or are made of plastic or metal.

The pill can be removed by giving a patient a solution of calcium, which shrinks the device back to its original size and allows it to pass out safely from the body.

MIT mechanical engineering associate professor Xuanhe Zhao said: “The dream is to have a Jell-O-like smart pill that once swallowed stays in the stomach and monitors the patient’s health for a long time such as a month.”

The researchers tested the inflatable pill in a laboratory setting, where they immersed it in different water solutions and fluid similar to gastric juices. They observed that the pill swelled to 100 times its original size in approximately 15 minutes, which is considered faster than existing swellable hydrogels.

In order to assess the device’s toughness to withstand stomach churning, the team mechanically squeezed it numerous times and found the pill to be intact.

The researchers then inserted small, commercial temperature sensors into multiple pills and fed them to pigs. Analysis of the sensors’ temperature measurements demonstrated its ability to accurately monitor the animals’ daily activity patterns for up to 30 days.

It is expected that the ingestible, inflatable pill will have a variety of medical applications, including the tracking of pH levels or signs of certain bacteria or viruses in the stomach, based on the embedded sensor.

The researchers also believe that insertion of tiny cameras will allow the pill to image the progress of tumours or ulcers over several weeks.

They additionally said that the pill could potentially be used as an alternative to the gastric balloon, which is inserted into the stomach for weight loss.

30 JANUARY 2019

AI provides accurate and reliable heart disease prognosis, study finds

Researchers at Cardiff University in the UK have demonstrated that artificial intelligence (AI) is just as accurate as traditional methods at providing an accurate and reliable prognosis of cardiovascular disease.

The study has been published in PLOS ONE, and details how using machine-learning techniques could save the time of oversubscribed health services as no expertise or human interaction is required.

Co-author of the study Professor Craig Currie said: “If we can refine these methods, they will allow us to determine much earlier those people who require preventative measures. This will extend people’s lives and conserve NHS resources.”

Traditionally, clinicians and statisticians have worked out a prognosis of cardiovascular disease for a patient by manually developing mathematical equations.

Currie added: “Although we already have reliable methods of forecasting people according to their degree of risk of serious heart events, artificial intelligence promises new ways of interrogating data and the likelihood of more reliable classification of risk.”

In the study, the research team trialled a technique called genetic programming (GP). GP is a method that involves computer programs encoding a set of genes that are then iteratively modified or evolved.

GP is said to be better than algorithms produced by humans because it reduces bias and the possibility of human error while allowing for any changes in the environment to be automatically integrated into mathematical formulas.

Complex associations uncovered by AI from the data can be made transparent to clinicians, meaning that there is no need for them to diverge from their existing practice.

During the Cardiff University study, GP was used to assess the future risk of a cardiovascular event in over 3,800 cardiovascular patients, aged between 19 and 83 years old, over a ten-year period.

The machine-learning algorithms relied on 25 predictors taken from patient data, including age, BMI, sex, alcohol and smoking habits and blood pressure. The results showed that the AI could perform comparably to traditional methods when predicting the risk associated with individual patients.

Cardiff University professor and co-author of the study Professor Irena Spasic said: “The ability to interpret solutions offered by machine learning has so far held the technology back in terms of integration into clinical practice.

“However, in light of the recent resurgence of neural networks, it is important not to sideline other machine learning methods, especially those that offer transparency such as genetic programming or decision trees. After all, we are looking to use artificial intelligence to aid human experts and not to take them out of the equation altogether.”

29 JANUARY 2019

Accuray forms JV to offer radiation oncology systems in China

US-based radiotherapy systems developer Accuray has formed a joint venture (JV) with China Isotope and Radiation Corporation (CIRC) to manufacture and sell radiation oncology systems in China.

The deal has been signed by Accuray unit Accuray Asia and China Isotope division CNNC High Energy Equipment, which will own 49% and 51% of the JV, respectively.

The new entity will operate as CNNC Accuray Medical Technology in Tianjin, China. It will cater to the emerging radiation oncology systems market and longer-term unmet needs in the country.

In addition, the JV will leverage both Accuray and CIRC capabilities to offer locally branded and manufactured radiation therapy products.

CNNC Accuray Medical Technology will focus on delivering a complete suite of radiation therapy and radiosurgery treatments for Chinese medical professionals and patients.

Accuray president and CEO Joshua Levine said: “Today’s announcement, which follows an extensive, 18-month evaluation process, advances Accuray’s mission to bring innovative, life-saving radiation products to cancer patients.

“We believe that by uniting CIRC’s strong market access, significant local manufacturing experience and extensive infrastructure in China combined with Accuray’s precise, innovative treatment solutions, the JV will be ideally positioned to effectively address unmet patient needs and improve lives in the world’s largest market for radiation oncology.”

The JV is scheduled to start sales operations by the end of 2019. Until then, Accuray’s existing Chinese distributor will be responsible for orders and revenue.

Accuray primarily develops, manufactures and sells radiation oncology systems for the treatment of cancer. The company offers treatment delivery technologies that are designed to enable precision.

28 JANUARY 2019

Artificial pancreas smartphone app yields positive study data

A team of researchers in the US has reported positive results from a clinical study evaluating the use of an artificial pancreas system smartphone app (iAPS) in regulating blood glucose levels.

iAPS is designed to wirelessly interface with continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms. It runs on an unlocked smartphone.

The app comes with a user interface, which allows patients to interact with their devices, request an insulin bolus for a meal or correct and log different activities.

iAPS also displays the current glycemic status and enables remote monitoring.

Conducted in partnership with Sansum Diabetes Research Institute, Joslin Diabetes Center and Labrasoft, the study evaluated the app in six type 1 diabetes patients.

Results showed that the app was safe and effective in regulating glucose levels, with improvements in the target glucose range 70-180mg/dL and a statistically significant decrease in time below 70mg/dL.

iAPS demonstrated strong connectivity with peripheral devices.

In a separate development, the National Institutes of Health (NIH) has awarded a grant to develop and assess a pregnancy-specific artificial pancreas in multiple clinical trials.

The project is being carried out by the Harvard John A. Paulson School of Engineering and Applied Sciences, Icahn School of Medicine at Mount Sinai, Mayo Clinic and Sansum Diabetes Research Institute.

It will evaluate the use of artificial pancreas technology to maintain glucose levels in type 1 diabetes mothers in order to improve outcomes for babies

Diabetes in pregnancy can either be gestational if pregnancy hormones result in a mother developing a resistance to insulin, or pregestational in pregnant patients who already have insulin-dependent diabetes. Both types can be bad for a baby’s health and can result in hypoglycemia, macrosomia, birth injuries and respiratory distress for both the mother and baby.

Mayo Clinic Rochester endocrinology professor Yogish Kudva said: “Women with type 1 diabetes experience significant insulin reactions as they try to manage their glucose within a narrow target range throughout pregnancy. There has been no artificial pancreas trial involving pregnant women with type 1 diabetes in the US.

“We are excited that we will adapt automated insulin delivery to relieve the burden on pregnant women with type 1 diabetes and their families.”