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Implantable, Light Activated Drug Releasing Microchamber Arrays

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A research collaboration between scientists in Singapore, Russia, and the UK has developed a way of building tiny microchambers that can release drugs when activated by light.

The microchambers are packaged together into implantable arrays that, when illuminated by near-infrared light, will open up and let whatever is inside flow out. They’re made from a mix of polymers and graphene oxide using two techniques called nanoimprint lithography and layer-by-layer assembly, both perfected at Agency for Science, Technology and Research (A*STAR) in Singapore.

The wavelength of light that is used to open up the chamber is safe enough for therapeutic purposes, not heating up or damaging the tissue on the way to the implant.

“This near-infrared light is the perfect way to trigger drug release as it has the maximum penetration into biological tissues,” said Maxim Kiryukhin from the A*STAR Institute of Materials Research and Engineering.

This work is still in progress and there’s a long way to go before it reaches the clinical stage, but the principle is exciting and may allow for long-term timely delivery of various drugs for many diseases.

Study in Macromolecular Rapid Communications: Polyelectrolyte–Graphene Oxide Multilayer Composites for Array of Microchambers which are Mechanically Robust and Responsive to NIR Light…

Via: A*STAR…


myLAB Box STI at-home Test Kits. Interview with Lora Ivanova, Co-Founder and CEO at myLAB Box

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myLAB Box, a healthcare company based in California, has developed and pioneered an at-home sexually transmitted disease (STD) testing service. With the number of STDs rising, the Centers for Disease Control and Prevention estimates that nearly 20 million new STDs occur annually in the US, and half of these are in people aged 15 to 24.

STDs are often symptomless, but can have significant consequences. For instance, an estimated 24,000 women become infertile every year because of undiagnosed STDs. An estimated 80% of sexually active people will have a human papillomavirus (HPV) infection at some point in their lives, and HPV causes approximately 31,500 cases of cancer each year.

Regular testing can help prevent the spread of STDs, but unfortunately many people skip these tests, largely because of stigma, cost, or time. In fact, although half of new STD cases occur in young people, only 12% of such people were tested within the last year.

myLAB Box aims to overcome these hurdles by providing at-home testing kits that allow people to discreetly test for STDs on their own time and in the comfort and privacy of their own home. Users can then get a free telephone medical consultation if they receive positive test results, giving privacy and providing useful advice and how to move to the next steps. The company claims that it takes just five minutes to perform the test, and then users will receive their lab-certified test results within five days.

Medgadget asked Lora Ivanova, Co-Founder and CEO at myLAB Box, some questions about the concept.

 

Conn Hastings, Medgadget: Please give us some background on the scale of the STD issue, and the consequences that undiagnosed STDs can have.

Lora Ivanova, myLAB Box: The STD crisis in the United States is not receiving the attention that it should. The Center for Disease Control and Prevention tallied nearly 2.3 million cases of chlamydia, gonorrhea and syphilis in 2017 – an increase of more than 200,000 cases over the previous year – and a record high. In fact, rates have continued to rise over the past four years despite efforts to educate people on the importance of regular testing.

If STDs are left untreated, many easily curable infections such as chlamydia, gonorrhea and bacterial vaginosis can lead to pelvic inflammatory disease in women and infertility in both men and women, as well as other serious health complications. Since these infections are common, it is recommended that sexually active individuals get tested for them on a regular basis to prevent unknowingly infecting a partner, potentially endangering pregnancy and developing long-term or even fatal health consequences.

Discussing sexual health with your partners can be an awkward conversation to have. By delivering tests to your mailbox, we’ve helped remove a mental barrier preventing you from getting tested while making screening more convenient and accessible

 

Medgadget: Why are STDs on the rise? Are rates of detection and treatment also increasing?

Lora Ivanova: A driving factor for this rise in rates is that people are simply avoiding STD testing in the first place. Failure to stem these infections includes lack of sex education, cost, the inconvenience of driving to a lab, clinic or doctor’s office, and the taboo that this topic still carries.

There are many misconceptions when it comes to contracting and detecting STDs. More than 80% of infections are asymptomatic and can mimic the common flu or headaches. Many also believe that STDs can be avoided by having oral or anal sex, though the reality is that where there is sex, there can be STDs. It is not just the sexually promiscuous who are at risk.

The new ways that we find our partners is also a factor. The popularity of online dating means that people are engaging with others far outside their natural social circles, and disease follows. Research has found that those who found their partners online are three times more likely to contract an STD than those who did so the old-fashioned way.

Funding cuts and the changing insurance landscape have also been affecting public-health centers and STD-prevention-and-treatment programs throughout the United States in recent years. Due to cuts, many of these initiatives have decreased their staffing and hours, sometimes closing altogether, making STD detection and treatment more difficult.

Lastly, condoms are falling out of favor as the birth control method of choice. The CDC found that 24 percent of women and 34 percent of men said they’d used condoms during their last sexual intercourse, with 55 to 60 percent of both groups stating that condoms were their only form of contraception. These statistics are disheartening since condoms, while not perfect, can help prevent many different types of STDs. PrEP, a pill to protect people from the AIDS virus, may also be lulling people into a false sense of security as condom usage declines. While a serious infection, HIV is not as common as other forms of STDs which are preventable with condoms.

 

Medgadget: What components are included in the myLAB Box test kit, and is the test difficult, invasive, or time-consuming?

Lora Ivanova: We work with the top sexual health experts and testing facilities in the U.S. to bring STD screening to your doorstep in a discreet package. Tests can be self-administered in as little as 5 minutes. Simply mail in a small bio sample (urine, swab or tiny finger prick) in the pre-addressed envelope provided and receive lab-certified results back electronically in a matter of days. We make it that easy!

The process is very simple:

  1. Order Online – No need to go to a lab or book appointments.
  2. Test at Home – Collect and mail your sample in under 5 minutes.
  3. Get Results – Results are as accurate as those obtained in clinics.
  4. Free Consultations – Same-day physician phone consultations for positives.

 

Medgadget: What STDs can the kit detect? Is the accuracy of the kit comparable to conventional STD testing?

Lora Ivanova: myLAB Box offers the most comprehensive at-home STD screening platform on the market, featuring tests for 15 sexual health infections.

All tests are validated by myLAB Box clinical laboratory affiliates and results are comparable to samples collected in a physician’s office or clinical laboratory.

 

Medgadget: What happens if someone tests positive? Does myLAB Box refer them to a local doctor if prescription medication is required?

Lora Ivanova: All who test positive using the myLAB Box service are entitled to a complimentary phone consultation with a myLAB Box medical affiliate to be evaluated for the treatment of chlamydia, gonorrhea and trich. Depending on your symptoms at the time of consultation, the physician may be able to send a prescription to the pharmacy of your choosing immediately, dramatically shortening the time it takes to test and treat and minimizing the chance for complications or infecting others. All myLAB Box test results are lab-certified so you can also take them to your personal physician or clinic for treatment if you prefer.

 

Medgadget: How has the kit been received by users so far?

Lora Ivanova: Feedback has been overwhelmingly positive. Many of our customers are busy professionals who appreciate the convenience and time saved by being able to order a test online and take it from the comfort and privacy of their home. Others appreciate the peace of mind. Whether male or female, gay or straight, young or old, myLAB Box customers are diverse, from all walks of life, and want to take control of their sexual health.

From affordable screening to complimentary physician consultations for positives, every aspect of the myLAB Box service is designed to be something a user can easily handle out-of-pocket. The recent shake-up of our healthcare systems further deepens our resolve to grow our offering and develop a new hassle-free lab testing model. We believe this is not just great business, but a much-needed resource to curb a widespread epidemic.

Link: myLAB Box…

Hairy Coating Keeps Nanoparticles Safe from Immune System, Liver

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Nanoparticles are seemingly a great way to treat tumors, but they’re so rapidly washed out by the bloodstream that few of the nanoparticles actually reach their targets. Researchers at Drexel University have now developed a surface treatment that gives nanoparticles a significant advantage to overcome the body’s filtration system and therefore make nanotherapies much more effective.

The researchers developed hairy polymer shells within which nanoparticles can be encapsulated, and which the immune system ignores, while the liver lets the shells circulate back into the bloodstream.

Plasma proteins are a primary way for the body to tag which objects the immune system should get rid of, and macrophages then act to remove them. Turns out that sinusoidal endothelial cells of the liver are also responsible for removing tagged objects, a recent finding of the Drexel research team.

They also showed that a coating of polyethylene glycol hairs keeps the plasma proteins away, not letting them tag the nanoparticles. Additionally, having sections that are even denser than the hair-like surface prevents the liver from filtering them out, and using both techniques on the same nanoparticles lets them remain in the bloodstream for a long time.

Study in ACS Nano: Dense and Dynamic Polyethylene Glycol Shells Cloak Nanoparticles from Uptake by Liver Endothelial Cells for Long Blood Circulation…

Via: Drexel University…

Barco’s New 27″ 4K Surgical Monitor

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Barco is releasing a new 4K surgical monitor that’s designed to give clinicians a high fidelity live image during interventional procedures. The Barco MDSC-8427 has a 27” screen, providing a new, larger size over common 24″ and 26″ monitors.

The display features the company’s smart image processing technology optimized to improve how live video comes through. A wide color gamut and built-in color calibration help to reproduce the surgical scene accurately. A wide viewing angle gives everyone around the operating room a clear picture with minimal distortion.

The MDSC-8427 can be mounted on a cart alone or in a dual-display configuration on a surgical boom.

It has a bunch of connectivity options, including DP, HDMI, 12G-SDI, Quad-SDI, and IP, so all kinds of devices like endoscopic cameras, computers, and such, can be connected to it.

“The new MDSC-8427 is a first in our next generation of 4K displays for the operating room,” said Johan Stockman, Barco’s VP surgical imaging, in a statement. “Careful consideration went into the new design. We wanted to create a display that combines surgical aesthetics with surgical precision. This new paradigm of display design shows how fine form can meet function in the operating room”.

Product page: MDSC-8427…

Via: Barco…

MRI Helps to Optimize Vagus Nerve Stimulation for GI Conditions

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Vagus nerve stimulation to address various gastrointestinal conditions is already an approved FDA therapy. While effective in many people, it is hard to understand the mechanism of such treatment and to tune it well for each individual patient.  Researchers at Purdue University are now utilizing MRI scanning to actually see what effect nerve stimulation has on the stomach.

The team manipulated the pyloric sphincter, which controls stomach emptying, in lab rats by stimulating the vagus nerve. At the same time, they used an MRI scanner to image the activity of the stomach. Animations were created using the scans that demonstrated that the stimulation indeed relaxed the pyloric sphincter.

The researchers envision patients coming in for one or more sessions in an MRI machine, in order to test different stimulation protocols and to narrow down which are the most effective for a given patient.

“Some stimulation protocols for the stomach in humans already have FDA approval, but they’ve proved only partially effective,” said Terry Powley, Purdue’s Distinguished Professor of Neuroscience and the director of the SPARC (Stimulating Peripheral Activity to Relieve Conditions) project. The researchers hope that their approach will open the possibilities of nerve stimulation for other GI conditions.

Here’s a video from Purdue about the research:

Study: Vagus nerve stimulation promotes gastric emptying by increasing pyloric opening measured with magnetic resonance imaging…

Via: Purdue…

Flexible LED Sensor Monitors Blood-Oxygenation Levels Through Skin

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Researchers at University of California Berkeley have developed a flexible sensor that can be placed on the skin to measure levels of blood oxygenation over a large area. The device could help in tracking wound healing, or in monitoring oxygenation levels in transplanted skin or organs.

“When you hear the word oximeter, the name for blood-oxygen sensors, rigid and bulky finger-clip sensors come into your mind,” said Yasser Khan, a researcher involved in the study. “We wanted to break away from that, and show oximeters can be lightweight, thin and flexible.”

In traditional finger-clip oximeters, LEDs shine near-infrared light through the skin. As red, oxygen-loaded blood absorbs more infrared light than deoxygenated blood, the sensor detects how much light makes it through the tissue, which gives an indication of blood oxygenation. However, this means that the sensor can only be applied to relatively thin and transparent appendages, such as the finger or ear lobe.

“Thick regions of the body, such as the forehead, arms and legs, barely pass visible or near-infrared light, which makes measuring oxygenation at these locations really challenging,” said Khan.

Instead of measuring light that is transmitted through tissue, the new sensor measures reflected light. This means that it can be applied anywhere on the body and can measure blood oxygenation at nine points in a grid, providing a more complete picture of local oxygenation.

The new sensor consists of an array of red and near-infrared LEDs printed on a flexible surface. The researchers have tested it on the forehead and forearm of volunteers, and found that it provides blood oxygenation readings that are comparable to a traditional finger-clip oximeter.

“All medical applications that use oxygen monitoring could benefit from a wearable sensor,” said Ana Claudia Arias, another researcher involved in the study. “Patients with diabetes, respiration diseases and even sleep apnea could use a sensor that could be worn anywhere to monitor blood-oxygen levels 24/7.”

“After transplantation, surgeons want to measure that all parts of an organ are getting oxygen,” Khan said. “If you have one sensor, you have to move it around to measure oxygenation at different locations. With an array, you can know right away if there is a point that is not healing properly.”

Study in Proceedings of the National Academy of Sciences: A flexible organic reflectance oximeter array

Via: UC Berkeley

3M’s New Durapore Advanced Surgical Tape for Keeping Tubes in Place

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3M is releasing a new surgical adhesive tape that was developed to address special needs for a variety of clinical applications. The 3M Durapore Advanced tape is particularly beneficial when securing critical tubes that have to stay in place without a danger of being moved (chest tubes, JP drains, etc).

The new product line adheres to skin, various tubes, and to itself, and when the surface is moist, having different textures, and in humid environments the tape is designed to perform well. The tape sticks on evenly throughout the surface, lifting very little at the edges.

The tape has no natural rubber latex, but 3M claims it sticks on better than tapes that rely on latex.

Product page: 3M Durapore Advanced Surgical Tape…

Via: 3M…

MRI Used to Study How Beatboxers Make Sounds

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Beatboxers can make some pretty wild sounds, from deep bass thumps to snare drum cracks. How they do it is very much a mystery because the vocal chords and everything around them is hidden behind layers of tissue. Researchers at University of Southern California are using an MRI scanner to study this matter with the help of real beatboxers.

The investigators are able to identify various markers of different sound types on MRI scans and see how the anatomy affects the sounds that are produced. The research is being presented this week at the ongoing Acoustical Society of America’s 176th Meeting in Victoria, Canada.

The team looks at the vocal tracts of the beatboxers before sounds are produced and compare how the movement differs from normal speech. They use real-time imaging techniques to see the dynamics of this movement in details previously unstudied.

Here’s an example video from one of the studies:


Via: Acoustical Society of America…

Cios Spin Mobile 3D C-Arm for Orthopedic Surgery

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Siemens Healthineers has unveiled a new mobile C-arm, the Cios Spin, that can provide both 2D and 3D imaging in just about any operating room. Mostly intended for orthopedic procedures, the device allows clinicians that are currently using 2D C-arms to upgrade to 3D capability and see things in a much more intuitive perspective. Positioning implants and driving screws into bones requires great accuracy and a clear understanding of the tissues being worked.

The Cios Spin features the company’s Retina 3D scan technology, an imaging volume of 16 cubic centimeters (8 cm on a side), metal artifact reduction, and iso-centric technology. Siemens Healthineers claim it provides “outstanding 3D image quality in heavy patients” thanks to 25 kW of output power with up to 250 mA tube current and Simens’ “Energy Storage Unit” which seems to be a powerful capacitor that can provide thrice the applicable power at any time.

3D scans take no more than 30 seconds and preparation is purportedly intuitive and quick on a touchscreen display. The system automatically identifies screws within the 3D scans and immediately offers an optimal view to the localized screws.

Product page: Cios Spin…

Via: Siemens Healthineers…

Glaucoma Drainage Device Uses Magnetic Fields for Self-Cleaning

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Researchers at Purdue University have designed a prototype glaucoma drainage device that can clean itself under the influence of external magnetic waves. The innovation could lead to ocular drainage implants that last significantly longer than current models.

The CDC has reported that approximately three million Americans are living with glaucoma. At present, clinicians prescribe medications, or advise that patients undergo surgical implantation of a drainage device to relieve the pressure build-up in the eye and restore sight. However, these approaches offer varying degrees of success.

One of the problems is that implantable drainage devices have a limited lifespan, as they become blocked and ineffective through a buildup of microorganisms, which is known as biofouling. Only 50% of the devices are still functional after five years.

“We created a new drainage device that combats this problem of buildup by using advances in microtechnology,” said Hyowon “Hugh” Lee, a researcher involved in the study. “It is able to clear itself of harmful bio-buildup. This is a giant leap toward personalized medicine.”

The new drainage device contains micro-actuators that vibrate when influenced by magnetic fields. Each actuator consists of an anchor and a nickel magnet. The device can clear itself of microbial biofouling when the vibrating actuators scrape the walls of the drain and break the blockage apart. Because the magnetic fields can be applied externally, the cleaning technique is minimally invasive.

“We can introduce the magnetic field from outside the body at any time to essentially give the device a refresh,” said Lee. “Our on-demand technology allows for a more reliable, safe and effective implant for treating glaucoma.”

The drainage device can also allow for varying flow resistance, which means that it can provide customized treatment for each glaucoma patient. Glaucoma varies depending on the stage of the disease, and patients may have different requirements in terms of pressure build-up in the eye and the optimal drainage parameters to alleviate it. So far, the researchers have tested their prototype device in the lab and are now working to patent and license it.

Study in Microsystems and Nanoengineering: Towards smart self-clearing glaucoma drainage device…

Via: Purdue University…

University of Missouri Research Reactor Now Supplying Iodine-131 for Thyroid Treatment

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Medical radioisotopes are widely used in cancer treatment, but their production has been hampered to the point that obtaining them has become a challenge. The lack of Technetium-99m is probably the most widely known, but there’s also a shortage of Iodine-131 (I-131), a radioisotope commonly used for diagnosing and treating thyroid conditions because the thyroid absorbs iodine naturally.

Things are now looking up as the University of Missouri Research Reactor (MURR), a 10 megawatt reactor, has just produced the first commercial batch of I-131.  International Isotopes, Inc. is the buyer and distributor. This is the first supplier of I-131 to be based in the United States since the 1980s, and so should help to guarantee the availability of the radioisotope for many years. It was first approved by the FDA in 1951, but because of a half life lasting just over a week, the material requires constant and consistent production.

“Having MURR as a domestic producer for I-131 provides a much higher level of stability and reliability in the U.S. for this important isotope,” said Steve Laflin, president and CEO of International Isotopes, Inc. (INIS). “INIS has been supplying I-131 throughout the U.S. for nearly 15 years using only foreign sources of supply. We are pleased to have an opportunity to enter into a long-term supply agreement, and INIS plans to utilize MURR as one of our major suppliers for I-131 in the future.”

Flashbacks: U.S. to Get Its Own Supply of Radioisotopes Thanks to Approval of RadioGenix System…Lantheus Announces First Technetium-99m Isotope Generator from Low Enriched Uranium…Nuclear Scientists Devise New Methods to Produce Medical Radioisotopes…New South African Source for Molybdenum-99 to Soothe Supply Worries in Medical Radioisotope Market…

 

DNA Origami Nanoparticles to Treat Acute Kidney Injury

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DNA origami is a technique for building different shaped molecules out of the four standard nucleotide bases. Various forms can be constructed, such as tubes, pyramids, and cubes, and the shapes of these molecules can significantly affect their functionality. Now they’ve been shown to be useful for treating acute kidney injury (AKI).

The DNA origami nanostructures (DONs), that researchers at University of Wisconsin-Madison, Arizona State and a few institutions in China have developed, have been shown to protect kidneys from succumbing to AKI and to heal already injured kidneys. The effect was comparable to the current standard of care, namely an anti-oxidant N-acetylcysteine (NAC).

The research was performed on mice as well as as on human embryonic kidney cells, and the technique was shown to be effective in both.

“The interdisciplinary collaboration between nanomedicine and the in-vivo imaging team led by professor Weibo Cai at the University of Wisconsin-Madison and the DNA nanotechnology team has led to a novel application—applying DNA origami nanostructures to treat acute kidney injury,” Yan says.  “This represents a new horizon for DNA nanotechnology research.”

In the study, in order to show where the DNA nanostructures are located and congregate in what numbers, positron-emission tomography (PET) imaging was used. This helped to identify the concentrations of the DNA origami nanoparticles that are best for treatment and which shapes are most suited.

Study in Nature Biomedical Engineering: DNA origami nanostructures can exhibit preferential renal uptake and alleviate acute kidney injury…

Via: Arizona State…

Tiny New Pacemaker Small Enough for Infants

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Researchers at Children’s National Health System, working with engineers from Medtronic, have created a pacemaker appropriately tiny enough to implant into infants. Measuring only one cubic centimeter, about the size of a large pill, it allows the device to be implanted inside the child in a minimally invasive fashion.

Currently, because of their size, pacemakers implanted into very small children either remain outside the body or require open surgery with large incision. The new pacemaker is so small that a one centimeter incision is all that’s necessary to place it under the ribcage.

The incision is used not only for the pacemaker, but through which the electronic lead is delivered through and attached to the pericardium. The procedure is much faster, less invasive, and results in less pain and quicker recovery for the children. Of course, the overall costs of the procedure and follow up treatment should be reduced as well.

“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first,” said Rohan Kumthekar, M.D., one of the docs at Children’s National that worked on the new device and ways to implant it. “Advancements in surgical fields are tending toward procedures that are less and less invasive. There are many laparoscopic surgeries in adults and children that used to be open surgeries, such as appendix and gall bladder removals. However, placing pacemaker leads on infants’ hearts has always been an open surgery. We are trying to bring those surgical advances into our field of pediatric cardiology to benefit our patients.”

The research, so far, has been performed on infant models, but work is moving toward clinical trials that may end up revolutionizing how infant cardiac arrhythmias are treated.

Here are some more details according to Children’s National:

With the help of a patented two-channel, self-anchoring access port previously developed by [Dr. Charles Berul’s] research group, the operator can insert a camera into the chest to directly visualize the entire procedure. They can then insert a sheath (narrow tube) through the second channel to access the pericardial sac, the plastic-like cover around the heart. The leadlet, the short extension of the miniature pacemaker, can be affixed onto the surface of the heart under direct visualization. The final step is to insert the pacemaker into the incision and close the skin, leaving a tiny scar instead of two large suture lines.

The median time from incision to implantation in this thoracoscopic surgery study was 21 minutes, and the entire procedure took less than an hour on average. In contrast, pediatric open-heart surgery could take up to several hours, depending on the child’s medical complexities.

Via: Children’s National…

Nanoneedle Skin Patch to Inject Drugs Into Cells

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Delivering drugs directly into skin cells using microscopic nanoneedles may allow for highly effective treatment of skin conditions without injuring the cells that are treated. Silicon nanoneedles have been developed in the past that can do such a trick, but they’re stiff and can be painful, in addition to quickly losing their effectiveness. This is because the nanoneedle arrays are normally placed on rigid silicon wafers.

“To tackle this problem, we developed a method that enables physical transfer of vertically ordered silicon nanoneedles from their original silicon wafer to a bio-patch,” said Chi Hwan Lee, assistant professor at Purdue University. “This nanoneedle patch is not only flexible but also transparent, and therefore can also allow simultaneous real-time observation of the interaction between cells and nanoneedles.”

Scientists at Purdue University and South Korea’s Hanyang University have now developed flexible and translucent platform for silicon nanoneedle patches, allowing for accurate and minimally invasive drug delivery straight into living cells.

The nanopatches can not only be placed on the skin, but between muscles and within tissues for long term implantation. For on-skin applications, the patches remain translucent and so the tissue underneath can be monitored fairly well while it’s healing.

“This means that eight or nine silicon nanoneedles can be injected into a single cell without significantly damaging a cell. So we can use these nanoneedles to deliver biomolecules into cells or even tissues with minimal invasiveness,” said Chi Hwan Lee.

 

Study in Science Advances: Flexible elastomer patch with vertical silicon nanoneedles for intracellular and intratissue nanoinjection of biomolecules…

Via: Purdue University…

Point-of-Care BRCA1 Mutation Testing in 20 Minutes

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BReast CAncer gene one (BRCA1) is one of the best-known genes linked to breast cancer risk. Unfortunately, the technology to spot the gene requires a lab and expertise at interpretation. Researchers at Louisiana State University have now developed a smartphone-based system called FLuoroZen that can test for the cancer-related BRCA1 mutation at the point-of-care within twenty minutes.

The FLuoroZen analyzes DNA within saliva or blood when the sample is placed on nitrocellulose paper, itself placed on a glass slide. The device then detects the fluorescent oligonucleotide spots on the nitrocellulose paper thanks to two filters that screen out all except for two different frequencies of light. One of the light frequencies excites the fluorescent dye and the second is used to help measure the light spectrum that is emitted.

Spots that are brighter indicate the presence of the mutated version of the BRCA1 gene. The difference in the light intensity between positive and negative spots is not very strong, but a smartphone with a special app can tell the difference and produce final results.

The technology can not only work for detecting BRCA1 mutations. “Utilizing paper microfluidics for biological assays, along with the smartphone readout setup opens up the possibility of transferring various clinical, as well as environmental, tests to POCT,” said Manas Gartia, assistant professor at Louisiana State. “Dr. Melvin [LSU Chemical Engineering Professor Adam Melvin] is interested in finding neurotoxins and hepatotoxins, such as microcystin and cyanopeptolin, due to harmful golden algal blooms found in Lake Pontchartrain. If we can attach that toxin to a fluorescent dye, then we can detect whether that particular toxin is in your water sample.”

Via: Louisiana State University…

Via: LSU…


PerQseal Absorbable, Sutureless Large-Bore Closure Device Coming to Europe

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Vivasure Medical, a Galway, Ireland company, is launching in Europe its PerQseal closure device for use in large vessel femoral arteriotomies following large-bore transcatheter procedures, such as aortic valve replacements. Though minimally invasive transcatheter procedures have revolutionized cardiovascular care, closing the access sites created for them can be challenging.

The PerQseal device is sutureless and, once placed, fully absorbable into the body. The synthetic-material patch seals the vessel from the interior, slowly dissolving and letting the vessel heal naturally.

“In my first clinical experience with PerQseal, I found the device intuitive and well controlled, which helped me quickly learn how to use the technology safely and successfully,” in a statement said Dr. Saib Khogali, Heart & Lung Centre, New Cross Hospital Wolverhampton, UK. “I believe the PerQseal has the potential to be an important large-hole closure device in many TAVR and EVAR patients.”

 

Here’s an animation showing off the functionality of the PerQseal device:

Technology info page: PerQseal…

Flashback: Bioabsorbable PerQseal Vivasure Large Bore Femoral Closure Device Cleared in EU…

Via: Vivasure Medical

Medtronic’s Valiant Navion Thoracic Stent Graft Cleared in EU

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Medtronic won European CE Mark approval to introduce its Valiant Navion thoracic stent graft for treating lesions within the descending thoracic aorta such as thoracic aortic aneurysms (TAA), blunt traumatic aortic injuries (BTAI), and penetrating atherosclerotic ulcers (PAU). The system received FDA approval in October of this year.

The Valiant Navion is particularly beneficial for patients with narrow iliac arteries, in whom previously developed minimally invasive access could has been difficult and additional procedures may have been required just to get started.

The new product is based on the Valiant Captivia thoracic stent graft system, but thanks to its narrower profile allows for improved navigation through tortuous anatomy. It comes with two different stent configurations: CoveredSeal (proximal covered) and FreeFlo (proximal bare metal). These two options give physicians an ability to treat a wide range of patients.

“In clinical practice we often see patients with a wide range of thoracic aortic anatomies. For example, TEVAR in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure,” in a published statement said Professor Fabio Verzini, M.D., Ph.D., associate professor of Vascular Surgery, University of Turin. “The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients and those who were previously considered ineligible for TEVAR with a percutaneous approach.”

Product page: Valiant Navion…

Flashback: FDA Approves Valiant Navion Thoracic Stent Graft for Patients with Narrow Iliac Arteries…

Via: Medtronic…

Adaptive Vapor Ablation for Menstrual Bleeding: Interview Maria Sainz of AEGEA Medical

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Heavy bleeding during menstruation, known as menorrhagia, is often treated by endometrial ablation. There’s a number of methods of doing so, including delivery of heat, cold, and microwaves, but each has a number of downsides and limitations.

AEGEA Medical is a Silicon Valley company that has developed a unique technology, called adaptive vapor ablation, that allows physicians to treat menorrhagia in a five minute procedure that doesn’t require cervical dilation, nor any direct contact with the uterine fundus.

We were curious and wanted to find out more and had an opportunity to pose a few questions to Maria Sainz, the President and CEO of AEGEA Medical.

 

Medgadget: Endometrial ablation is currently performed using microwave energy, radiofrequency energy, or direct heat or cold. What are the downsides of these methods in practice?

Maria Sainz, President & CEO of AEGEA Medical: Physicians have performed endometrial ablation for over 15 years to treat menorrhagia, or heavy menstrual bleeding. Endometrial ablation is intended only for premenopausal women who no longer want to have children in the future. Historically, procedures have typically been performed in the operating room with the majority of patients being put under general anesthesia. Consequently, the procedure itself has traditionally been involved and the recovery has been prolonged for a patient. There has been an increasing desire to move procedures to an office setting, which can be easier and more comfortable for patients, and more convenient for physicians.

 

Medgadget: Can you describe how the AEGEA system differs and how it works?

Sainz: The AEGEA Vapor System is the first FDA-approved endometrial ablation system specifically designed for use in the doctor’s office. Rapid and easy to perform without use of general anesthesia, AEGEA provides a new treatment option for menorrhagia. Patient recovery times are short, with the majority of patients returning to work within two days or less.

The AEGEA system is the only endometrial ablation product that uses water vapor for treatment. Harnessing the ability of natural water vapor to efficiently conform to each woman’s unique anatomy, the system enables the ablation medium to be delivered through a very small and flexible probe that does not require dilation or uncomfortable high pressure within the uterine cavity. Low pressure water vapor (water in a gas state) has been demonstrated in clinical trials to safely and uniformly expand inside the uterine cavity and transfer thermal energy to the uterine wall. The efficiency of water vapor to carry and distribute energy enables the rapid two-minute treatment time. The conformability of vapor also enables efficient treatment of a broader range of patients compared to prior endometrial ablation therapies.

The AEGEA Vapor System has two parts: the re-usable Vapor Generator and the disposable Vapor Probe. The Vapor Generator has an intuitive touch screen with instructions; the Vapor Probe has a small flexible tip through which vapor is delivered to the uterus, and the system uses first-in-class safety features.

 

Medgadget: What are the procedural benefits from the point of view of the physician?

Sainz: The AEGEA Vapor System is an in-office treatment option for endometrial ablation that is safe, simple and effective, as demonstrated in the company’s pivotal trial data that was the basis for FDA approval. Seventy-three percent of the U.S. procedures from the pivotal trial were performed in the office setting. No serious device or procedure-related adverse events were reported through the study’s 12-month clinical follow-up. The majority of patients had a reduction of their menstrual bleeding to normal levels or had no period at all. Treatment time is two minutes, and the system is fully automated.

The AEGEA Vapor System enables a broader spectrum of patients to have access to endometrial ablation. Vapor ablation treats larger cavities (up to 12 cm in uterine cavity length) as well as cavities with certain fibroid types. Competitive devices can only treat uterine cavity lengths up to 10 cm and did not include women with fibroids in their FDA trials.

In addition, a new research study is underway to evaluate uterine cavity access following endometrial ablation. AEGEA believes this is a very important success metric for the therapy, as it speaks to the possibility of future uterine-related interventions. Pilot data on 11 patients treated with Adaptive Vapor Ablation technology has demonstrated that Vapor Ablation has the potential address this unmet need, potentially preserving physician and patient options in the future.

 

Medgadget: What about the outcomes? What should patients expect?

Sainz: One year after the treatment in the pivotal study, the following results were seen:

6X reduction in menstrual bleeding per pivotal study criteria
90 percent had bleeding reduced by ≥50 percent
85 percent had bleeding that was reduced to a normal level or less per scientific literature
99 percent experienced an improvement in quality of life 12 months post-treatment
93 percent would recommend the procedure to a friend
91 percent were satisfied or very satisfied 12 months after the procedure

Additionally, 85 percent of patients whose periods affected their sex lives reported an improvement in their sex life after treatment.

The pivotal trial data showed that the AEGEA Vapor System was safe, with no serious device or procedure-related adverse events reported. The reported adverse events were consistent with the anticipated types and frequency of adverse events reported from previous studies of endometrial ablation devices that have FDA approval.

As stated above, patient recovery times are short, with the majority of patients returning to work within two days or less.

 

Medgadget: What is your current regulatory status in the U.S. and otherwise?

Sainz: The AEGEA Vapor System is FDA approved to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete. Regulatory approvals outside of the U.S. are under evaluation.

 

Medgadget: How has your system been adopted where you have been marketing it so far?

Sainz: AEGEA is currently developing a next generation ablation system with the business objective of developing a scalable manufacturing platform. Commercialization is expected to occur in 2019.

 

Medgadget: What are you hearing from patients and physicians?

Sainz: A number of physicians and patients in the company’s pivotal trial provided testimonials about their experience with vapor ablation. Representative statements are provided below:

Here’s an animation describing the AEGEA Vapor Ablation procedure:

Disclaimer: As with all surgical procedures, there are risks and considerations associated with use of the AEGEA Vapor System. Please refer to the device labeling for a detailed discussion of the device’s intended use, relevant warnings, precautions, side effects, and contraindications. Patient and Physician labeling are provided on the AEGEA website, www.aegeamedical.com.

Info page: AEGEA Vapor System…

Cedars-Sinai’s New App Offers Walking Directions Around Hospital

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Hospitals can be famously difficult to navigate, and conventional GPS mapping apps don’t really help get through an indoor maze. Cedars-Sinai medical center in Los Angeles is solving this problem with its own smartphone app. The new Cedars-Sinai app has a built-in interactive map that gives step-by-step walking directions between any two points within the hospital.

It can help find different clinical departments, as well as bathrooms, dining areas, and things like ATMS and parking. Speaking of parking, the app can help save your parking spot and lead you right back to the exact location where you left your car.

“The opportunity to create a positive experience starts well before our patients walk through the doors,” said Cedars-Sinai’s Chief Patient Experience Officer Alan Dubovsky. “With these exciting digital tools working hand-in-hand with the medical center’s new physical wayfinding resources, we’ve crafted a holistic approach to getting people where they have to be so that they can focus on receiving the care they need.”

Via: Cedars-Sinai…

REVA’s Fantom Encore Thin Strut Bioresorbable Scaffold Unveiled

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REVA Medical, out of San Diego, California, has released its Fantom Encore bioresorbable scaffold. The implant is made with the company’s own Tyrocore polymer that is absorbed by the body over a period of time, eventually disappearing while native tissue takes over. The process helps to make sure that the lumen stays open while cells grow and rebuild the native structure of the vessel.

This is the company’s third generation of bioresorbable scaffolds, and it is CE Marked in Europe and available in a number of countries. The new device has thinner struts compared to other similar coronary artery bioresorbable devices. It is visible under fluoroscopy thanks to its radiopaque material.

“My experience with Fantom Encore is that it is easy to use due to its thinner strut profile, x-ray visibility, and strength,” said Dr. Matthias Lutz at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany. “With these device improvements and the investment in the FANTOM Post Market Trial, REVA is partnering with physicians to advance the field of bioresorbable scaffolds.”

Product page: Fantom Encore…

Via: REVA…

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