Boston Scientific’s Vercise Neurostimulation System Approved for Parkinson’s in U.S.

Boston Scientific won Food and drug administration approval because of its Vercise Deep Brain Stimulation System to treat Parkinson’s. The implantable stimulator could be programmed in a number of methods to target different parts of the subthalamic nucleus. This might help to lessen the signs and symptoms of Parkinson’s by delivering therapy within an optimal method for each patient.

The implant is rechargeable and may last for greater than fifteen years. Each one of the eight electrodes around the leads could be controlled individually. The electrodes get in touch with brain tissue along a 15.5 millimeter length, meaning they’re separated by only .5 millimeters.

We’ve got the technology was already obtainable in Europe during the last 5 years.

Here’s some good info around the trials that brought towards the approval, based on Boston Scientific:

Your application took it’s origin from the Smart study, the very first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for PD within the U.S. The Smart study evaluated the security from the system in 292 patients at 23 sites as well as evaluated its usefulness. It effectively met its primary endpoint of mean alternation in waking hrs with higher symptom control (n=160). Data in the Smart study is anticipated to be sold in 2018. The filing seemed to be based on safety data in the European multi-center, prospective, single-arm VANTAGE study. Within the VANTAGE study, 40 patients given the Vercise DBS System shown a 63 percent improvement in motor function at 52 days from baseline as measured through the Unified Parkinson’s Disease Rating Scale III, in addition to enhancements in quality of existence and medicine usage.

Flashbacks: Vercise Gevia Deep Brain Stimulation System with Visual Brain Targeting Software Removed in Europe… Boston Scientific’s Vercise Deep Brain Stimulator Will get Expanded Indication in Europe for Dystonia… Vercise Deep Brain Neurostimulator EU Approved for Tremor (VIDEO)… Boston Sci’s Vercise DBS for Parkinson’s Removed in EU…

Via: Boston Scientific…


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3D Printing Helps you to Implant Dangerous Transcatheter Mitral Valves

Transcatheter aortic valve implantations are actually routine at numerous high-finish hospitals all over the world. Non-invasive mitral valve replacements, however, are much harder and vulnerable to publish-op complications, and they are still a rarity. Yet, 60% of patients over 75 have mitral valve disease, and it is a level bigger problem than aortic valves. We visited the Henry Ford Hospital in Detroit to discover a cutting-edge program where clinicians use 3D printing and computer simulations to assist install substitute mitral valves without getting to turn to open surgery.

The Middle for Structural Cardiovascular Disease at Henry Ford Hospital is headed by Dr. William O’Neill, a master within the field, who came back to Detroit carrying out a sting at College of Miami School Of Medicine. Dr. O’Neill and the team created a process and compiled the various tools and devices essential to pre-plan transcatheter mitral valve replacements (TMVR). They labored with Materialise, a 3D printer located in Plymouth, Michigan, so that you can consistently convert CT scans of hearts into computer simulations and 3D printed hearts that may be examined and manipulated to determine what valves to implant where to put them.

Though each one of the bits of this method, for example CT checking and 3D printing, aren’t uncommon, tying them together continues to be challenging. We spoken with Bryan Crutchfield, a VP and GM of Materialise’s United States operations, who described that converting CT scan data into 3D printer files is itself an elaborate process. To create helpful models, the organization developed software that cleans up many of the noise and physiological fragments, after which clinicians with the aid of Materialise’s specialists perform some manual computer try to define the ultimate model. These models will be printed immediately in the hospital and could be examined and evaluated for various valves. Once that’s done, the process turns into a lot simpler and could be performed with greater confidence, resulting in much improved clinical outcomes. And also the figures show this.

We spoken with Dr. Dee Dee Wang, a cardiologist who’s Director of Structural Heart Imaging at Henry Ford Hospital and Medical Director of 3D Printing at Henry Ford Innovation Institute concerning the challenges of mitral valve implantation and just how she overcomes these challenges using today’s technology. The mitral anatomy is much more complex compared to aortic one, requiring significantly more intending to make certain an implant is positioned properly and fits the patient’s anatomy. One of the most common complications of non-invasive mitral valve implantations remains output tract obstruction. This occurs once the new valve protrudes in to the ventricular output tract, creating one other issue altogether. Sometimes the valve embolizes since it detaches from its implant site and floats away, creating an urgent situation that may simply be worked with open heart surgery. Since patients receiving transcatheter mitral valves happen to be high-risk for open heart surgery, this really is clearly a vital problem.

Dr. Wang described to all of us that about 20% of TMVR procedures using conventional imaging and sizing result in left ventricle output tract (LVOT) obstructions, that are also hard to reverse and wish open heart surgery. CT scans don’t supply the intuitive depth perception required to size new valves properly and calcified regions are poorly defined, which makes it a lot more of a guessing game. During open mitral valve procedures surgeons really stick types of valves in to the anatomy to determine what will be a good fit, however this doesn’t seem possible inside a non-invasive procedure. Top quality 3D prints, however, reproduce this method making it clear to see the anatomy and different challenges of positioning a valve inside a difficult place without them protruding an excessive amount of in to the left ventricle output tract.

The printed models are within one millimeter precision from the patient’s own hearts and also have the necessary depth and handling to have an interventional cardiologist so that you can alter to determine what valve to insert where to deploy it. Dr. Wang appears proud the manufacturing and prototype approach that they’ve taken at Henry Ford for repairing hearts mirrors Detroit and it is auto industry. She’s developed quite an accumulation of 3D printed patient hearts, that is beginning to appear enjoy it may eventually be considered a museum collection. They are still helpful devices, as they possibly can be referred to when similar patient cases are available in.

Our trip to Henry Ford was exciting and academic so we were quite astounded by we’ve got the technology that’s used in challenging transcatheter mitral valve procedures.

Finally, here’s a relevant video story in regards to a 16 year-old with a number of heart disease which was helped by doctors by 3D printing his heart when preparing for that procedure:

Links: Materialise homepage and the company’s Products for Cardiologists and Cardiac Surgeons…

Related study in JACC: Cardiovascular Imaging: Predicting LVOT Obstruction After TMVR…

Nanoparticles Laden with Tapeworm Drug Stop Activity of Cancer Stem Cells

Researchers in the College of Illinois will work on stopping the metastasis of cancer by utilizing nanoparticles laden with drugs to deactivate cancer stem cells. Cancers frequently spread via cancer stem cells that may reappear and also be new tumors lengthy following a patient has been around remission. The Illini researchers were able to target these cells by getting their nanoparticles affix to the protein CD44, one found only at first glance of cancer stem cells. To deactivate the game of those cells, the drug niclosamide, typically accustomed to treat tapeworms, was connected to the nanoparticles. It really works against cancer stem cells since it prevents the game of the gene pathways that provide these cells stem-like qualities, a well known fact discovered through the Illinois researchers previously.

The treatment was tested on cultures of cancer of the breast cells, and also on laboratory rodents with cancer of the breast tumors. The findings demonstrated the cancer stem cells were mostly deactivated, stopping them from distributing the condition throughout all of those other body. Furthermore, the overall cancer cell count went lower within the cultured cells and also the model rodents.

There’s a lot of promise with this technology to become relevant to real-world cancer patients, so we’re wishing this will quickly result in trials outdoors the laboratory.

Study in journal Molecular Cancer Therapeutics: Targeted Delivery of STAT-3 Modulator to Cancer Of The Breast Stem Like Cells Lower-regulates a number of Stem-liness Genes…

Via: College of Illinois…


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High-speed Video Precisely Captures Bloodstream Cell Velocity

Researchers at ITMO College in Saint Petersburg, Russia, allow us a non-invasive high-speed video capillaroscopy system that may precisely appraise the velocity of bloodstream cells flowing through capillaries within the skin around a finger nail. The process might be helpful in assessing cardiovascular conditions.

Capillaroscopy systems provide a easy and non-invasive method to measure the shape and size of capillaries or capillary systems, which could reflect the health of the whole vascular network. Another possibility is calculating the rate of bloodstream cells within the capillaries, which could showcase overall bloodstream flow velocity. This post is helpful in conditions for example diabetes and heart disease.

“Flow velocity is very central in estimating the health of any tissue by its bloodstream supply. For example, in diabetes the circulation speed may alter despite the fact that bloodstream vessels generally seem to be normal,” states Nikita Margariants, among the researchers active in the study.

So far, techniques to measure bloodstream velocity in capillaries haven’t been very accurate or reliable. “There are alternative devices that may only provide a rough average estimate of bloodstream cell velocity,” states Mikhail Volkov, another investigator active in the study.

The study team’s solution involves optical equipment, high-speed video capture, and specifically designed software. When pressed from the skin beside a finger nail, their device can capture high-speed video of red bloodstream cells flowing through capillaries. Then, the program processes the frame sequence to evaluate the form and configuration from the capillaries, combined with the distance the red bloodstream cells travel per unit time. The process enables for very precise velocity measurements.

“Although easy, our device is capable of doing supplying reliable data that may be very helpful for disease pattern recognition,” states Igor Gurov, lead author around the study. “What is much more, this type of diagnostic procedure is completely painless, comfortable and safe for patients.”

“Our primary task now is by using the machine to deal with socially significant illnesses. Particularly, the machine is definitely an effective tool for studying what goes on in bloodstream vessels during heart disease and just how drugs affect bloodstream flow recovery,” states Margariants

Assessment of bloodstream flow velocity. Credit:

Study in Optics and Lasers in Engineering: High-speed video capillaroscopy way of imaging and look at moving red bloodstream cells…

Via: ITMO University…

First Digital Camera for Opioid Withdrawal Therapy Approved by Food and drug administration

The Food and drug administration has provided a regulatory eco-friendly light towards the first device that reduces opioid withdrawal signs and symptoms. The NSS-2 Bridge from Innovative Health Solutions, a Versailles, Indiana firm, is stuck towards the skin behind the ear and depends on four electrodes which are attached round the ear. The electrodes are utilized to deliver electric energy to some occipital and cranial nerves (V, VII, IX, and X), hopefully helping addicts to prevent agitation, insomnia, along with other signs and symptoms of kicking opioids. Exactly the same device was authorized by the Food and drug administration 3 years ago to be used in acupuncture and also the current approval went under the de novo review process meant for distinctively new low to moderate risk technologies.

The Food and drug administration based its decision on the study involving 73 patients which were experiencing physical signs and symptoms of withdrawal. Before while using NSS-2 Bridge, the topics had an average clinical opiate withdrawal scale (COWS) score of 20.1 (the greater, the more serious the signs and symptoms). While using device, the topics had a decrease in the COWS score by a minimum of 31% within 30 minutes of therapy activation. Furthermore, 64 from the 73 patients switched to medication aided therapy after 5 days of utilizing the NSS-2 Bridge.

The unit needs a prescription and isn’t supposed to have been utilized by patients using pacemakers or that suffer from hemophilia or skin psoriasis.

Product page: NSS-2 BRIDGE…

Via: FDA…


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Optical Fiber Pajamas Illuminate to deal with Jaundice in Newborns

Kids born with jaundice need to spend a large amount of amount of time in an illuminated incubator before they are able to metabolize bilirubin hepatically. Nobody likes this, because the child needs to be taken from the parents to invest time in the glass box.

At the Swiss Federal Laboratories for Materials Science (Empa), a brand new illuminated fabric continues to be developed you can use to create baby pajamas that literally blanket the kid see how to avoid. There are technologies that resemble this, like the Biliblanket, but Empa’s technology integrates optical fibers which are no wider than regular thread, directly into traditional clothing fabrics. This will make it easy to use, feel at ease like other baby clothing, and natural for that parents to carry their children during therapy.

Since low power LEDs are utilized because the source of light, small batteries are sufficient to power the material, meaning the pajamas don’t need to be tethered to wall power.

The secret from the technologies are to slightly and precisely bend the optical fibers, from time to time, so that they leak light from the bends. With no bends, the fibers transmit the majority of the light through themselves in one finish to another. Maintaining precisely calculated angles of every optical fiber as it’s woven using the traditional fiber produces a well distributed light pattern.

Study in Biomedical Optics Express: Plenty of fish-yarn weaves: manipulating the light out-coupling of wearable phototherapy devices…

Via: Empa…


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Researchers Stick Microscopes Inside Mouse Brains to look at Live Neuro Activity

Scientists at the California Institute of Technology allow us a means of implanting an optical lens into the amygdala of the living mouse’s brain to look at the neural activity happening. The lens is really a thin glass fishing rod that’s pressed deep in to the brain, while an imaging microscope linked to it lets the scientists take a look inside.

When rodents communicate with man or woman rodents, different brain activity patterns illuminate. Within the medial amygdala, some neurons react to males (eco-friendly), some react to females (red), along with other neurons react to both sexes (yellow).

Obviously, the mind is of course dark there aren’t any sparks whenever generate an excellent idea. But, using a little bit of genetic engineering, the scientists introduced a fluorescent protein in to the neurons from the rodents being studied so the cells release it whenever they’re active.

They then introduced the rodents with other rodents, both men and women, and viewed which neurons appeared to be activated. They discovered that some neurons only illuminated when males were present, while some reacted simply to females, but others illuminated to both sexes. Correlating the social activity from the rodents towards the neural activity happening in their brains permitted the scientists to create new findings, for example really the way the brain changes over long periods as the mouse adapts to new social situations. They could conduct studies for periods of time as lengthy as three several weeks, a remarkable task that reveals an enormous amount of other studies that can help us to know how our minds work and the way to fix the illnesses that they’re prone to.

Related papers: Study in Nature: Social conduct shapes hypothalamic neural ensemble representations of conspecific sex… Study in Cell: Neuronal Representation of Social Information within the Medial Amygdala of Awake Behaving Mice…

Via: Howard Hughes Medical Institute…


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Shift Labs Wins 2017 Global Health Innovator Award in the MedTech Conference

Shift Labs may be the champion from the 2017 Global Health Innovator Award. The award was presented in the MedTech Conference which required place recently in Santa Clara, CA. This is actually the award’s inaugural year and it was due to the conference’s new Innovations in Global Health Program, which puts an emphasis on medical innovation within the third world. Additionally towards the recognition of the technology’s sustainability and impact in resource-restricted areas, Shift Labs also receives $50,000 using the award supplied by both TEAMFund and MedTech Innovator with support from industry leaders including BD, Medtronic, and Stryker. TEAMFund (Transforming Equity and Access in Medtech) is really a combination non-profit and impact fund having a pursuit to expand use of affordable medical technologies that address unmet needs in underserved parts around the globe. MedTech Innovator is really a nonprofit global competition and accelerator for medical technologies having a goal to enhance patient lives by  speeding up companies who’re making an effect in healthcare.

Captured, Shift Labs guaranteed CE Mark approval and also offers Food and drug administration approval for his or her DripAssist Infusion Rate Monitor. The unit addresses the requirement for better, simple to use tools for IV infusions that don’t presently appear in settings where challenges connected with cost, infrastructure, training, and offer chains are typical. DripAssist lowers the barrier to properly administering IV infusions by permitting any healthcare worker to put together an infusion and monitor the speed where the infusion is delivered. The unit may be the only portable, AA battery-powered IV infusion tool to become both CE-marked and Food and drug administration-removed. Up to now, the unit has witnessed use within over 24 countries from Zimbabwe towards the U . s . States.

Shift Labs Chief executive officer Janet Kolko, a professor of Human Centered Design & Engineering in the College of Washington, commented around the recognition, “As a company, Shift Labs is honored to get this award, and we’re extremely excited since the TEAMFund initiative aligns very well with this vision of making sustainable medical devices that suit the requirements of many markets worldwide.”

Flashbacks: Applying Human Centered Design to IV Infusions: Interview with Dr. Janet Kolko, Chief executive officer of Shift Labs… CE Mark Approval for Shift Labs’ DripAssist Infusion Rate Monitor… Drip Clip Estimates IV Drug Delivery, Helps Ready Your Absinthe… Shift Labs’ DripAssist Infusion Rate Monitor Earns Popular Science 2016 “Best of What’s New” Recognition in Health Innovations… Shift Labs Planning to Release DripAssist, Bring Controlled IV Drips to Developing or Disaster-Struck Regions By Finish of Year…

Link: Shift Labs…

Michael Batista

Michael Batista is really a Baltimore-based editor motivated by disruptive innovation in the intersection of technology and healthcare. He holds a dual B.S. in materials and bioengineering from Durch and conducted graduate operate in biomedical engineering at Johns Hopkins within the Center for Bioengineering Innovation and style. At Johns Hopkins, Michael was involved with initial phase medical technology development before diving into the field of digital healthcare. Since 2014, he’s been the Chief executive officer from the digital health startup, Quantified Care (https://world wide

Abbott’s Confirm Rx Implantable Cardiac Monitor Connects to Smartphones, Food and drug administration Removed

Individuals at Abbott received Food and drug administration clearance for that Confirm Rx implantable cardiac monitoring device that wirelessly connects towards the patient’s smartphone. Cardiac tracks pass in the device towards the smartphone after which to the company’s online portal where cardiologists can observe the information anytime. By having the ability to immediately share occasions using the physician, patients could be diagnosed faster whether and what sort of cardiac arrhythmias they’ve already.

The individual simply installs the myMerlin application on their own phone and uses Bluetooth to sync towards the implant. An agenda is placed to maneuver saved data in the device, towards the phone, and also to the internet portal. All of the data transfers are encrypted to make sure privacy. If your patient feels that something might be happening using their heart, they are able to make use of the application to record time from the event and signs and symptoms being experienced. That’s pretty convenient, like a separate system is not needed to assist synchronize the cardiac waveforms towards the signs and symptoms, and time they happen.

A pleasant additional feature would be that the Confirm Rx is conditionally safe, meaning that it may be implanted as the patient receives an MRI scan, as lengthy as certain safeguards are taken into consideration.

Product page: Confirm Rx ICM…

Via: Abbott…


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Butterfly iQ, an entire body Ultrasound That Matches inside a Pocket

Butterfly Network, a strong located in Guilford, Connecticut, won Food and drug administration clearance and it is presenting its Butterfly iQ portable ultrasound system. It includes a portable transducer that connects straight to an apple iphone, as well as an iOS application to show the pictures and also to control settings.

The unit really works as three different transducers because of an ultra wide band matrix array. This enables a clinician to carry out a couple of different scans but for the Butterfly iQ to become relevant in various clinical settings. The matrix variety of microelectromechanical (MEMS) sensors is directly integrated onto a built-in circuit which contains all of the necessary electronics. This tight integration supposedly produces a fast, high-resolution device that may perform tasks that just full-sized ultrasound machines were capable only a couple of short years back. The firm compares its technology to how photo camera sensors happen to be integrated within smartphones, enabling anybody to possess top quality photo imaging within their pocket.

Possibly the greatest cope with the Butterfly iQ is it costs under $2,000. Previous portable, hands-held ultrasounds have frequently been costing greater than $10,000.

This can be a promo video for that Butterfly iQ:

Listed here are a few videos taken while using new device:

Product page: Butterfly iQ…

Via: Butterfly Network…


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